Using a Complex Carbohydrate Mixture to Steer Fermentation and Improve Metabolism in Adults With … (NCT05354245) | Clinical Trial Compass
CompletedNot Applicable
Using a Complex Carbohydrate Mixture to Steer Fermentation and Improve Metabolism in Adults With Overweight and Prediabetes (DISTAL)
Netherlands44 participantsStarted 2022-09-08
Plain-language 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.
Who can participate
Age range30 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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 st…