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 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202308727853680 Date of Approval: 08/08/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effects of Baobab fruit powder on gut and cardiometabolic health in obesity – a randomised placebo-controlled trial
Official scientific title Effects of Baobab fruit powder on gut and cardiometabolic health in obesity – a randomised placebo-controlled trial
Brief summary describing the background and objectives of the trial Baobab fruit powder (BFP) is a commercially available product that has been consumed in Africa for centuries and is known to contain high levels of fibre and vitamin C. Dietary fibre is a key component of a healthy diet and plays a vital role in the protection of the intestinal barrier, for instance by shaping gut bacteria composition and diversity. Increased intestinal permeability allows bacterial products, such as lipopolysaccharide (LPS), into the systemic circulation inducing chronic low-grade inflammation. Based on the high fibre content of BFP we hypothesize BFP will decrease intestinal permeability, increase intestinal microbial diversity and subsequently lead to improvements in cardiometabolic risk factors. Aim: Using a randomised double-blind placebo-controlled trial, we aim to examine the effects of consumption of BFP on intestinal permeability and cardiometabolic risk factors in participants with obesity. In addition, the safety of BFP in humans will also be assessed. To achieve this aim, we will measure the following changes in response to the 45-day BFP intervention compared to the control group: • changes in intestinal permeability using the urinary lactulose/mannitol (Lac/Man) ratio (primary outcome) • changes in blood biomarkers of intestinal permeability (secondary outcomes) • changes in the composition and diversity of gut bacterial profiles (secondary outcome) • changes in cardiometabolic risk markers including anthropometric measurements (such as body mass index (BMI), waist and hip circumference), blood lipid profiles, fasting glycaemia, insulin resistance, inflammation and blood pressure (secondary outcomes) • changes in liver (aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase (ALP), gamma glutamyl transpeptidase (GGT)) and kidney (creatinine) function, and gastro-intestinal symptoms (safety outcomes)
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 Physical activity and nutrition
Anticipated trial start date 17/06/2024
Actual trial start date
Anticipated date of last follow up 31/12/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
SAMRC Human Research Ethics Committee
UCT Human Research Ethics Committee
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
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Placebo 13.5 g, daily 45 days The placebo will contain tapioca flour and citric acid, which will have a similar appearance, taste and caloric content as baobab fruit powder. 25 Placebo
Experimental Group Baobab fruit powder 16 g, daily 45 days The Baobab Fruit powder (BFP) used for this study is derived from Baobab fruit. To produce the BFP, the hard shell of baobab fruits is opened and the seeds are separated from the fruit powder. The fruit powder is further milled, sieved and packaged in a facility that is certified according to FSSC 22000 version 5, which is a Food Safety System Certification. The BFP is certified organic according to European Union and United States Department of Agriculture standards. Batches of BFP are regularly tested according to standard specifications by an accredited testing laboratory including testing for microbial, pesticide and heavy metal contaminants. 25
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Ability to sign informed consent • Age between 30 and 45 years • BMI ≥ 30 kg/m2 • Weight stable (less than 5 kg weight change in the last 6 months) History of gastrointestinal diseases (e.g. irritable bowel syndrome, coeliac disease, Crohn’s disease, Ulcerative Colitis) and gastrointestinal surgery Current smoker (including e-cigarettes) or user of chewing tobacco Current bacterial or viral infection Pregnancy or breastfeeding Regular use of chronic medication (prescription medication for obesity, chronic non-communicable and infectious diseases, immunosuppressants, frequent use of over-the-counter drugs such as non-steroidal anti-inflammatory drugs and laxatives) Known chronic diseases (with or without treatment with prescription medication) or screen-detected diseases, e.g.: -> autoimmune diseases -> hypertension (BP >140/90 mm Hg); -> Type 1 or Type 2 diabetes (FBG > 7 mmol/l) -> dyslipidaemia (TG >1.7 mmol/l, LDL > 3.0 mmol/l) -> reproductive diseases (e.g. endometriosis or polycystic ovary syndrome) -> thyroid diseases Allergies, e.g. known allergy to baobab (Martini et al., 2019), and food intolerances (e.g. sugar alcohol intolerance) Oral antibiotic use, fibre, pre- and/or probiotic supplement use in the preceding 3 months Adult: 19 Year-44 Year 30 Year(s) 45 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 30/04/2024 SAMRC HREC
Ethics Committee Address
Street address City Postal code Country
Francie van Zijl Drive Tygerberg 7505 South Africa
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 12/12/2023 HREC UCT
Ethics Committee Address
Street address City Postal code Country
Room E52-24 Groote Schuur Hospital, Old Main Building, Observatory Cape Town 7925 South Africa
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 22/12/2023 South African Health Products Regulatory Authority SAHPRA
Ethics Committee Address
Street address City Postal code Country
Meiring Naude Road, Building 38a Pretoria 0083 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome changes in intestinal permeability using the urinary lactulose/mannitol (Lac/Man) ratio pre- and post-intervention
Secondary Outcome changes in blood biomarkers of intestinal permeability pre- and post-intervention
Secondary Outcome changes in the composition and diversity of gut microbiota profile pre- and post-intervention
Secondary Outcome changes in cardiometabolic risk markers including anthropometric measurements (such as body mass index (BMI), waist and hip circumference), blood lipid profiles, fasting glycaemia, insulin resistance, inflammation and blood pressure pre- and post-intervention
Secondary Outcome safety outcomes - liver and kidney markers, gastro-intestinal symptoms pre-intervention, following 14 days of intervention, post-intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
HPALS SSISA Boundary Road, Newlands Cape Town South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
German Development Cooperation Gesellschaft fuer Internationale Zusammenarbeit GIZ Friedrich-Ebert-Allee 36 - 40 Bonn 53113 Germany
South African Medical Research Council Francie van Zijl Drive Cape Town 7500 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor South African Medical Research Council Francie van Zijl Drive Parow Valley 7500 South Africa Parastatal Research Institution
Primary Sponsor University of Cape Town Boundary Road Cape Town 7700 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Julia Goedecke Francie van Zijl Drive Cape Town 7500 South Africa
Amy Mendham 10 Maddern Avenue Berri SA 5343 Australia
Pieter Venter Francie van Zijl Drive Cape Town 7500 South Africa
Joel Dave Groote Schuur Hospital Cape Town 7700 South Africa
Lara Dugas Boundary Road Cape Town 7700 South Africa
Carmen Pheiffer Francie van Zijl Drive Cape Town 7500 South Africa
Rabia Johnson Francie van Zijl Drive Cape Town 7500 South Africa
Tarylee Reddy Peter Mokaba Ridge Durban 4091 South Africa
Christo Muller Francie van Zijl Drive Cape Town 7500 South Africa
Dr Caroline DAlton Boundary Road Cape Town 7700 South Africa
Dr Nonhlanhla Yende Zuma Peter Mokaba Ridge Durban 4091 South Africa
Dr Keren de Buys Francie van Zijl Drive Cape Town 7500 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Joel Dave joeldave@endocrine.co.za +27214045007 Old Main Building, Groote Schuur Hospital
City Postal code Country Position/Affiliation
Cape Town 7925 South Africa Head of Division of Endocrinology UCT
Role Name Email Phone Street address
Public Enquiries Sylvia Riedel sylvia.riedel@mrc.ac.za +27219380844 Francie van Zijl Drive
City Postal code Country Position/Affiliation
Cape Town 7500 South Africa Specialist Scientist BRIP SAMRC
Role Name Email Phone Street address
Scientific Enquiries Julia Goedecke julia.goedecke@mrc.ac.za +27219380862 Francie van Zijl Drive
City Postal code Country Position/Affiliation
Cape Town 7500 South Africa Chief Specialist Scientist BRIP SAMRC
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in the publication, after de-identification (text, tables, figures, and appendices). Study Protocol Immediately after publication, no end date Study participants may request the results that will be published after de-identification. Investigators whose proposed use of the data has been approved by an independent review committee (“learned intermediary”) identified for this purpose. After being granted permission by the review committee, external users will be required to complete data transfer agreements and contracts with the project partners. Once published (including pre-print), data will be immediately available for sharing. Unpublished data will be shared 3 years after the completion of the grant period. The data will be made available in an appropriate repository, e.g. Figshare (https://figshare.com/ ).
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