Status:
COMPLETED
Using a Complex Carbohydrate Mixture to Steer Fermentation and Improve Metabolism in Adults With Overweight and Prediabetes (DISTAL)
Lead Sponsor:
Maastricht University Medical Center
Collaborating Sponsors:
Carbohydrate Competence Center
Conditions:
Insulin Resistance
Impaired Glucose Tolerance
Eligibility:
All Genders
30-75 years
Phase:
NA
Brief Summary
The purpose of this study is to investigate the effects of a fibre mixture added to a high-protein diet on metabolic, gut and brain health.
Detailed Description
The fibre mixture that will be investigated is hypothesized to improved metabolic, gut and brain health. It potentially increases insulin sensitivity, satiety, gut barrier function, improves food-rewa...
Eligibility Criteria
Inclusion
- Age 30-75 years
- Male/female
- BMI 28-40 kg/m2
- Impaired fasting glucose or glucose tolerance, determined using the following criteria (participant should meet at least one criteria):
- HbA1c 42-47 mmol/mol OR fasting glucose (\>10h fasted) 5.6-6.9 mmol/l OR Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) \>1.85
Exclusion
- Diabetes mellitus (type 1 or 2)
- Cardiovascular disease (except hypertension (\<160/100mmHg is allowed), pulmonary disease, kidney disease/failure, liver disease/failure
- Gastrointestinal disease or a history of abdominal surgery (except appendectomy and cholecystectomy)
- Diseases affecting glucose and/or lipid metabolism
- Malignancy (except non-invasive skin cancer)
- Auto-immune disease
- Major mental disorders
- Ongoing (infectious) disease or any disease with a life expectancy ≤5 years
- Substance abuse (nicotine abuse (including e-cigarettes) defined as \>20 cigarettes per day; alcohol abuse defined as ≥8 drinks/week for females and ≥15 drinks/week for males(38); any drugs)
- A change in weight ≥3kg over the last 3 months or plans to lose weight or follow a hypocaloric diet during the study period
- Pre/pro/antibiotic use in the last 3 months or during the study
- Use of medication that influences glucose or fat metabolism and inflammation, such as:
- Use of statins (stable use ≥3 months prior to and during study is allowed)
- Use of antidepressants (stable use ≥3 months prior to and during study is allowed)
- Use of specific anticoagulants
- Use of medication known to interfere with study outcomes
- Use of β-blockers
- Chronic corticosteroid treatment (\>7 consecutive days)
- Regular use of laxatives 3 months prior to the study or during study period
- Change in physical activity or diet during study period
- Intensive physical activity (\>3h per week)
- Pregnancy
- Following a vegan or vegetarian diet; presence of food allergies, intolerances or diet restrictions interfering with the study.
Key Trial Info
Start Date :
September 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 10 2024
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT05354245
Start Date
September 8 2022
End Date
June 10 2024
Last Update
June 27 2024
Active Locations (1)
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1
Maastricht University
Maastricht, Netherlands, 6229ER