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Acute Microbial Switch

Primary Purpose

Insulin Sensitivity, Glucose Metabolism Disorders (Including Diabetes Mellitus), Hyperinsulinism

Status
Not yet recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Two day supplementation of a complex fiber mixture
Placebo supplementation
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Insulin Sensitivity focused on measuring microbiota, insulin sensitivity, fiber

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Lean normoglycemic individuals: Lean (BMI ≥ 18.5 kg/m2 and ≤ 24.9 kg/m2 ); Normal fasting glucose (plasma glucose < 5.6 mmol/L) and a HOMA-IR< 2.2 Individuals with overweight/obesity and prediabetes/insulin resistance: Overweight/obesity (BMI ≥ 28 kg/m2 and ≤ 40 kg/m2 ); insulin resistance (HOMA-IR>2.2) and/or impaired fasting glucose (IFG: plasma glucose ≥ 5.6 mmol/l) For both subject groups: Aged 30 - 75 years; Normal blood pressure (systolic blood pressure 100-150mmHg, diastolic blood pressure 60-100 mmHg); Weight stable for at least 3 months (± 2 kg) Exclusion Criteria: T2DM (defined as fasting plasma glucose ≥ 7.0 mmol/L) Gastroenterological diseases Abdominal surgery affecting the GI tract; Cardiovascular diseases, cancer, liver or kidney malfunction, disease with a life expectancy shorter than five years; Abuse of products; Alcohol (> 15 standard units per week) Drugs Excessive nicotine use defined as >20 cigarettes per day; Plans to lose weight or following of a hypocaloric diet Regular supplementation of pre- or probiotic products, use of pre- or probiotics three months prior to the start of the study; Intensive exercise training more than three hours a week; Use of most medications that influence glucose or fat metabolism, like some lipid lowering-drugs (e.g., PPAR γ or PPARα (fibrates) agonists), glucose-lowering agents (including all sulfonylureas, biguanides, α-glucosidase inhibitors, thiazolidinediones, repaglinide, nateglinide and insulin), inflammation (e.g., anti-inflammatory* or immunosuppressive drugs) and anti-oxidants; Regular use of laxatives; Use of antibiotics in the last three months (antibiotics use can alter substantially the gut microbiota composition). Veganism Lactose intolerance For women: pregnancy or lactation

Sites / Locations

  • Department of Human Biology, Maastricht University Medical Centre
  • Maastricht University Medical Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Placebo Comparator

Arm Label

lean normoglycaemic individuals fiber mixture

lean normoglycaemic placebo

overweight and/or obesity and prediabetes/insulin fiber mixture

overweight and/or obesity and prediabetes/insulin resistance placebo

Arm Description

Two day supplementation of 12 g (3 x 4 g) of the dietary fiber inulin in combination with 9.375 g (3 x 3.125 g (80% resistant starch (3 x 2.5 g)) granular potato starch

Two day supplementation of 11.43 g (3 x 3.81 g) maltodextrin

Two day supplementation of 12 g (3 x 4 g) of the dietary fiber inulin in combination with 9.375 g (3 x 3.125 g (80% resistant starch (3 x 2.5 g)) granular potato starch

Two day supplementation of 11.43 g (3 x 3.81 g) maltodextrin

Outcomes

Primary Outcome Measures

24 hour intestinal gas concentrations
changes in intestinal gas excretion (methane, hydrogen or hydrogen sulphide will be measured using gas sensors in a modified respiration chamber)

Secondary Outcome Measures

24 hour energy expenditure
changes in 24 hour energy expenditure will be measured in a respiration chamber
24 hour substrate metabolism
changes in 24 hour substrate metabolism will be measured in a respiration chamber (fat and carbohydrate oxidation)
fecal microbial metabolite concentrations
the concentrations of fecal SCFA and BCFAs will be measured
Fecal microbiota composition
Faecal microbiota composition will be assessed via16S rRNA gene sequencing
24 hour glucose monitoring
24 hour glucoses concentrations will be measured using a wearable monitor during each testday
circulating blood markers
plasma blood glucose, insulin, GLP-1, glucagon, PYY, triglycerides, FFA, SCFA and BCFA
Urine metabolites
urinary concentrations of phenolic compounds, p-cresol and nitrogen will be measured

Full Information

First Posted
February 17, 2023
Last Updated
March 1, 2023
Sponsor
Maastricht University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05764200
Brief Title
Acute Microbial Switch
Official Title
Acute Microbial Switch Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2023 (Anticipated)
Primary Completion Date
October 31, 2025 (Anticipated)
Study Completion Date
October 31, 2025 (Anticipated)

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
In this project the investigators will test if it is possible to measure changes in intestinal gas production after supplementation of a complex fiber mixture over a 36 hour period in both lean normoglycemic individuals and individuals with insulin resistance and/or prediabetes with overweight when compared with a placebo Changes in intestinal gas production will also be related to energy expenditure, substrate metabolism, microbial composition and related metabolites in feces, blood and urine.
Detailed Description
In this project the investigators aim to test whether it is possible to precisely measure the changes in fermentation gas patterns after supplementation of a complex fibre mixture over a 36-hour period in both lean normoglycemic and individuals with insulin resistance and/or prediabetes with overweight when compared with a placebo. Additionally, the investigators will investigate whether changes in fermentation patterns will be directly related to changes in carbohydrate and fat oxidation and to microbial composition or related metabolites and hormones in blood, faeces, and urine.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Sensitivity, Glucose Metabolism Disorders (Including Diabetes Mellitus), Hyperinsulinism
Keywords
microbiota, insulin sensitivity, fiber

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Masking Description
double-blinded
Allocation
Randomized
Enrollment
28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
lean normoglycaemic individuals fiber mixture
Arm Type
Active Comparator
Arm Description
Two day supplementation of 12 g (3 x 4 g) of the dietary fiber inulin in combination with 9.375 g (3 x 3.125 g (80% resistant starch (3 x 2.5 g)) granular potato starch
Arm Title
lean normoglycaemic placebo
Arm Type
Placebo Comparator
Arm Description
Two day supplementation of 11.43 g (3 x 3.81 g) maltodextrin
Arm Title
overweight and/or obesity and prediabetes/insulin fiber mixture
Arm Type
Active Comparator
Arm Description
Two day supplementation of 12 g (3 x 4 g) of the dietary fiber inulin in combination with 9.375 g (3 x 3.125 g (80% resistant starch (3 x 2.5 g)) granular potato starch
Arm Title
overweight and/or obesity and prediabetes/insulin resistance placebo
Arm Type
Placebo Comparator
Arm Description
Two day supplementation of 11.43 g (3 x 3.81 g) maltodextrin
Intervention Type
Dietary Supplement
Intervention Name(s)
Two day supplementation of a complex fiber mixture
Intervention Description
Participants will undergo a two day supplementation of a complex fiber supplement vs. placebo with a two-week washout period between the two interventions in a randomized order
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo supplementation
Intervention Description
Participants will undergo a two day supplementation of a complex fiber supplement vs. placebo with a two-week washout period between the two interventions in a randomized order
Primary Outcome Measure Information:
Title
24 hour intestinal gas concentrations
Description
changes in intestinal gas excretion (methane, hydrogen or hydrogen sulphide will be measured using gas sensors in a modified respiration chamber)
Time Frame
after ingestion of the supplement up until 24 hours after supplementation continuously
Secondary Outcome Measure Information:
Title
24 hour energy expenditure
Description
changes in 24 hour energy expenditure will be measured in a respiration chamber
Time Frame
after ingestion of the supplement up until 24 hours after supplementation continuously
Title
24 hour substrate metabolism
Description
changes in 24 hour substrate metabolism will be measured in a respiration chamber (fat and carbohydrate oxidation)
Time Frame
after ingestion of the supplement up until 24 hours after supplementation continuously
Title
fecal microbial metabolite concentrations
Description
the concentrations of fecal SCFA and BCFAs will be measured
Time Frame
after ingestion of the supplement and 24 hours after supplementation
Title
Fecal microbiota composition
Description
Faecal microbiota composition will be assessed via16S rRNA gene sequencing
Time Frame
at baseline and 24 hours after supplementation
Title
24 hour glucose monitoring
Description
24 hour glucoses concentrations will be measured using a wearable monitor during each testday
Time Frame
after ingestion of the supplement up until 24 hours after supplementation
Title
circulating blood markers
Description
plasma blood glucose, insulin, GLP-1, glucagon, PYY, triglycerides, FFA, SCFA and BCFA
Time Frame
after ingestion of the supplement at multiple timepoints up until 24 hours after supplementation
Title
Urine metabolites
Description
urinary concentrations of phenolic compounds, p-cresol and nitrogen will be measured
Time Frame
at baseline up until 24 hours after supplementation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Lean normoglycemic individuals: Lean (BMI ≥ 18.5 kg/m2 and ≤ 24.9 kg/m2 ); Normal fasting glucose (plasma glucose < 5.6 mmol/L) and a HOMA-IR< 2.2 Individuals with overweight/obesity and prediabetes/insulin resistance: Overweight/obesity (BMI ≥ 28 kg/m2 and ≤ 40 kg/m2 ); insulin resistance (HOMA-IR>2.2) and/or impaired fasting glucose (IFG: plasma glucose ≥ 5.6 mmol/l) For both subject groups: Aged 30 - 75 years; Normal blood pressure (systolic blood pressure 100-150mmHg, diastolic blood pressure 60-100 mmHg); Weight stable for at least 3 months (± 2 kg) Exclusion Criteria: T2DM (defined as fasting plasma glucose ≥ 7.0 mmol/L) Gastroenterological diseases Abdominal surgery affecting the GI tract; Cardiovascular diseases, cancer, liver or kidney malfunction, disease with a life expectancy shorter than five years; Abuse of products; Alcohol (> 15 standard units per week) Drugs Excessive nicotine use defined as >20 cigarettes per day; Plans to lose weight or following of a hypocaloric diet Regular supplementation of pre- or probiotic products, use of pre- or probiotics three months prior to the start of the study; Intensive exercise training more than three hours a week; Use of most medications that influence glucose or fat metabolism, like some lipid lowering-drugs (e.g., PPAR γ or PPARα (fibrates) agonists), glucose-lowering agents (including all sulfonylureas, biguanides, α-glucosidase inhibitors, thiazolidinediones, repaglinide, nateglinide and insulin), inflammation (e.g., anti-inflammatory* or immunosuppressive drugs) and anti-oxidants; Regular use of laxatives; Use of antibiotics in the last three months (antibiotics use can alter substantially the gut microbiota composition). Veganism Lactose intolerance For women: pregnancy or lactation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gillian Larik, Msc
Phone
0433881641
Email
g.larik@maastrichtuniversity.nl
Facility Information:
Facility Name
Department of Human Biology, Maastricht University Medical Centre
City
Maastricht
ZIP/Postal Code
6200MD
Country
Netherlands
Facility Name
Maastricht University Medical Centre
City
Maastricht
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
anonymized data may be shared with other researchers for meta-analyses etc., however personalized data names etc. will not be made available

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Acute Microbial Switch

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