Status:
COMPLETED
Personalized Fiber and Insulin Sensitivity
Lead Sponsor:
Maastricht University Medical Center
Conditions:
Type 2 Diabetes
Insulin Resistance
Eligibility:
All Genders
30-70 years
Phase:
NA
Brief Summary
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 objecti...
Eligibility Criteria
Inclusion
- Overweight/obese insulin resistant/prediabetic participants (age 30-70 y, BMI ≥ 28 kg/m2 \< 40 kg/m2)
Exclusion
- Type 2 diabetes mellitus (defined as fasting plasma glucose ≥ 7.0 mmol/L and 2h glucose ≥ 11.1 mmol/L)
- Gastroenterological diseases or abdominal surgery;
- Cardiovascular diseases, cancer, liver or kidney malfunction, disease with a life expectancy shorter than 5 years;
- Abuse of products; alcohol and 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 3 months prior to the start of the study;
- Intensive exercise training more than three hours a week;
- Use of any medication that influences glucose or fat metabolism and inflammation (i.e. NSAIDs);
- 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.
Key Trial Info
Start Date :
November 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 22 2024
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT05378295
Start Date
November 5 2021
End Date
April 22 2024
Last Update
April 23 2024
Active Locations (1)
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1
Maastricht University
Maastricht, Limburg, Netherlands, 5229ER