Beta Glucan and Acetate Production

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

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 Overview

• Status: Completed
• Conditions: Obesity; Pre Diabetes
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: beta gluten; Dietary supplement: beta glucan and resistant starch

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Limburg
    • Maastricht, Limburg, Netherlands, 5229 ER
      • Maastricht University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Dietary supplement: Placebo; isocaloric maltodextrin before the CID
ACTIVE_COMPARATOR: beta glucan	Dietary supplement: beta gluten; 12 g beta gluten there day before the CID
EXPERIMENTAL: beta glucan and Resistant Starch	Dietary supplement: beta glucan and resistant starch; 12g per day the day before the CID Resistant starch 7.5 g

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Plasma acetate concentrations (microM)	at baseline (before a high-fat mixed meal)
Plasma acetate concentrations (microM)	four hours after a high fat mixed meal

Secondary Outcome Measures

Outcome Measure	Time Frame
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
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
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
Circulating hormone concentrations (Insulin, GLP-1, PYY)	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
Breath H2 using (Bedfont EC60 Gastrolyzer, Rochester, UK)	at baseline and four hours after a high fat mixed meal

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center

Publications and helpful links

General Publications

• Canfora EE, Hermes GDA, Muller M, Bastings J, Vaughan EE, van Den Berg MA, Holst JJ, Venema K, Zoetendal EG, Blaak EE. Fiber mixture-specific effect on distal colonic fermentation and metabolic health in lean but not in prediabetic men. Gut Microbes. 2022 Jan-Dec;14(1):2009297. doi: 10.1080/19490976.2021.2009297.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 5, 2018
• Primary Completion (ACTUAL): May 10, 2019
• Study Completion (ACTUAL): May 10, 2019

Study Registration Dates

• First Submitted: July 6, 2018
• First Submitted That Met QC Criteria: October 18, 2018
• First Posted (ACTUAL): October 22, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 13, 2020
• Last Update Submitted That Met QC Criteria: January 10, 2020
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Prediabetic State
• Other Study ID Numbers: NL63759.068.17

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No