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Acute microbial switch study

Acute microbial switch study - Acute microbial switch

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON56140
Enrollment
56
Registered
2023-06-13
Start date
2024-01-03
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

insulin resistance overweight

Interventions

Starting from CID1, participants will start a two-day daily consumption of either a complex dietary fibre mixture: 12 g (3 × 4 g) of long-chain inulin (Frutafit TEX! Sensus B.V., Roosendaal, The Net

Sponsors

Universiteit Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Fourteen lean (BMI >= 18.5kg/m2 and = 28kg/m2 and 2.2) and/or impaired fasting glucose (IFG: plasma glucose >= 5.6 mmol/l) aged between 30 - 75 years will be included.

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 -pregant or breastfeeding

Design outcomes

Primary

MeasureTime frame
The difference in the 36h pattern of expired gut fermentation gases (H2S, H2 and CH4) after supplementation of a complex fibre mixture compared with placebo treatment in lean normoglycemic and overweight/obese prediabetic individuals. Furthermore we will compare the responses of the two different study populations.

Secondary

MeasureTime frame
- Energy expenditure and substrate oxidation over a 36h period (indirect calorimetry) - Faecal and circulating microbially derived metabolites - Circulating hormones insulin, PYY (peptide YY) and GLP-1 (glucagon like peptide-1) - Circulating metabolites (glucose, FFA, and triacylglycerols). - Faecal microbiota composition - Fecal and blood SCFAs acids and BCFAs - Urinary markers of proteolytic and saccharolytic fermentation - Three-day food record. A three-day food record will be completed three days prior to each CID. - Appetite (Visual Analog Scales (VAS)-scoring system for hunger and satiety). - Gastrointestinal Symptom Rating Scale (GSRS) questionnaire. The GSRS will be completed the day before and during the clinical investigation days. - Expired 13CO2 - Cortisol from saliva when waking up - Cognitive testing (CANTAB) The variables will be compared between ingestion of the fiber supplement versus the placebo. Additionally we will compare the responses between the two research populations included in the study.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)