Inulin and Acetate Production and Human Substrate Metabolism

The Effects of Inulin on Acetate Production and Human Substrate Metabolism

Based on our hypothesis that orally administered resistant starch and inulin/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: Inulin; Dietary supplement: Inulin and Resistant Starch

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

Contacts and Locations

Study Locations

• Netherlands
  • Maastricht, Netherlands
    • Maastricht University Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• 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 Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; isocaloric maltodextrin the day before CIDs	Dietary supplement: Placebo; isocaloric maltodextrin before test day
Active Comparator: Inulin; 12 g of inulin + isocaloric maltodextrin the day before CID	Dietary supplement: Inulin; 12g per inulin in combination with maltodextrin per day the day before the CID
Experimental: Inulin and Resistant Starch; 12 g inulin + 7.5 g resistant starch the day before CID	Dietary supplement: Inulin and Resistant Starch; 12g per inulin in combination 7.5 g resistant starch 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 and up to four hours after a high-fat mixed meal of each CID

Secondary Outcome Measures

Outcome Measure	Time Frame
Energy expenditure (in kJ/min) using an open-circuit ventilated hood system (Omnical, Maastricht University, The Netherlands)	At baseline and up to four hours after a high-fat mixed meal of each CID
Fat oxidation (in g/min) using an open-circuit ventilated hood system (Omnical, Maastricht University, The Netherlands)	At baseline and up to four hours after a high-fat mixed meal of each CID
Carbohydrate oxidation (in g/min) using an open-circuit ventilated hood system (Omnical, Maastricht University, The Netherlands)	At baseline and up to four hours after a high-fat mixed meal of each CID
Circulating hormone concentrations (Insulin, GLP-1, PYY)	At baseline and up to four hours after a high-fat mixed meal of each CID
Circulating metabolite concentrations (Glucose, Free Fatty Acids, Triglycerides)	At baseline and up to four hours after a high-fat mixed meal of each CID
Breath H2 using (Bedfont EC60 Gastrolyzer, Rochester, UK)	At baseline and up to four hours after a high-fat mixed meal of each CID

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): February 20, 2018
• Primary Completion (Actual): November 15, 2018
• Study Completion (Actual): November 15, 2018

Study Registration Dates

• First Submitted: July 6, 2018
• First Submitted That Met QC Criteria: October 16, 2018
• First Posted (Actual): October 18, 2018

Study Record Updates

• Last Update Posted (Actual): January 14, 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: NL63754.068.17

Drug and device information, study documents

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