Acute Microbial Switch

NCT05764200 | Recruiting DMC

• 1 other identifier: NL82078.068.22
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

microbiota; insulin sensitivity; fiber

Outcome Measures

Primary Outcomes (1)

• 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)

  after ingestion of the supplement up until 24 hours after supplementation continuously

Secondary Outcomes (7)

• 24 hour energy expenditure

  after ingestion of the supplement up until 24 hours after supplementation continuously

• 24 hour substrate metabolism

  after ingestion of the supplement up until 24 hours after supplementation continuously

• fecal microbial metabolite concentrations

  after ingestion of the supplement and 24 hours after supplementation

• Fecal microbiota composition

  at baseline and 24 hours after supplementation

• 24 hour glucose monitoring

  after ingestion of the supplement up until 24 hours after supplementation

Study Arms (4)

lean normoglycaemic individuals fiber mixture

ACTIVE COMPARATOR

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

Dietary Supplement: Two day supplementation of a complex fiber mixture

lean normoglycaemic placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo supplementation

overweight and/or obesity and prediabetes/insulin fiber mixture

ACTIVE COMPARATOR

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

Dietary Supplement: Two day supplementation of a complex fiber mixture

overweight and/or obesity and prediabetes/insulin resistance placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo supplementation

Interventions

Two day supplementation of a complex fiber mixture DIETARY_SUPPLEMENT

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

lean normoglycaemic individuals fiber mixture; overweight and/or obesity and prediabetes/insulin fiber mixture

Placebo supplementation DIETARY_SUPPLEMENT

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

lean normoglycaemic placebo; overweight and/or obesity and prediabetes/insulin resistance placebo

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (2)

Department of Human Biology, Maastricht University Medical Centre

Maastricht, 6200MD, Netherlands

RECRUITING

Maastricht University Medical Centre

Maastricht, Netherlands

RECRUITING

MeSH Terms

Conditions

Insulin Resistance; Glucose Metabolism Disorders; Hyperinsulinism

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Gillian Larik, Msc

CONTACT

0433881641; g.larik@maastrichtuniversity.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double-blinded
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2023
• First Posted: March 10, 2023
• Study Start: January 1, 2024
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: August 22, 2024

Record last verified: 2024-08

Locations

NL (2)