NL-OMON49051RecruitingNot Applicable
Gut microbial substrate switch to improve metabolic health - WholeFiber Study
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- niversiteit Maastricht
- Enrollment
- 42
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •Overweight/obese (BMI >= 28 kg/m2 < 35 kg/m2) with insulin resistance
- •(HOMA-IR>2.2) and/or impaired glucose tolerance (IGT: 2h plasma glucose during
- •75g OGTT 7.8-11.1 mmol/l) and/or impaired fasting glucose (IFG: plasma glucose
- •>= 5.6 mmol/l) aged 45-70 years
Exclusion Criteria
- •- diabetes mellitus
- •- gastroenterological diseases or major abdominal surgery (allowed i.e.:
- •appendectomy, cholecystectomy)
- •- lactose intolerance and other digestive disorders
- •- cardiovascular disease, cancer, liver or kidney malfunction (determined based
- •on ALAT and creatinine levels,
- •respectively)
- •- disease with a life expectancy shorter than 5 years
- •- abuse of products (alcohol consumption > 15 units/week, or any drugs)
- •- excessive nicotine use defined as >20 cigarettes per day
- •- plans to lose weight or follow a hypocaloric diet
- •- regular supplement of pre- or probiotic products
- •- intensive exercise more than three hours a week
- •- - use of any medication that influences glucose or fat metabolism and
- •inflammation, like i.e. lipid
- •lowering-drugs (e.g. PPAR γ or PPARa (fibrates) agonists), glucose-lowering
- •agents (including all
- •sulfonylureas, biguanides, a-glucosidase inhibitors, thiazolidinediones,
- •repaglinide, nateglinide and insulin),
- •anti-oxidants or chronic corticosteroids treatment.
- •- use of laxation products in the last three months or during the study period
Investigators
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