Effects of Baobab fruit powder on gut and cardiometabolic health in obesity – a randomised placebo-controlled trial
- Conditions
- Nutritional, Metabolic, Endocrine
- Registration Number
- PACTR202308727853680
- Lead Sponsor
- South African Medical Research Council
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 50
•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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method changes in intestinal permeability using the urinary lactulose/mannitol (Lac/Man) ratio
- Secondary Outcome Measures
Name Time Method changes in blood biomarkers of intestinal permeability<br><br>;changes in the composition and diversity of gut microbiota profile;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