insulin resistance overweight
Conditions
Interventions
In this study there will be two different intervention groups:
1. WholeFiberTM product (First two weeks: 2x 7.5g per day, last ten weeks: 2x
15g per day)
2. Placebo: Puffed Millet (First two weeks 2
Sponsors
Universiteit Maastricht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Overweight/obese (BMI >= 28 kg/m2 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insulin sensitivity as assessed by a hyperinsulinemic euglycemic clamp | — |
Secondary
| Measure | Time frame |
|---|---|
| - energy expenditure and substrate oxidation (indirect calorimetry) - adipose tissue and skeletal muscle gene/protein expression - faecal and circulating SCFA - faecal microbiota composition - circulating incretins, metabolites and inflammatory parameters - body weight, BMI and body composition (DEXA scan) - Three-day food record and physical activity questionnaires A three-day food record will be completed three days prior to each CID. - Gastrointestinal Symptom Rating Scale (GSRS) questionnaire. - Proton magnetic resonance spectrometry to assess liver fat content | — |
Countries
Netherlands
Outcome results
None listed