NCT03714646CompletedNot Applicable
The Effects of Beta Glucan on Acetate Production and Human Substrate Metabolism
Maastricht University Medical Center2 sites in 1 country24 target enrollmentStarted: September 5, 2018Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 24
- Locations
- 2
- Primary Endpoint
- Plasma acetate concentrations (microM)
Study Overview
Brief Summary
Based on our hypothesis that orally administered resistant starch and 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: four hours after a high fat mixed meal
Secondary Outcomes
- Energy expenditure (kJ/min) will be measured using an open-circuit ventilated hood system (Omnical, Maastricht University, The Netherlands)(at baseline and four hours after a high fat mixed meal)
- Circulating hormone concentrations (Insulin, GLP-1, PYY)(at baseline and four hours after a high fat mixed meal)
- Breath H2 using (Bedfont EC60 Gastrolyzer, Rochester, UK)(at baseline and four hours after a high fat mixed meal)
- carbohydrate oxidation (g/min) will be measured using an open-circuit ventilated hood system (Omnical, Maastricht University, The Netherlands)(at baseline and four hours after a high fat mixed meal)
- fat oxidation (g/min) will be measured using an open-circuit ventilated hood system (Omnical, Maastricht University, The Netherlands)(at baseline and four hours after a high fat mixed meal)
- Circulating metabolite concentrations (Glucose, Free Fatty Acids, Triglycerides)(at baseline and four hours after a high fat mixed meal)
- Plasma glucose (mmol/L)(at baseline and four hours after a high fat mixed meal)
- Free Fatty Acids (micromol/L)(at baseline and four hours after a high fat mixed meal)
Investigators
Study Sites (2)
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