sing a complex carbohydrate mixture added to a high-protein DIet to STeer fermentation to improve metabolic, gut and brain heALth

Completed

• Conditions: Obesitas; Insulin resistance; prediabetes; 10018424

• Registration Number: NL-OMON51442
• Lead Sponsor: niversiteit Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 July 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 44

Inclusion Criteria

Male/female
Age 30-75 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 HbA1c 42-47
mmol/mol OR HOMA-IR >1.85

Exclusion Criteria

Diabetes mellitus (type 1 or 2)
Cardiovascular disease: Including no history of myocardial infarction, heart
failure, arrhythmias (except hypertension (<160/100 or <140/90 mmHg without or
with medicinal treatment, respectively)
Pulmonary disease: no history of chronic obstructive pulmonary disease,
emphysema, bronchitis, asthma
Kidney disease/failure
Hepatic disease/failure
Gastrointestinal disease or a history of abdominal surgery (except appendectomy
and cholecystectomy): No inflammatory bowel disease, irritable bowel syndrome
and related diseases.
Any other diseases affecting glucose and/or lipid metabolism
Malignancy (except non-invasive skin cancer)
Auto-immune disease
Major mental disorders preventing correct participation (such as severe
depression, psychosis, schizophrenia)
Ongoing (infectious) disease or any disease with a life expectancy <=5 years
Substance abuse (nicotine abuse (including e-cigarettes) defined as >20
cigarettes per day; alcohol abuse defined as >=8 drinks/week for females and >=15
drinks/week for males(38); any drugs)
A change in weight >=3kg over the last 3 months or plans to lose weight or
follow a hypocaloric diet during the study period
Pre/pro/antibiotic use in the last 3 months or during the study
Use of medication that influences glucose or fat metabolism and inflammation,
such as:
o Use of statins (stable use >=3 months prior to and during study is allowed)
o Use of antidepressants (stable use >=3 months prior to and during study is
allowed)
o Use of anticoagulants (acetylsalicylic acid and carbasalate calcium are
allowed)
o Use of medication known to interfere with study outcomes
o Use of β-blockers
o Chronic corticosteroid treatment (>7 consecutive days)
Regular use of laxatives 3 months prior to the study or during study period
Change in physical activity or diet during study period
Intensive physical activity (>3h per week)
Pregnancy
Following a vegan or vegetarian diet; presence of food allergies, intolerances
or diet restrictions interfering with the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main endpoint is the difference in change in peripheral muscle insulin<br /><br>between intervention and control group, measured by hyperinsulinemic-euglycemic<br /><br>clamp.</p><br>