NCT03711383CompletedNot Applicable
The Effects of Inulin on Acetate Production and Human Substrate Metabolism
Maastricht University Medical Center1 site in 1 country24 target enrollmentStarted: February 20, 2018Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Plasma acetate concentrations (microM)
Study Overview
Brief Summary
Based on our hypothesis that orally administered resistant starch and inulin/beta glucan will be fermented into a SCFA pattern high in acetate and that this will lead to beneficial effects on human substrate and energy metabolism, we aim to address the following primary objective:
To investigate the effects of an acute administration of inulin/beta glucan in combination with resistant starch on fecal and plasma acetate, as well as on fasting and postprandial substrate and energy metabolism in lean normoglycemic men and obese, prediabetic men.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 30 Years to 65 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •lean (BMI ≥ 20kg/m2 and ≤ 24.9kg/m2)
- •normoglycemic
- •aged 30 - 65 years
- •overweight/obese (BMI ≥ 25kg/m2 and ≤ 34.9kg/m2)
- •pre-diabetes
- •aged between 30 - 65 years.
Exclusion Criteria
- •diabetes mellitus
- •gastroenterological diseases or major abdominal surgery (allowed i.e.: - appendectomy, cholecystectomy)
- •lactose intolerance and other digestive disorders
- •cardiovascular disease, cancer, liver or kidney malfunction (determined -based on ALAT and creatinine levels, respectively)
- •disease with a life expectancy shorter than 5 years
- •Use of antibiotics 3 months prior inclusion
- •Use of probiotics or prebiotics
Outcomes
Primary Outcomes
Plasma acetate concentrations (microM)
Time Frame: At baseline and up to four hours after a high-fat mixed meal of each CID
Secondary Outcomes
- Energy expenditure (in kJ/min) using an open-circuit ventilated hood system (Omnical, Maastricht University, The Netherlands)(At baseline and up to four hours after a high-fat mixed meal of each CID)
- Fat oxidation (in g/min) using an open-circuit ventilated hood system (Omnical, Maastricht University, The Netherlands)(At baseline and up to four hours after a high-fat mixed meal of each CID)
- Carbohydrate oxidation (in g/min) using an open-circuit ventilated hood system (Omnical, Maastricht University, The Netherlands)(At baseline and up to four hours after a high-fat mixed meal of each CID)
- Circulating hormone concentrations (Insulin, GLP-1, PYY)(At baseline and up to four hours after a high-fat mixed meal of each CID)
- Circulating metabolite concentrations (Glucose, Free Fatty Acids, Triglycerides)(At baseline and up to four hours after a high-fat mixed meal of each CID)
- Breath H2 using (Bedfont EC60 Gastrolyzer, Rochester, UK)(At baseline and up to four hours after a high-fat mixed meal of each CID)
Investigators
Study Sites (1)
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