Gut microbial substrate switch to improve metabolic health

Recruiting

• Conditions: insulin resistance; overweight; 10018424

• Registration Number: NL-OMON49051
• Lead Sponsor: niversiteit Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 42

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Insulin sensitivity as assessed by a hyperinsulinemic euglycemic clamp </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- energy expenditure and substrate oxidation (indirect calorimetry)<br /><br>- adipose tissue and skeletal muscle gene/protein expression<br /><br>- faecal and circulating SCFA<br /><br>- faecal microbiota composition<br /><br>- circulating incretins, metabolites and inflammatory parameters<br /><br>- body weight, BMI and body composition (DEXA scan)<br /><br>- Three-day food record and physical activity questionnaires<br /><br>A three-day food record will be completed three days prior to each CID.<br /><br>- Gastrointestinal Symptom Rating Scale (GSRS) questionnaire.<br /><br>- Proton magnetic resonance spectrometry to assess liver fat content </p><br>