NCT05378295Completed
Personalized Fiber and Insulin Sensitivity
Personalized Microbial Substrates to Prevent Type 2 Diabetes
Source: ClinicalTrials.gov · Last updated 23 Apr 2024
Brief summary (registry, in English)
In this project the investigators intend to study the therapeutic potential of a personalized fibre mixture in individuals at high risk of developing T2DM, and aim to address the following key objectives: 1. To investigate whether a mixture of fermentable fibres, which differ in DP and side chains, will stimulate a broad range of SCFA-producing bacterial genera, resulting in enhanced chronic SCFA production throughout the whole colon with a large variation between individuals; 2. To unravel whether providing personalized fibre mixtures, selected based on the individuals' initial microbiota and capacity for SCFA production is crucial to successfully improve host insulin sensitivity and metabolic health
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 44 (actual)
- First submitted
- 12 May 2022
- Start date
- 5 Nov 2021
- Primary completion date
- 22 Apr 2024
- Lead sponsor
- Maastricht University Medical Center
- Diseases
- Type 2 diabetes
- NCT number
- NCT05378295
What you commit to
- Study type: Interventional
- Participants enrolled: 44
- From 5 Nov 2021 to the primary completion date, 22 Apr 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Abuse of products; alcohol and drugs, excessive nicotine use defined as \>20 cigarettes per day;
- Regular supplementation of pre- or probiotic products, use of pre- or probiotics 3 months prior to the start of the study;
Other illness
- Gastroenterological diseases or abdominal surgery;
- Cardiovascular diseases, cancer, liver or kidney malfunction, disease with a life expectancy shorter than 5 years;
Lab values
- Type 2 diabetes mellitus (defined as fasting plasma glucose ≥ 7.0 mmol/L and 2h glucose ≥ 11.1 mmol/L)
- Use of any medication that influences glucose or fat metabolism and inflammation (i.e. NSAIDs);
Other
- Plans to lose weight or following of a hypocaloric diet;
- Intensive exercise training more than three hours a week;
- Regular use of laxation products;
- Use of antibiotics in the last three months (antibiotics use can alter substantially the gut microbiota composition).
- Follow a vegetarian diet.
Who the study is looking for
- Overweight/obese insulin resistant/prediabetic participants (age 30-70 y, BMI ≥ 28 kg/m2 \< 40 kg/m2)
Age in the registry: 30 years to 70 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Maastricht University Coordinator of this site? Confirm its status | Maastricht | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.