Beta Glucan and Acetate Production

Obesity Clinical Trial

Official title:

The Effects of Beta Glucan on Acetate Production and Human Substrate Metabolism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03714646
• Other study ID #: NL63759.068.17
• Status: Completed
• Phase: N/A
• Start date: September 5, 2018
• Est. completion date: May 10, 2019

Study information

• Verified date: October 2018
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Obesity
• Pre Diabetes
• Prediabetic State

Intervention

Dietary Supplement:
• beta glucan and resistant starch
12g per day the day before the CID Resistant starch 7.5 g
• Placebo
isocaloric maltodextrin before the CID
• beta gluten
12 g beta gluten there day before the CID

Locations

Country	Name	City	State
Netherlands	Maastricht University	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

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