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Beta Glucan and Acetate Production

Primary Purpose

Pre Diabetes, Obesity

Status

Completed

Phase

Not Applicable

Locations

Netherlands

Study Type

Interventional

Intervention

beta glucan and resistant starch

Placebo

beta gluten

About this trial

This is an interventional basic science trial for Pre Diabetes

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

Maastricht University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Experimental

Arm Label

Placebo

beta glucan

beta glucan and Resistant Starch

Arm Description

Outcomes

Primary Outcome Measures

Plasma acetate concentrations (microM)

Secondary Outcome Measures

Energy expenditure (kJ/min) will be measured using an open-circuit ventilated hood system (Omnical, Maastricht University, The Netherlands)

fat oxidation (g/min) will be measured using an open-circuit ventilated hood system (Omnical, Maastricht University, The Netherlands)

carbohydrate oxidation (g/min) will be measured using an open-circuit ventilated hood system (Omnical, Maastricht University, The Netherlands)

Circulating hormone concentrations (Insulin, GLP-1, PYY)

Circulating metabolite concentrations (Glucose, Free Fatty Acids, Triglycerides)

Plasma glucose (mmol/L)

Free Fatty Acids (micromol/L)

Breath H2 using (Bedfont EC60 Gastrolyzer, Rochester, UK)

Full Information

NCT ID

NCT03714646

First Posted

July 6, 2018

Last Updated

January 10, 2020

Sponsor

Maastricht University Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT03714646

Brief Title

Beta Glucan and Acetate Production

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Completed

Study Start Date

September 5, 2018 (Actual)

Primary Completion Date

May 10, 2019 (Actual)

Study Completion Date

May 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Maastricht University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pre Diabetes, Obesity

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Title

beta glucan

Arm Type

Active Comparator

Arm Title

beta glucan and Resistant Starch

Arm Type

Experimental

Intervention Type

Dietary Supplement

Intervention Name(s)

beta glucan and resistant starch

Intervention Description

12g per day the day before the CID Resistant starch 7.5 g

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

isocaloric maltodextrin before the CID

Intervention Type

Dietary Supplement

Intervention Name(s)

beta gluten

Intervention Description

12 g beta gluten there day before the CID

Primary Outcome Measure Information:

Title

Plasma acetate concentrations (microM)

Time Frame

at baseline (before a high-fat mixed meal)

Title

Plasma acetate concentrations (microM)

Time Frame

four hours after a high fat mixed meal

Secondary Outcome Measure Information:

Title

Energy expenditure (kJ/min) will be measured using an open-circuit ventilated hood system (Omnical, Maastricht University, The Netherlands)

Time Frame