Acute Microbial Switch

Insulin Sensitivity Clinical Trial

Official title:

Acute Microbial Switch Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05764200
• Other study ID #: NL82078.068.22
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Glucose Metabolism Disorders
• Glucose Metabolism Disorders (Including Diabetes Mellitus)
• Hyperinsulinism
• Hypersensitivity
• Insulin Resistance
• Insulin Sensitivity
• Metabolic Diseases

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