NL-OMON51442CompletedNot Applicable
sing a complex carbohydrate mixture added to a high-protein DIet to STeer fermentation to improve metabolic, gut and brain heALth - DISTAL-study
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- niversiteit Maastricht
- Enrollment
- 44
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •Male/female
- •Age 30-75 year
- •BMI 28-40 kg/m2 (weight in kg / length in m)
- •One of the following criteria: Fasting glucose 5.6 - 6.9 mmol/l OR HbA1c 42-47
- •mmol/mol OR HOMA-IR >1.85
Exclusion Criteria
- •Diabetes mellitus (type 1 or 2)
- •Cardiovascular disease: Including no history of myocardial infarction, heart
- •failure, arrhythmias (except hypertension (<160/100 or <140/90 mmHg without or
- •with medicinal treatment, respectively)
- •Pulmonary disease: no history of chronic obstructive pulmonary disease,
- •emphysema, bronchitis, asthma
- •Kidney disease/failure
- •Hepatic disease/failure
- •Gastrointestinal disease or a history of abdominal surgery (except appendectomy
- •and cholecystectomy): No inflammatory bowel disease, irritable bowel syndrome
- •and related diseases.
- •Any other diseases affecting glucose and/or lipid metabolism
- •Malignancy (except non-invasive skin cancer)
- •Auto-immune disease
- •Major mental disorders preventing correct participation (such as severe
- •depression, psychosis, schizophrenia)
- •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,
- •o Use of statins (stable use >=3 months prior to and during study is allowed)
- •o Use of antidepressants (stable use >=3 months prior to and during study is
- •o Use of anticoagulants (acetylsalicylic acid and carbasalate calcium are
- •o Use of medication known to interfere with study outcomes
- •o Use of β-blockers
- •o 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)
- •Following a vegan or vegetarian diet; presence of food allergies, intolerances
- •or diet restrictions interfering with the study.
Investigators
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