Actively Recruiting
Acute Microbial Switch Study Measuring Intestinal Gas and Metabolism After Fiber Supplementation in Adults With Normal and Impaired Glucose Metabolism
Led by Maastricht University Medical Center · Updated on 2024-08-22
28
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating whether changes in intestinal gas production can be precisely measured after taking a complex fiber mixture over 36 hours. The study includes both lean individuals with normal blood sugar and overweight individuals with insulin resistance or prediabetes. They will compare fiber supplementation to a placebo and explore how gas changes relate to energy use, metabolism, and gut microbes. Participants will receive either a two-day supplementation of a fiber mixture containing inulin and resistant starch or a placebo maltodextrin supplement. There is a two-week washout period between the two randomized interventions. The study uses a double-blind design and includes groups of lean normoglycemic individuals and overweight or prediabetic individuals. During the study, participants will have continuous measurements of intestinal gas, energy expenditure, substrate metabolism, and glucose levels for 24 hours after supplementation. Researchers will also analyze microbial metabolites and composition in feces, blood markers at multiple time points, and urine metabolites. The entire observation period covers 36 hours after supplementation to assess these outcomes comprehensively.
CONDITIONS
Brief Title
Acute Microbial Switch
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 30 to 75 years
- Lean individuals with BMI between 18.5 and 24.9 kg/m2 and normal fasting glucose (plasma glucose < 5.6 mmol/L) with HOMA-IR < 2.2
- Overweight or obese individuals with BMI between 28 and 40 kg/m2 and insulin resistance (HOMA-IR > 2.2) and/or impaired fasting glucose (plasma glucose ≥ 5.6 mmol/L)
- Normal blood pressure (systolic 100-150 mmHg, diastolic 60-100 mmHg)
- Weight stable for at least 3 months with no more than ±2 kg change
You will not qualify if you...
- Type 2 diabetes mellitus (fasting plasma glucose ≥ 7.0 mmol/L)
- Gastroenterological diseases
- Abdominal surgery affecting the gastrointestinal tract
- Cardiovascular diseases, cancer, liver or kidney malfunction, or diseases with life expectancy shorter than five years
- Abuse of alcohol (> 15 standard units per week), drugs, or excessive nicotine use (> 20 cigarettes per day)
- Plans to lose weight or following a hypocaloric diet
- Regular use of pre- or probiotic supplements within 3 months prior to study start
- Intensive exercise training more than three hours per week
- Use of medications that affect glucose or fat metabolism, including lipid-lowering drugs, glucose-lowering agents, anti-inflammatory or immunosuppressive drugs, and antioxidants
- Regular use of laxatives
- Use of antibiotics within the last three months
- Veganism
- Lactose intolerance
- Pregnancy or lactation in women
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Two days per supplementation with a two-week washout period between interventions
Participants undergo two separate two-day supplementations with either a complex fiber mixture or a placebo, with a two-week washout period between the two interventions.
2 supplementation periods each lasting 2 days, separated by a 2-week washout
Duration - 24 hours after each supplementation
Participants are monitored continuously for 24 hours after each supplementation to measure intestinal gas concentrations, energy expenditure, substrate metabolism, glucose levels, blood markers, and urine metabolites, as well as fecal microbiota composition at baseline and 24 hours after supplementation.
Continuous monitoring for 24 hours after each supplementation
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
Research Team
G
Gillian Larik, Msc
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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