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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorBiomeHub Biotechnology Company

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • Standardized breakfast A

    Other intervention

    Participants will initiate the interventional period by eating the low-carb muffin first following the established muffin order for the next days.

  • Standardized breakfast B

    Other intervention

    Participants will initiate the interventional period by eating the vegan muffin first following the established muffin order for the next days.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Standardized breakfast AExperimental treatment 1 intervention
Group B: Standardized breakfast BExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

All participants will measure fasting subcutaneous interstitial fluid glucose before breakfast with CGM device during 10 days of intervention. The device measures subcutaneous interstitial glucose in the mg/dL unit and the reading is done through the device's app by cell phone approximation. Data is retained in the app and will be shared with researchers.

Time frame
0 min
2

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

All participants will measure postprandial subcutaneous interstitial fluid glucose every 30 minutes over two hours after breakfast with CGM device during 10 days of intervention. The device measures subcutaneous interstitial glucose in the mg/dL unit and the reading is done through the device's app by cell phone approximation. Data is retained in the app and will be shared with researchers.

Time frame
0 min

Secondary outcomes

1

Participant's gut microbiome species richness

Gut microbiome profile will be performed by 16S sequencing from participant's fecal sample.

Time frame
2 weeks

Other outcomes

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