Acute microbial switch study

Recruiting

• Conditions: insulin resistance; overweight; 10018424

• Registration Number: NL-OMON56140
• Lead Sponsor: niversiteit Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 56

Inclusion Criteria

Fourteen lean (BMI >= 18.5kg/m2 and <= 24.9kg/m2 ) normoglycemic individuals
(fasting glucose < 5.6 mol/L and HOMA-IR < 2.2) aged 30 - 75 years and fourteen
individuals with overweight/obesity (BMI >= 28kg/m2 and <= 40 kg/m2 ) with
insulin resistance (HOMA-IR>2.2) and/or impaired fasting glucose (IFG: plasma
glucose >= 5.6 mmol/l) aged between 30 - 75 years will be included.

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
-pregant or breastfeeding

Study & Design

• Study Type: Interventional
• Study Design: Not specified