Acute Microbial Switch

Launched by MAASTRICHT UNIVERSITY MEDICAL CENTER · Mar 1, 2023

Keywords

ClinConnect Summary

This clinical trial, called the Acute Microbial Switch, is exploring how a specific fiber supplement affects gas production in the intestines over a 36-hour period. The study involves two groups of participants: one group consists of lean individuals without blood sugar issues, and the other group includes people who are overweight or have prediabetes and insulin resistance. By comparing these two groups to a placebo group (who will not receive the fiber supplement), researchers hope to understand how changes in gas production relate to energy use and the makeup of gut bacteria.

To be eligible for this trial, participants should be between the ages of 30 and 75, have stable weight, and meet certain health criteria. Lean participants must have a normal body mass index (BMI) and healthy blood sugar levels, while those with insulin resistance should have a higher BMI and specific blood sugar measurements. Participants will need to avoid certain medications and dietary restrictions during the study. If you decide to take part, you can expect to contribute to important research that may help improve our understanding of glucose metabolism and gut health.

Gender

ALL

Eligibility criteria

• 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 γ or PPARα (fibrates) agonists), glucose-lowering agents (including all sulfonylureas, biguanides, α-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