Trial no.:	PACTR202607499297370	Date of Registration:	06/07/2026
Trial Status:	Registered in accordance with WHO and ICMJE standards

TRIAL DESCRIPTION

Public title

Glyceamic Response and Satiety Effect Associated with White Bread Intake and Co-Consumption of Cocoa Beverages

Official scientific title

Glyceamic Response and Satiety Effect Associated with White Bread Intake and Co-Consumption of Cocoa Beverages

Brief summary describing the background and objectives of the trial

The prevalence of overweight, obesity and type 2 diabetes mellitus continues to increase globally and within Ghana, contributing substantially to morbidity, mortality and healthcare expenditure. Persistent postprandial hyperglycaemia has been implicated in the development and progression of insulin resistance, obesity, cardiovascular diseases and type 2 diabetes mellitus. Although dietary modification remains one of the most effective approaches for preventing and managing metabolic disorders, long-term adherence to restrictive dietary interventions is often poor due to cultural preferences, affordability and accessibility challenges. Consequently, there is a growing need for practical, culturally acceptable and sustainable dietary strategies capable of improving glycaemic regulation without requiring complete elimination of commonly consumed staple foods. Cocoa products are widely available and culturally accepted in Ghana, and cocoa is known to contain polyphenolic compounds with potential anti-diabetic, antioxidant and satiety-enhancing properties. Despite these promising attributes, limited studies have investigated the acute effects of cocoa beverage co-consumption with high glycaemic foods such as white bread on postprandial glycaemic response and satiety. Also, previous studies have rarely compared the metabolic effects of cocoa beverage co-consumption across distinct physiological and clinical populations such as healthy adults, overweight or obese adults, older adults with or without diabetes. Main Objective To investigate and compare the glycaemic and satiety effects associated with white bread intake and co-consumption of cocoa beverage among healthy young adults, overweight or obese young adults, older adults without diabetes and older adults with diabetes over a 120-minute postprandial period.

Type of trial

RCT

Acronym (If the trial has an acronym then please provide)

Disease(s) or condition(s) being studied

Circulatory System,Digestive System,Nutritional, Metabolic, Endocrine

Sub-Disease(s) or condition(s) being studied

Purpose of the trial

Physical activity and nutrition

Anticipated trial start date

22/06/2026

Actual trial start date

Anticipated date of last follow up

31/07/2026

Actual Last follow-up date

Anticipated target sample size (number of participants)

60

Actual target sample size (number of participants)

Recruitment status

Not yet recruiting

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
Crossover: all participants receive all interventions in different sequence during study	Randomised	Simple randomization using a randomization table created by a computer software program	Sealed opaque envelopes	Open-label(Masking Not Used)

INTERVENTIONS
Intervention type	Intervention name	Dose	Duration	Intervention description	Group size	Nature of control
Control Group	White bread with water	Bread serve equivalent to 50g of available carbohydrates, with 250 ml of water	2 hours of digestion of white bread	Participants will be allowed to fast overnight (10 hours). The test meal will be made to contain 50 g of available carbohydrates from white bread and 250 ml of water. On the test day, participants will be allowed to rest for 5 minutes. Baseline blood pressure and capillary blood glucose sample will be taken at -5 and 0 minutes. Participants will consume the control test meal within 12 minutes, along with 250ml of water. Postprandial capillary blood glucose will be taken at the time points 15, 30, 45, 60, 90,120 minutes. At each time point, satiety assessment will be taken.	15	Dose Comparison
Experimental Group	White bread and cocoa beverage	1. Bread serving of 50g of available carbohydrates and 15g cocoa powder in 250mL water with 26.8mL (29g) diary creamer 2. Bread serving of 50g of available carbohydrates and 15g of cocoa powder in 250ml of water 3. Bread serving of 50g of available carbohydrates and 26.8mL (29g) of diary creamer in 250mL water	1. 2 hours digestion of white bread and cocoa and milk beverage 2. 2 hours digestion of white bread and cocoa beverage 3. 2 hours digestion of whites bread and milk beverage	Participants will be allowed to fast overnight (10 hours). Each test meal will be made to contain 50g of available carbohydrates from white bread and the different beverages. On each test day, participants will be allowed to rest for 5 minutes. Baseline blood pressure and capillary blood glucose sample will be taken at -5 and 0 minutes. Participants will consume the control test meal within 12 minutes, along with the different servings of the beverage. Postprandial capillary blood glucose will be taken at the time points 15, 30, 45, 60, 90,120 minutes. At each time point, satiety assessment will be taken.	15

ELIGIBILITY CRITERIA
List inclusion criteria	List exclusion criteria	Age Category	Minimum age	Maximum age	Gender
Phase 1. Individuals who are overweight or obese young adults aged 18–35 years with a BMI ≥25 kg/m² Phase 2. Older adults without diabetes aged 50 years and above with a normal fasting blood glucose levels and no prior diagnosis of diabetes mellitus Phase 3.Healthy young adults aged 18–35 years with a BMI between 18.5–24.9 kg/m² and a normal fasting blood glucose levels Phase 4. Older adults with diabetes aged 50 years and above who are physician-diagnosed type 2 diabetes mellitus, with a stable glycaemic control and are on a stable oral hypoglycaemic medications	Participants will be excluded if they: • are intolerant or allergic to cocoa, gluten, milk or dairy products; • are pregnant or lactating; • have gastrointestinal disorders, dysphagia or chronic inflammatory diseases; • are insulin-dependent people with diabetes; • have severe diabetic complications; • are taking medications known to interfere with glucose metabolism; • are heavy alcohol consumers or smokers; • engage in excessive vigorous physical activity; • or fail to comply with study instructions.	Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s)	18 Year(s)	70 Year(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

15/06/2026

Committee on Human Research Publication and Ethics

Ethics Committee Address
Street address	City	Postal code	Country
Room 7, Block L, School of Medicine and Dentistry, Kwame Nkrumah University of Science and Technology, Kumasi, Ghana	Kumasi	AOK384	Ghana

OUTCOMES
Type of outcome	Outcome	Timepoint(s) at which outcome measured
Primary Outcome	Change in capillary blood glucose	baseline at -5 and 0min, and postprandial at 15, 30, 45, 60, 90 and 120min
Secondary Outcome	Change in satiety	baseline at -5 and 0min, and postprandial at 15, 30, 45, 60, 90 and 120min
Secondary Outcome	Change in systolic and diastolic blood pressure	baseline at -5 and 0min, and postprandial at 15, 30, 45, 60, 90 and 120min

RECRUITMENT CENTRES
Name of recruitment centre	Street address	City	Postal code	Country
Department of Biochemistry and Biotechnology	Department of Biochemistry and Biotechnology, College of Science, Kwame Nkrumah University of Science and Technology, Kumasi, Ghana	Kumasi		Ghana

FUNDING SOURCES
Name of source	Street address	City	Postal code	Country
Vanessa Adu Sarpong	Department of Biochemistry and Biotechnology, College of Science, Kwame Nkrumah University of Science and Technology, Kumasi, Ghana	Kumasi		Ghana
Emmanuel Derrick Osei Tutu	Department of Biochemistry and Biotechnology, College of Science, Kwame Nkrumah University of Science and Technology, Kumasi, Ghana	Kumasi		Ghana
Faustina Afi Atakora	Department of Biochemistry and Biotechnology, College of Science, Kwame Nkrumah University of Science and Technology, Kumasi, Ghana	Kumasi		Ghana

SPONSORS
Sponsor level	Name	Street address	City	Postal code	Country	Nature of sponsor
Primary Sponsor	Kwame Nkrumah University of Science and Technology	Department of Biochemistry and Biotechnology, College of Science, Kwame Nkrumah University of Science and Technology, Kumasi, Ghana	Kumasi		Ghana	University

COLLABORATORS
Name	Street address	City	Postal code	Country

CONTACT PEOPLE
Role	Name	Email	Phone	Street address
Principal Investigator	Vanessa Adu Sarpong	vadusarpong@gmail.com	+233556797591	Department of Biochemistry and Biotechnology, College of Science, Kwame Nkrumah University of Science and Technology, Kumasi, Ghana
City	Postal code	Country	Position/Affiliation
Kumasi		Ghana	Investigator
Role	Name	Email	Phone	Street address
Scientific Enquiries	Isaac Amoah	isaacamoah456@gmail.com	+233249183185	Department of Biochemistry and Biotechnology, College of Science, Kwame Nkrumah University of Science and Technology, Kumasi, Ghana
City	Postal code	Country	Position/Affiliation
Kumasi		Ghana	Supervisor
Role	Name	Email	Phone	Street address
Public Enquiries	Faustina Afi Atakora	faustinayaababy@gmail.com	+233594523192	Department of Biochemistry and Biotechnology, College of Science, Kwame Nkrumah University of Science and Technology
City	Postal code	Country	Position/Affiliation
Kumasi		Ghana	Investigator
Role	Name	Email	Phone	Street address
Public Enquiries	Derrick Osei Tutu	oseitutuderrick02@gmail.com	+233536901086	Department of Biochemistry and Biotechnology, College of Science, Kwame Nkrumah University of Science and Technology
City	Postal code	Country	Position/Affiliation
Kumasi		Ghana	Investigator

REPORTING
Share IPD	Description	Additional Document Types	Sharing Time Frame	Key Access Criteria
Yes	A summary of the study finding will be reported in the form of manuscript for publication as a journal article. Individual participant data (IPD) will be filed and protected under lock and information from individual participant will be treated as highly confidential. IPD will be retained on an external hard drive and kept 5 years after the study. IPD will be made accessible to Committee on Human Research, Publication and Ethics (CHRPE) and the Principal investigators (PIs). Other research staff will have controlled access to the data. All data obtained through the study will be the property of the investigators and at no point will such data be released without the approval of PIs and ethical and regulatory bodies concerned.	Clinical Study Report,Informed Consent Form,Study Protocol	IPD will be retained on an external hard drive and kept 5 years after the study. IPD will be made accessible to Committee on Human Research, Publication and Ethics (CHRPE) and the Principal investigators (PIs). Other research staff will have controlled access to the data. All data obtained through the study will be the property of the investigators and at no point will such data be released without the approval of PIs and ethical and regulatory bodies concerned.	Researchers and reviewers may request access to the de-identified IPD for the purposes of their own data analysis. The quality of proposal and the qualification of requestors will be reviewed and approved on a case-by-case basis at the discretion of the Principal Investigators and the primary sponsor, with a requirement to sign data access agreement.
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	Trial description	27/06/2026	i had to update the background of the study with the the objectives.	The prevalence of overweight, obesity and type 2 diabetes mellitus continues to increase globally and within Ghana, contributing substantially to morbidity, mortality and healthcare expenditure. Dietary patterns characterized by high consumption of refined carbohydrate foods such as white bread significantly contribute to exaggerated postprandial glycaemic responses, impaired satiety regulation and increased metabolic risk. Persistent postprandial hyperglycaemia has been implicated in the development and progression of insulin resistance, obesity, cardiovascular diseases and type 2 diabetes mellitus (Hiyoshi et al., 2017; Wondmkun, 2020). Although dietary modification remains one of the most effective approaches for preventing and managing metabolic disorders, long-term adherence to restrictive dietary interventions is often poor due to cultural preferences, affordability and accessibility challenges. Consequently, there is a growing need for practical, culturally acceptable and sustainable dietary strategies capable of improving glycaemic regulation without requiring complete elimination of commonly consumed staple foods. Cocoa products are widely available and culturally accepted in Ghana, and cocoa is known to contain polyphenolic compounds with potential anti-diabetic, antioxidant and satiety-enhancing properties. Despite these promising attributes, limited studies have investigated the acute effects of cocoa beverage co-consumption with high glycaemic foods such as white bread on postprandial glycaemic response and satiety. Existing evidence has largely focused on non-African populations and healthy individuals, thereby limiting contextual applicability to Ghanaian populations with varying metabolic characteristics. Also, previous studies have rarely compared the metabolic effects of cocoa beverage co-consumption across distinct physiological and clinical populations such as healthy adults, overweight or obese adults, older adults with or without diabetes.	The prevalence of overweight, obesity and type 2 diabetes mellitus continues to increase globally and within Ghana, contributing substantially to morbidity, mortality and healthcare expenditure. Persistent postprandial hyperglycaemia has been implicated in the development and progression of insulin resistance, obesity, cardiovascular diseases and type 2 diabetes mellitus. Although dietary modification remains one of the most effective approaches for preventing and managing metabolic disorders, long-term adherence to restrictive dietary interventions is often poor due to cultural preferences, affordability and accessibility challenges. Consequently, there is a growing need for practical, culturally acceptable and sustainable dietary strategies capable of improving glycaemic regulation without requiring complete elimination of commonly consumed staple foods. Cocoa products are widely available and culturally accepted in Ghana, and cocoa is known to contain polyphenolic compounds with potential anti-diabetic, antioxidant and satiety-enhancing properties. Despite these promising attributes, limited studies have investigated the acute effects of cocoa beverage co-consumption with high glycaemic foods such as white bread on postprandial glycaemic response and satiety. Also, previous studies have rarely compared the metabolic effects of cocoa beverage co-consumption across distinct physiological and clinical populations such as healthy adults, overweight or obese adults, older adults with or without diabetes. Main Objective To investigate and compare the glycaemic and satiety effects associated with white bread intake and co-consumption of cocoa beverage among healthy young adults, overweight or obese young adults, older adults without diabetes and older adults with diabetes over a 120-minute postprandial period.

Pan African Clinical Trials Registry