Obesity Clinical Trial
Official title:
The Effects of Beta Glucan on Acetate Production and Human Substrate Metabolism
Verified date | October 2018 |
Source | Maastricht University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 24 |
Est. completion date | May 10, 2019 |
Est. primary completion date | May 10, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 30 Years to 65 Years |
Eligibility |
Inclusion Criteria: - lean (BMI = 20kg/m2 and = 24.9kg/m2) - normoglycemic - aged 30 - 65 years OR - 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 |
Country | Name | City | State |
---|---|---|---|
Netherlands | Maastricht University | Maastricht | Limburg |
Lead Sponsor | Collaborator |
---|---|
Maastricht University Medical Center |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Plasma acetate concentrations (microM) | at baseline (before a high-fat mixed meal) | ||
Primary | Plasma acetate concentrations (microM) | four hours after a high fat mixed meal | ||
Secondary | 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 | ||
Secondary | 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 | ||
Secondary | 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 | ||
Secondary | Circulating hormone concentrations (Insulin, GLP-1, PYY) | at baseline and four hours after a high fat mixed meal | ||
Secondary | Circulating metabolite concentrations (Glucose, Free Fatty Acids, Triglycerides) | at baseline and four hours after a high fat mixed meal | ||
Secondary | Plasma glucose (mmol/L) | at baseline and four hours after a high fat mixed meal | ||
Secondary | Free Fatty Acids (micromol/L) | at baseline and four hours after a high fat mixed meal | ||
Secondary | Breath H2 using (Bedfont EC60 Gastrolyzer, Rochester, UK) | at baseline and four hours after a high fat mixed meal |
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