Actively Recruiting
Relationship Between Individual Effect of Diet on Postprandial Glycemia and Gut Microbiome Profile in Healthy Subjects
Led by BiomeHub Biotechnology Company · Updated on 2024-10-24
80
Participants Needed
1
Research Sites
55 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Relationship Between Individual Effect of Diet on Postprandial Glycemia and Gut Microbiome Profile in Healthy Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Body mass index (BMI) greater than 18.5 and less than 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
- Understand, agree to, and sign the approved Informed Consent Form
You will not qualify if you...
- Pregnant or lactating women
- Diagnosis of any gastrointestinal disorder or disease such as Irritable Bowel Syndrome, Ulcerative Colitis, or Crohn's Disease
- Intolerance or allergy to any ingredient in the diet
- Autoimmune disorders like Lupus, Type 1 Diabetes, or Celiac Disease, or infectious diseases
- Diagnosis of diabetes
- 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 intensive care unit in the last 2 years
- Participation in any experimental study or use of experimental drugs within 12 months before this study
- Inability to read and understand the informed consent form
AI-Screening
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Trial Site Locations
Total: 1 location
1
BiomeHub
Florianópolis, Santa Catarina, Brazil, 88054700
Actively Recruiting
Research Team
L
Luiz Felipe V. de Oliveira, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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