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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05764200
Other study ID # NL82078.068.22
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 1, 2023
Est. completion date October 31, 2025

Study information

Verified date March 2023
Source Maastricht University Medical Center
Contact Gillian Larik, Msc
Phone 0433881641
Email g.larik@maastrichtuniversity.nl
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In this project the investigators will test if it is possible to measure changes in intestinal gas production after supplementation of a complex fiber mixture over a 36 hour period in both lean normoglycemic individuals and individuals with insulin resistance and/or prediabetes with overweight when compared with a placebo Changes in intestinal gas production will also be related to energy expenditure, substrate metabolism, microbial composition and related metabolites in feces, blood and urine.


Description:

In this project the investigators aim to test whether it is possible to precisely measure the changes in fermentation gas patterns after supplementation of a complex fibre mixture over a 36-hour period in both lean normoglycemic and individuals with insulin resistance and/or prediabetes with overweight when compared with a placebo. Additionally, the investigators will investigate whether changes in fermentation patterns will be directly related to changes in carbohydrate and fat oxidation and to microbial composition or related metabolites and hormones in blood, faeces, and urine.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 28
Est. completion date October 31, 2025
Est. primary completion date October 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 30 Years to 75 Years
Eligibility Inclusion Criteria: - Lean normoglycemic individuals: - Lean (BMI = 18.5 kg/m2 and = 24.9 kg/m2 ); - Normal fasting glucose (plasma glucose < 5.6 mmol/L) and a HOMA-IR< 2.2 Individuals with overweight/obesity and prediabetes/insulin resistance: - Overweight/obesity (BMI = 28 kg/m2 and = 40 kg/m2 ); - insulin resistance (HOMA-IR>2.2) and/or impaired fasting glucose (IFG: plasma glucose = 5.6 mmol/l) For both subject groups: - Aged 30 - 75 years; - Normal blood pressure (systolic blood pressure 100-150mmHg, diastolic blood pressure 60-100 mmHg); - Weight stable for at least 3 months (± 2 kg) Exclusion Criteria: - T2DM (defined as fasting plasma glucose = 7.0 mmol/L) - Gastroenterological diseases - Abdominal surgery affecting the GI tract; - Cardiovascular diseases, cancer, liver or kidney malfunction, disease with a life expectancy shorter than five years; - Abuse of products; - Alcohol (> 15 standard units per week) - Drugs - Excessive nicotine use defined as >20 cigarettes per day; - Plans to lose weight or following of a hypocaloric diet - Regular supplementation of pre- or probiotic products, use of pre- or probiotics three months prior to the start of the study; - Intensive exercise training more than three hours a week; - Use of most medications that influence glucose or fat metabolism, like some lipid lowering-drugs (e.g., PPAR ? or PPARa (fibrates) agonists), glucose-lowering agents (including all sulfonylureas, biguanides, a-glucosidase inhibitors, thiazolidinediones, repaglinide, nateglinide and insulin), inflammation (e.g., anti-inflammatory* or immunosuppressive drugs) and anti-oxidants; - Regular use of laxatives; - Use of antibiotics in the last three months (antibiotics use can alter substantially the gut microbiota composition). - Veganism - Lactose intolerance - For women: pregnancy or lactation

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Two day supplementation of a complex fiber mixture
Participants will undergo a two day supplementation of a complex fiber supplement vs. placebo with a two-week washout period between the two interventions in a randomized order
Placebo supplementation
Participants will undergo a two day supplementation of a complex fiber supplement vs. placebo with a two-week washout period between the two interventions in a randomized order

Locations

Country Name City State
Netherlands Department of Human Biology, Maastricht University Medical Centre Maastricht
Netherlands Maastricht University Medical Centre Maastricht

Sponsors (1)

Lead Sponsor Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary 24 hour intestinal gas concentrations changes in intestinal gas excretion (methane, hydrogen or hydrogen sulphide will be measured using gas sensors in a modified respiration chamber) after ingestion of the supplement up until 24 hours after supplementation continuously
Secondary 24 hour energy expenditure changes in 24 hour energy expenditure will be measured in a respiration chamber after ingestion of the supplement up until 24 hours after supplementation continuously
Secondary 24 hour substrate metabolism changes in 24 hour substrate metabolism will be measured in a respiration chamber (fat and carbohydrate oxidation) after ingestion of the supplement up until 24 hours after supplementation continuously
Secondary fecal microbial metabolite concentrations the concentrations of fecal SCFA and BCFAs will be measured after ingestion of the supplement and 24 hours after supplementation
Secondary Fecal microbiota composition Faecal microbiota composition will be assessed via16S rRNA gene sequencing at baseline and 24 hours after supplementation
Secondary 24 hour glucose monitoring 24 hour glucoses concentrations will be measured using a wearable monitor during each testday after ingestion of the supplement up until 24 hours after supplementation
Secondary circulating blood markers plasma blood glucose, insulin, GLP-1, glucagon, PYY, triglycerides, FFA, SCFA and BCFA after ingestion of the supplement at multiple timepoints up until 24 hours after supplementation
Secondary Urine metabolites urinary concentrations of phenolic compounds, p-cresol and nitrogen will be measured at baseline up until 24 hours after supplementation
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