Pan African Clinical Trials Registry

South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202303578406229 Date of Registration: 15/03/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of video-based nutrition education targeting on animal source food consumption, dietary diversity and nutritional status of 6-23months of children in selected districts of Konso Zone,Southern Ethiopia.
Official scientific title Effect of video-based nutrition education targeting on animal source food consumption, dietary diversity and nutritional status of 6-23months of children in selected districts of Konso Zone, southern Ethiopia.
Brief summary describing the background and objectives of the trial Background: - Undernutrition in under-five children is not effectively reduced by a single intervention, therefore an emerging framework for improving diet quality involves video based nutrition education system. Behavior change communication (BCC) is crucial for improving maternal and child nutritional status and adherence to recommended practices during pregnancy, lactation, and early childhood. Video can be used for engagement, empowerment, motivation, and connection among community members. In rural Ethiopia, children's diets are often monotonous, cereal-based, and low in energy and nutrient density. Objective: - To assess the effect of video based nutrition education targeting on animal source food consumption, dietary diversity and nutritional status of 6-23months of children in selected Districts of Konso Zone. Method: - A community based cluster Randomized control trial will be conducted from December 2023- August 2024 in 337 (168 intervention & 168 control) mothers who have children from 6-23 months. A total of 20 clusters will be identified and randomly assigned (10 clusters for intervention and 10 clusters for control), with a total of 16 participants in each small cluster or village. Each household in the intervention clusters mothers who have chickens in their house will receive education using video-based nutrition education on diversified diets, promotion of poultry production, and consumption of eggs. The control group is those who do not have chickens in their homes and will not receive video-based nutrition education. Baseline and end-line outcome measures—anthropometric data, dietary intake, hemoglobin level, and feeding practice—will be assessed. Data will be collected through interviewer-administered questionnaires using an open data kit (ODK) and then exported to STATA version 14 for analysis. Anthropometric data analysis will be done by WHO Anthro v. 3.2.2. Both macro- and micronutrient intakes will be analyzed by the Nutri-Sur
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/12/2023
Actual trial start date 01/12/2023
Anticipated date of last follow up 01/03/2024
Actual Last follow-up date 30/08/2024
Anticipated target sample size (number of participants) 337
Actual target sample size (number of participants) 337
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Dynamic (adaptive) random allocation such as minimization Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group No Nutrition Intervention six month no 168 Uncontrolled
Experimental Group Nutrition intervention one egg per day and video based nutrition education per 2 week nine month Each household in the intervention cluster will have egg-laying chickens, and mothers will receive education using video-based nutrition education on a diversified diet, promotion of poultry production, and consumption of eggs. 2
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Mothers who had children aged 6-23months children living in the study area. • Age of child 6 -23months • Mothers with children 6-23 months living more than 6 months in study area. Severely ill child and households planning to move out of the study area after base survey. • Vulnerable groups if the trial isn't designed for them. • History of chronic disease or malnourished children and treatment history for severe acute malnutrition. • Children those have history of treatment and admitted for severe acute malnutrition • Participated in other nutrition intervention. hard to reach and food insecure area Infant: 13 Month(s)-24 Month(s) 6 Month(s) 23 Month(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 04/01/2024 Hawassa University College of Medicine and Health sciences institutional review board
Ethics Committee Address
Street address City Postal code Country
Hawassa Hawassa 1560 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Nutritional status, animal source food consumption and anemia Base line and endline
Secondary Outcome complementary feeding practice, dietary diversity End line
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Konso Zone Ethiopia Karat zuriya and Kena Woreda, Konso zone, Ethiopia Konso Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Hawassa University Hawassa Hawassa 1560 Ethiopia
Arba Minch University Gamo zone, South region Ethiopia Arba Minch Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Arba Minch University Arba Minch Arba Minch 21 Ethiopia University
Secondary Sponsor Hawassa University Hawassa Hawassa Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Meseret Girma meseretgirma_abate@yahoo.com +251911836862 Arba Minch
City Postal code Country Position/Affiliation
Arba Minch 21 Ethiopia Assistant professor
Role Name Email Phone Street address
Public Enquiries Meseret Girma meseretgirma_abate@yahoo.com +251911836862 Arba Minch
City Postal code Country Position/Affiliation
Arba Minch 21 Ethiopia Assistant professor
Role Name Email Phone Street address
Scientific Enquiries Meseret Girma meseretgirma_abate@yahoo.com +251911836862 Arba Minch
City Postal code Country Position/Affiliation
Arba Minch 21 Ethiopia Assistant professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data from this study may be made available to qualified researchers with a focus on human nutrition. Shared information or samples will be encoded. Data sharing with the requesting party is subject to approval of the request and execution of all relevant agreements (such as a material transfer agreement). Statistical Analysis Plan,Study Protocol Data requests can be submitted starting 12 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis. Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Public title 21/02/2024 Adivsor recommendation Effect of Integrated poultry value chain and Video Based Nutrition education on Dietary quality, nutrient intake and nutritional status of children 6-23 months in Konso Zone, Southern Ethiopia: Community based a cluster Randomized control trial. Effect of video-based nutrition education targeting poultry value chain on animal source food intake, dietary diversity and nutritional status of 6-23months of children in selected districts of Konso Zone,Southern Ethiopia.
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Public title 10/07/2025 editorial issue Effect of video-based nutrition education targeting poultry value chain on animal source food intake, dietary diversity and nutritional status of 6-23months of children in selected districts of Konso Zone,Southern Ethiopia. Effect of video-based nutrition education targeting on animal source food consumption, dietary diversity and nutritional status of 6-23months of children in selected districts of Konso Zone,Southern Ethiopia.
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Official scientific title 21/02/2024 Adivsor recommendation Effect of Integrated poultry value chain and Video Based Nutrition education on Dietary quality, nutrient intake and nutritional status of children 6-23 months in Konso Zone, Southern Ethiopia: Community based a cluster Randomized control trial. Effect of video-based nutrition education targeting poultry value chain on animal source food intake, dietary diversity and nutritional status of 6-23months of children in selected districts of Konso Zone, southern Ethiopia.
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Official scientific title 10/07/2025 editorial issue Effect of video-based nutrition education targeting poultry value chain on animal source food intake, dietary diversity and nutritional status of 6-23months of children in selected districts of Konso Zone, southern Ethiopia. Effect of video-based nutrition education targeting on animal source food consumption, dietary diversity and nutritional status of 6-23months of children in selected districts of Konso Zone, southern Ethiopia.
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial description 21/02/2024 Adivsor recommendation Back ground: - Under nutrition in under-five children do not effectively reduced by single intervention, therefore an emerging framework for improving diet quality involves value chains system. Poultry production with the majority of free-range chickens is widely practiced in rural communities of low-income countries. Chickens and their eggs are important sources of income and food for the family. Eggs are nutritious with high quality protein and several macro-and micro-nutrients. Evidences showed that increased consumption of eggs improved the nutritional status of children. Therefore; this study designed to improve child nutrition through integrated poultry value chain intervention in selected Districts of Konso Zone, Southwest Ethiopia. Objective: - To assess the effect of integrated poultry value chain and video based nutrition education interventions on improving dietary quality, nutrient intake and nutritional status of 6-23months of children in selected Districts of Konso Zone. Method: - Community based a cluster Randomized control trial study will be conducted from October 2023- April 2024 in mothers who have children from 6-23 months. A total of 20 clusters will be identified and randomly assigned to (10 cluster intervention and 10 clusters for control) with a total of 23 participants in each small clusters or village. Each households in intervention clusters will receive a gift of two egg laying chickens and mothers will receive education by using video based nutrition education on diversified diet, promotion of poultry production and consumption of egg. The control group will receive nutrition education given by the local health extension workers and health institution. Baseline and end line outcome measures anthropometry to measure nutritional status, dietary intake, hemoglobin level and dietary feeding practice will be assessed. Data will be collected through interviewer administered method using standardized questionnaire. Background: - Undernutrition in under-five children is not effectively reduced by a single intervention, therefore an emerging framework for improving diet quality involves video based nutrtion education system. Behavior change communication (BCC) is crucial for improving maternal and child nutritional status and adherence to recommended practices during pregnancy, lactation, and early childhood. Video can be used for engagement, empowerment, motivation, and connection among community members. In rural Ethiopia, children's diets are often monotonous, cereal-based, and low in energy and nutrient density. Objective: - To assess the effect of video based nutrition education targeting poultry value chain on animal source food intake, dietary diversity and nutritional status of 6-23months of children in selected Districts of Konso Zone. Method: - A community based cluster Randomized control trial will be conducted from December 2023- August 2024 in 337 (168 intervention & 168 control) mothers who have children from 6-23 months. A total of 20 clusters will be identified and randomly assigned (10 clusters for intervention and 10 clusters for control), with a total of 16 participants in each small cluster or village. Each household in the intervention clusters mothers who have chickens in their house will receive education using video-based nutrition education on diversified diets, promotion of poultry production, and consumption of eggs. The control group is those who do not have chickens in their homes and will not receive video-based nutrition education. Baseline and end-line outcome measures—anthropometric data, dietary intake, hemoglobin level, and feeding practice—will be assessed. Data will be collected through interviewer-administered questionnaires using an open data kit (ODK) and then exported to STATA version 14 for analysis. Anthropometric data analysis will be done by WHO Anthro v. 3.2.2. Both macro- and micronutrient intakes will be analyzed by the Nutri-Sur
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial description 10/07/2025 editorial issue Background: - Undernutrition in under-five children is not effectively reduced by a single intervention, therefore an emerging framework for improving diet quality involves video based nutrtion education system. Behavior change communication (BCC) is crucial for improving maternal and child nutritional status and adherence to recommended practices during pregnancy, lactation, and early childhood. Video can be used for engagement, empowerment, motivation, and connection among community members. In rural Ethiopia, children's diets are often monotonous, cereal-based, and low in energy and nutrient density. Objective: - To assess the effect of video based nutrition education targeting poultry value chain on animal source food intake, dietary diversity and nutritional status of 6-23months of children in selected Districts of Konso Zone. Method: - A community based cluster Randomized control trial will be conducted from December 2023- August 2024 in 337 (168 intervention & 168 control) mothers who have children from 6-23 months. A total of 20 clusters will be identified and randomly assigned (10 clusters for intervention and 10 clusters for control), with a total of 16 participants in each small cluster or village. Each household in the intervention clusters mothers who have chickens in their house will receive education using video-based nutrition education on diversified diets, promotion of poultry production, and consumption of eggs. The control group is those who do not have chickens in their homes and will not receive video-based nutrition education. Baseline and end-line outcome measures—anthropometric data, dietary intake, hemoglobin level, and feeding practice—will be assessed. Data will be collected through interviewer-administered questionnaires using an open data kit (ODK) and then exported to STATA version 14 for analysis. Anthropometric data analysis will be done by WHO Anthro v. 3.2.2. Both macro- and micronutrient intakes will be analyzed by the Nutri-Sur Background: - Undernutrition in under-five children is not effectively reduced by a single intervention, therefore an emerging framework for improving diet quality involves video based nutrition education system. Behavior change communication (BCC) is crucial for improving maternal and child nutritional status and adherence to recommended practices during pregnancy, lactation, and early childhood. Video can be used for engagement, empowerment, motivation, and connection among community members. In rural Ethiopia, children's diets are often monotonous, cereal-based, and low in energy and nutrient density. Objective: - To assess the effect of video based nutrition education targeting on animal source food consumption, dietary diversity and nutritional status of 6-23months of children in selected Districts of Konso Zone. Method: - A community based cluster Randomized control trial will be conducted from December 2023- August 2024 in 337 (168 intervention & 168 control) mothers who have children from 6-23 months. A total of 20 clusters will be identified and randomly assigned (10 clusters for intervention and 10 clusters for control), with a total of 16 participants in each small cluster or village. Each household in the intervention clusters mothers who have chickens in their house will receive education using video-based nutrition education on diversified diets, promotion of poultry production, and consumption of eggs. The control group is those who do not have chickens in their homes and will not receive video-based nutrition education. Baseline and end-line outcome measures—anthropometric data, dietary intake, hemoglobin level, and feeding practice—will be assessed. Data will be collected through interviewer-administered questionnaires using an open data kit (ODK) and then exported to STATA version 14 for analysis. Anthropometric data analysis will be done by WHO Anthro v. 3.2.2. Both macro- and micronutrient intakes will be analyzed by the Nutri-Sur
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Anticipated trial start date 21/02/2024 Adivsor recommendation 01 Oct 2023 01 Dec 2023
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 21/02/2024 after discussion with the advisor. 01 Oct 2023 01 Dec 2023
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Anticipated date of last follow up 21/02/2024 Adivsor recommendation 30 Apr 2024 01 Mar 2024
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Completion date 21/02/2024 after discussion with the advisor. 30 Dec 2024 30 Aug 2024
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Target no of participants 21/02/2024 Adivsor recommendation 460 337
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Final no of participants 21/02/2024 after discussion with the advisor. 230 168
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Final no of participants 14/07/2025 typing error, in the sample size calculation I have got 337( 168 for intervention and 168 for control) 168 337
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Final no of participants 17/07/2025 In my calculation the total sample size is 337 but I allocate this in to two group equally(168 & 167) so due to odd number just I assigned in to 168 for intervention and 168 for control. Otherwise I will make the control 167 to get the total sample size in both group 337 336
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Final no of participants 18/07/2025 editorial error 336 337
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 14/07/2025 I have recruited all study participants from study site Not yet recruiting Completed
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Inclusion criteria 17/07/2025 editorial error Mothers who had at least one 6-23months children living in the same household in the targeted villages Mothers who had at least one 6-23months children living in the same household in the targeted villages Mothers who had children aged 6-23months children living in the study area.
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Inclusion criteria 08/12/2025 As per request Mothers who had at least one 6-23months children living in the same household in the targeted villages Mothers who had children aged 6-23months children living in the study area. Mothers who had children aged 6-23months children living in the study area.
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Inclusion criteria 19/12/2025 as per request Mothers who had children aged 6-23months children living in the study area. Mothers who had children aged 6-23months children living in the study area. • Age of child 6 -23months • Mothers with children 6-23 months living more than 6 months in study area.
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Exclusion criteria 19/12/2025 as per request Severely ill child and households planning to move out of the study area after base survey. Severely ill child and households planning to move out of the study area after base survey. • Vulnerable groups if the trial isn't designed for them. • History of chronic disease or malnourished children and treatment history for severe acute malnutrition. • Children those have history of treatment and admitted for severe acute malnutrition • Participated in other nutrition intervention. hard to reach and food insecure area
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 21/07/2025 PACTR Admin Infant: 13 Month(s)-24 Month(s) Infant: 13 Month(s)-24 Month(s), Infant: 0 Month(s)-12 Month(s)
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 21/02/2024 Adivsor recommendation Control Group, No Nutrition Intervention, , six month, no, 168, Uncontrolled
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 21/02/2024 Adivsor recommendation Experimental Group, Nutrition intervention, one egg per day and video based education per week, six month, Each households in intervention clusters will receive a gift of two egg laying chickens and mothers will receive education by using video based nutrition education on diversified diet, promotion of poultry production and consumption of egg. , 230, Experimental Group, Nutrition intervention, one egg per day and video based education per week, six month, Each household in the intervention cluster will have egg-laying chickens, and mothers will receive education using video-based nutrition education on a diversified diet, promotion of poultry production, and consumption of eggs. , 168,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 17/07/2025 In my calculation the total sample size is 337 but I allocate this in to two group equally(168 & 167) so due to odd number just I assigned in to 168 for intervention and 168 for control. Otherwise I will make the control 167 to get the total sample size in both group Experimental Group, Nutrition intervention, one egg per day and video based education per week, six month, Each household in the intervention cluster will have egg-laying chickens, and mothers will receive education using video-based nutrition education on a diversified diet, promotion of poultry production, and consumption of eggs. , 168, Experimental Group, Nutrition intervention, one egg per day and video based education per week, six month, Each household in the intervention cluster will have egg-laying chickens, and mothers will receive education using video-based nutrition education on a diversified diet, promotion of poultry production, and consumption of eggs. , 2,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 19/12/2025 as per comments Experimental Group, Nutrition intervention, one egg per day and video based education per week, six month, Each household in the intervention cluster will have egg-laying chickens, and mothers will receive education using video-based nutrition education on a diversified diet, promotion of poultry production, and consumption of eggs. , 2, Experimental Group, Nutrition intervention, one egg per day and video based nutrition education per 2 week, nine month, Each household in the intervention cluster will have egg-laying chickens, and mothers will receive education using video-based nutrition education on a diversified diet, promotion of poultry production, and consumption of eggs. , 2,
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 19/12/2025 as per request Primary Outcome, Nutritional status. , Base line. Primary Outcome, Nutritional status, animal source food consumption and anemia, Base line and endline
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 19/12/2025 as per request Secondary Outcome, Improvement of nutrient intake , End line Secondary Outcome, complementary feeding practice, dietary diversity, End line
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 21/02/2024 After approval FALSE, Hawassa University College of Medicine and Health sciences institutional review board, Hawassa, Hawassa, 1560, Ethiopia, 28 Jul 2023, , +251468209290, hucmhs_ced@hu.edu.et, TRUE, Hawassa University College of Medicine and Health sciences institutional review board, Hawassa, Hawassa, 1560, Ethiopia, 28 Jul 2023, 04 Jan 2024, +251468209290, hucmhs_ced@hu.edu.et, 24378_23187_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 26/08/2024 not approved by yours TRUE, Hawassa University College of Medicine and Health sciences institutional review board, Hawassa, Hawassa, 1560, Ethiopia, , 04 Jan 2024, +251468209290, hucmhs_ced@hu.edu.et, 24378_23187_4737.pdf TRUE, Hawassa University College of Medicine and Health sciences institutional review board, Hawassa, Hawassa, 1560, Ethiopia, , 04 Jan 2024, +251468209290, hucmhs_ced@hu.edu.et, 24378_23187_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 19/12/2025 not approved by yours TRUE, Hawassa University College of Medicine and Health sciences institutional review board, Hawassa, Hawassa, 1560, Ethiopia, , 04 Jan 2024, +251468209290, hucmhs_ced@hu.edu.et, 24378_23187_4737.pdf TRUE, Hawassa University College of Medicine and Health sciences institutional review board, Hawassa, Hawassa, 1560, Ethiopia, , 04 Jan 2024, +251468209290, hucmhs_ced@hu.edu.et, 24378_23187_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 06/03/2023 As per reviewer comment. Hawassa University , Hawassa , Hawassa , 1560 , Ethiopia, University,
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 06/03/2023 As per reviewer comment. Arba Minch University, Arba Minch, Arba Minch, 21, Ethiopia, University,
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 06/03/2023 Based on by reviewer comment Data may be obtained either from study investigators or via data-sharing repositories or platforms. Mothers who have children from 6-23 months.
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 08/03/2023 Based on reviewer's comments Mothers who have children from 6-23 months. Data from this study may be made available to qualified researchers with a focus on human nutrition. Shared information or samples will be encoded. Data sharing with the requesting party is subject to approval of the request and execution of all relevant agreements (such as a material transfer agreement).
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD-Sharing time frame 08/03/2023 Based on reviewer's comments within 12 months of the study completion date. Data requests can be submitted starting 12 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
Section Name Field Name Date Reason Old Value Updated Value
Reporting Key access criteria 08/03/2023 Based on reviewer's comments contact with PI Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).
Section Name Field Name Date Reason Old Value Updated Value
Reporting Results & Publication URL 19/12/2025 to notify no change doi: 10.3389/fnut.2025.1568887