Exploring how diet affects blood sugar levels and gut bacteria in healthy individuals
Individual Effect of Diet on Postprandial Glycemic Response and Its Relationship with Gut Microbiome Profile in Healthy Subjects: Protocol for a Series of Randomized N-of-1 Trials
This study is testing how different types of muffins affect blood sugar levels and gut bacteria in healthy people to see if diet can help manage glucose better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | BiomeHub Biotechnology Company Industry-sponsored |
| Locations | 1 site (Florianópolis, Santa Catarina) |
| Trial ID | NCT06051318 on ClinicalTrials.gov |
What this trial studies
This study investigates the relationship between dietary intake and postprandial glycemia, focusing on how individual gut microbiome profiles influence blood glucose responses. Healthy volunteers will participate in a randomized crossover design, consuming two types of standardized muffins over ten days while monitoring their glucose levels. Participants will also provide fecal samples for microbiome analysis, allowing researchers to assess the connection between gut bacteria and glycemic variation. The study aims to enhance understanding of precision nutrition and its potential impact on glucose metabolism.
Who should consider this trial
Good fit: Ideal candidates are healthy adults with a BMI between 18.5 and 30 who are willing to participate in glucose monitoring and provide fecal samples.
Not a fit: Patients with diabetes, gastrointestinal disorders, or other specified health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to personalized dietary recommendations that improve blood glucose control and reduce the risk of diabetes.
How similar studies have performed: While the relationship between diet, gut microbiome, and glycemic response has been explored, this specific approach using an N-of-1 design is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Florianópolis, Santa Catarina
- BiomeHub — Florianópolis, Santa Catarina, Brazil (Recruiting)
Study contacts
- Principal investigator: Luiz Felipe V. de Oliveira, PhD — BiomeHub CEO
- Study coordinator: Luiz Felipe V. de Oliveira, PhD
- Email: felipe@biome-hub.com
- Phone: +554830121322
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.