Trials / Recruiting
RecruitingNCT05764200
Acute Microbial Switch
Acute Microbial Switch Study
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 28 (estimated)
- Sponsor
- Maastricht University Medical Center · Academic / Other
- Sex
- All
- Age
- 30 Years – 75 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Two day supplementation of a complex fiber mixture | 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 |
| DIETARY_SUPPLEMENT | Placebo supplementation | 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 |
Timeline
- Start date
- 2024-01-01
- Primary completion
- 2025-10-31
- Completion
- 2025-10-31
- First posted
- 2023-03-10
- Last updated
- 2024-08-22
Locations
2 sites across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT05764200. Inclusion in this directory is not an endorsement.