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Inulin and Acetate Production and Human Substrate Metabolism

Primary Purpose

Obesity, Pre Diabetes

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Inulin and Resistant Starch
Inulin
Placebo
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obesity

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

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

Sites / Locations

  • Maastricht University Medical Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Experimental

Arm Label

Placebo

Inulin

Inulin and Resistant Starch

Arm Description

isocaloric maltodextrin the day before CIDs

12 g of inulin + isocaloric maltodextrin the day before CID

12 g inulin + 7.5 g resistant starch the day before CID

Outcomes

Primary Outcome Measures

Plasma acetate concentrations (microM)

Secondary Outcome Measures

Energy expenditure (in kJ/min) using an open-circuit ventilated hood system (Omnical, Maastricht University, The Netherlands)
Fat oxidation (in g/min) using an open-circuit ventilated hood system (Omnical, Maastricht University, The Netherlands)
Carbohydrate oxidation (in g/min) 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)
Breath H2 using (Bedfont EC60 Gastrolyzer, Rochester, UK)

Full Information

First Posted
July 6, 2018
Last Updated
January 10, 2020
Sponsor
Maastricht University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03711383
Brief Title
Inulin and Acetate Production and Human Substrate Metabolism
Official Title
The Effects of Inulin 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
February 20, 2018 (Actual)
Primary Completion Date
November 15, 2018 (Actual)
Study Completion Date
November 15, 2018 (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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

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

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 Description
isocaloric maltodextrin the day before CIDs
Arm Title
Inulin
Arm Type
Active Comparator
Arm Description
12 g of inulin + isocaloric maltodextrin the day before CID
Arm Title
Inulin and Resistant Starch
Arm Type
Experimental
Arm Description
12 g inulin + 7.5 g resistant starch the day before CID
Intervention Type
Dietary Supplement
Intervention Name(s)
Inulin and Resistant Starch
Intervention Description
12g per inulin in combination 7.5 g resistant starch per day the day before the CID Resistant starch 7.5 g
Intervention Type
Dietary Supplement
Intervention Name(s)
Inulin
Intervention Description
12g per inulin in combination with maltodextrin per day the day before the CID
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
isocaloric maltodextrin before test day
Primary Outcome Measure Information:
Title
Plasma acetate concentrations (microM)
Time Frame
At baseline and up to four hours after a high-fat mixed meal of each CID
Secondary Outcome Measure Information:
Title
Energy expenditure (in kJ/min) using an open-circuit ventilated hood system (Omnical, Maastricht University, The Netherlands)
Time Frame
At baseline and up to four hours after a high-fat mixed meal of each CID
Title
Fat oxidation (in g/min) using an open-circuit ventilated hood system (Omnical, Maastricht University, The Netherlands)
Time Frame
At baseline and up to four hours after a high-fat mixed meal of each CID
Title
Carbohydrate oxidation (in g/min) using an open-circuit ventilated hood system (Omnical, Maastricht University, The Netherlands)
Time Frame
At baseline and up to four hours after a high-fat mixed meal of each CID
Title
Circulating hormone concentrations (Insulin, GLP-1, PYY)
Time Frame
At baseline and up to four hours after a high-fat mixed meal of each CID
Title
Circulating metabolite concentrations (Glucose, Free Fatty Acids, Triglycerides)
Time Frame
At baseline and up to four hours after a high-fat mixed meal of each CID
Title
Breath H2 using (Bedfont EC60 Gastrolyzer, Rochester, UK)
Time Frame
At baseline and up to four hours after a high-fat mixed meal of each CID

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Maastricht University Medical Centre
City
Maastricht
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
34923911
Citation
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.
Results Reference
derived

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Inulin and Acetate Production and Human Substrate Metabolism

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