Beta Glucan and Acetate Production

Not Applicable

Completed

• Conditions: Pre Diabetes; Obesity
• Interventions: Dietary Supplement: beta glucan and resistant starch; Dietary Supplement: Placebo; Dietary Supplement: beta gluten

• Registration Number: NCT03714646
• Lead Sponsor: Maastricht University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-06
• Study Start: 2018-09-05
• Status Verified: 2018-10
• Study First Submitted QC: 2018-10-18
• Study First Posted: 2018-10-22
• Primary Completion: 2019-05-10
• Study Completion: 2019-05-10
• Last Update Submitted: 2020-01-10
• Last Update Posted: 2020-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
beta glucan and Resistant Starch	beta glucan and resistant starch	-
Placebo	Placebo	-
beta glucan	beta gluten	-

Primary Outcome Measures

Name	Time	Method
Plasma acetate concentrations (microM)	four hours after a high fat mixed meal

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Maastricht University; 🇳🇱 Maastricht, Limburg, Netherlands