Actively Recruiting

Phase Not Applicable
Age: 30Years - 75Years
All Genders
Healthy Volunteers
NCT05764200

Acute Microbial Switch

Led by Maastricht University Medical Center · Updated on 2024-08-22

28

Participants Needed

2

Research Sites

95 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Acute Microbial Switch

Who Can Participate

Age: 30Years - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Lean normoglycemic individuals with BMI between 18.5 and 24.9 kg/m2
  • Normal fasting glucose less than 5.6 mmol/L and HOMA-IR below 2.2 for lean group
  • Overweight or obesity with BMI between 28 and 40 kg/m2
  • Insulin resistance (HOMA-IR above 2.2) and/or impaired fasting glucose (plasma glucose 5.6 mmol/L or higher) for overweight group
  • Age between 30 and 75 years
  • Normal blood pressure: systolic 100-150 mmHg and diastolic 60-100 mmHg
  • Weight stable for at least 3 months with variation within ±2 kg
Not Eligible

You will not qualify if you...

  • Type 2 diabetes defined as fasting plasma glucose 7.0 mmol/L or higher
  • Gastroenterological diseases
  • Abdominal surgery affecting the gastrointestinal tract
  • Cardiovascular disease, cancer, liver or kidney malfunction, or diseases with life expectancy under five years
  • Abuse of alcohol (more than 15 standard units per week), drugs, or excessive nicotine use (more than 20 cigarettes per day)
  • Plans to lose weight or following a low-calorie diet
  • Regular use of pre- or probiotic supplements within three months before study
  • Intensive exercise training over three hours per week
  • Use of medications affecting glucose or fat metabolism, including certain lipid-lowering drugs, glucose-lowering agents, anti-inflammatory or immunosuppressive drugs, and antioxidants
  • Regular use of laxatives
  • Antibiotic use within the last three months
  • Vegan diet
  • Lactose intolerance
  • Pregnancy or breastfeeding for women

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

Department of Human Biology, Maastricht University Medical Centre

Maastricht, Netherlands, 6200MD

Actively Recruiting

2

Maastricht University Medical Centre

Maastricht, Netherlands

Actively Recruiting

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Research Team

G

Gillian Larik, Msc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

BASIC_SCIENCE

Number of Arms

4

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