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

RecruitingNAAges 18 Years - 60 YearsAllBiomeHub Biotechnology Company
NCT06051318 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 than a thousand bacteria species in our gastrointestinal tract that have an important role in the proper functioning of our body, so our gut microbiome is a key piece for our nutrition and blood glucose control. Nowadays, one of the major public health concerns is the rise of people with diabetes (a disease characterized by an increase in blood glucose) and the increase in obesity, in which one of several risks is diabetes. There are multiple reasons for people develop those diseases, however, some care on diet management can prevent, delay, or improve the effects of these illnesses. Therefore, this study proposes studying the blood glucose variation between healthy volunteers and if there

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📋 Eligibility rules (as published)
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
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What it tests

  • Standardized breakfast A
  • Standardized breakfast B
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Where

1 site
BiomeHub
Florianópolis, Brazil
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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