Obesitas Insulin resistance prediabetes
Conditions
Interventions
This study has two different groups receiving either the investigational
product or placebo:
- Investigational product: butyrate/hexanoate-enriched triglyceride oil
(approximately 12.5 mL per day fo
Sponsors
Universiteit Maastricht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Male/female Age 20-70 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 postprandial glucose (2h) 7.8-11.1 mmol/l OR HOMA-IR>2.2
Exclusion criteria
Exclusion criteria: Cardiovascular, pulmonary, metabolic (including diabetes mellitus), gastro-intestinal, liver, kidney or auto-immune disease Malignancy or disease with life expectancy 3kg in past 3 months Pre/pro/antibiotic use past 3 months or during trial Use of medication interfering with study outcomes Streneous physical activity (>3h per week) Diet-restrictions (hypocaloric, vegan, vegetarian) Pregnancy Use of laxatives Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main endpoint is the difference in change in peripheral insulin sensitivity between intervention and control group, measured by hyperinsulinemic-euglycemic clamp. | — |
Secondary
| Measure | Time frame |
|---|---|
| Differences in changes in pre- and posttreatment values between intervention and control group, regarding the following parameters/endpoints; - Hepatic and adipose tissue insulin sensitivity - Energy and substrate metabolism (energy harvest, intake, expenditure, carbohydrates and fat oxidation) - Body weight, composition and body fat distribution (anthropometrics, DEXA) - Plasma and faecal concentrations of butyrate, propionate and acetate (SCFA) - Plasma concentrations of inflammatory markers (C-Reactive Protein (CRP), Interleukin-10 (IL-10), Tumornecrosefactor-a (TNF-a), Interferon- γ (INF-γ), circulating metabolites (glucose, triglycerides, FFAs) and hormones (insulin, GLP-1, PYY, glucagon) - Gut permeability - Faecal microbiota composition and functionality (Metagenome and -transcriptome sequencing) - Gastrointestinal side effects (GRGS) - Expression of gene and protein expression in adipose tissue Other study parameters (if applicable) - Plasma HbA1c over the different timepoints; screening, CID1, visit week 12 and CID2 - Three-day food record: completed before CID1 and CID2 and the visit week 12 - Physical activity questionnaire: completed before CID1 and CID2 and visit week 12 (SQUASH) - Questionnaires on general wellbeing/quality of life and stress | — |
Countries
Netherlands
Outcome results
None listed