Nutritional, Metabolic, Endocrine
Conditions
Interventions
Placebo
Baobab fruit powder
Sponsors
South African Medical Research Council
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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)
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| changes in intestinal permeability using the urinary lactulose/mannitol (Lac/Man) ratio | — |
Secondary
| Measure | Time frame |
|---|---|
| changes in blood biomarkers of intestinal permeability ;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;safety outcomes - liver and kidney markers, gastro-intestinal symptoms | — |
Countries
South Africa
Contacts
Public ContactSylvia Riedel
Specialist Scientist BRIP SAMRC
Outcome results
None listed