RecruitingNot Applicable

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

Brazil80 participantsStarted 2024-06-06

Plain-language 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 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 is a relationship between that variation and the intestinal bacteria present. These results can help doctors and nutritionists elaborate a personalized diet for people who need blood glucose level control. The investigators are recruiting volunteers aged 18 to 60, healthy, living at Florianopolis and the surroundings to participate in this crossover randomized N-of-1 study. The participants must collect fecal samples. After collection, the participants will meet the investigators and receive a kit containing ten standardized breakfasts, with two kinds of muffins, and a kit containing a glucose monitor (Abbott Freestyle Libre-CE marked) to monitor their blood sugar levels. The volunteers must have breakfast with the standardized meals and monitor the fasting glucose blood and postprandial glucose blood levels for ten consecutive days. Besides, they must take notes (like a diet diary) about all the food they ingest during the day in ten days of the study.

Who can participate

Age range18 Years – 60 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Fasting subcutaneous interstitial fluid glucose measured by continuous glucose monitor (CGM)

Timeframe: 0 min

Postprandial subcutaneous interstitial fluid glucose measured by continuous glucose monitor (CGM)

Timeframe: 0 min

Trial details

NCT IDNCT06051318

SponsorBiomeHub Biotechnology Company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-12-30

Contact for this trial

Luiz Felipe V. de Oliveira, PhD

+554830121322 felipe@biome-hub.com