Status:
RECRUITING
Relationship Between Individual Effect of Diet on Postprandial Glycemia and Gut Microbiome Profile in Healthy Subjects
Lead Sponsor:
BiomeHub Biotechnology Company
Conditions:
Glucose Metabolism Disorders
Health Behavior
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
When all the food we eat is digested, it will increase blood glucose. Two people can have different glucose blood levels to the same food and one reason can be bacteria live in our gut. There are more...
Detailed Description
Choice of design: The study is a N-of-1 randomized series trial with multiple crossovers. Study population: This study will monitor healthy volunteers and they will be recruited via social media like...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 6 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2025
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06051318
Start Date
June 6 2024
End Date
June 30 2025
Last Update
October 24 2024
Active Locations (1)
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1
BiomeHub
Florianópolis, Santa Catarina, Brazil, 88054700