Relationship Between Individual Effect of Diet on Postprandial Glycemia and Gut Microbiome Profile in Healthy Subjects

Launched by BIOMEHUB BIOTECHNOLOGY COMPANY · Sep 20, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how different diets affect blood sugar levels in healthy individuals and whether the types of bacteria in our gut play a role in this process. When we eat, our blood sugar can rise, but not everyone experiences the same increase. Researchers want to find out if the gut microbiome, which is made up of many different bacteria, influences how our bodies respond to food. The goal is to help doctors and nutritionists create personalized diet plans for people who need to manage their blood sugar levels, especially considering the rising rates of diabetes and obesity.

If you're between 18 and 60 years old and live in the Florianopolis area, you might be eligible to participate. To take part, you need to be healthy, have a Body Mass Index (BMI) between 18.5 and 30, and be willing to monitor your blood sugar levels for ten days using a special device. Participants will collect stool samples and keep a food diary while enjoying standardized breakfast meals provided by the researchers. This study may help improve our understanding of diet and gut health, which could lead to better health outcomes for many people.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • BMI \> 18.5 and \< 30
• • Willing to use an intradermal continuous glucose monitoring sensor during the 10-day study
• • Own a mobile phone with NFC technology
• • Willing to provide a fecal swab sample and a stool sample
• • Understanding, agreement, and signing of the approved Informed Consent Form (ICF) by the Ethics Committee (CEP)
• Exclusion Criteria:
• • Pregnant or lactating women
• • Diagnosis of any gastrointestinal disorder or disease (Irritable Bowel Syndrome, Ulcerative Colitis, Crohn's Disease)
• • Intolerance or allergy to any diet ingredient
• • Autoimmune disorder (Lupus, Type 1 Diabetes, Celiac Disease) or infectious disease
• • Diabetes diagnosis
• • Cancer diagnosis, acute myocardial infarction, or stroke in the last 6 months
• • Use of hypoglycemic medication
• • Use of proton pump inhibitors, immunosuppressants, or antimicrobials in the last 3 months
• • Use of laxative medications in the last 30 days
• • Underwent invasive procedures or surgery in the last 6 months
• • Admission to ICU in the last 2 years
• • Participation in any experimental study or ingestion of any experimental drug within twelve months prior to the start of this study, in accordance with RDC 251/97
• • Inability to read and understand the informed consent form