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

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.

Conditions

• Glucose Metabolism Disorders
• Health Behavior
• Diabetes
• Metabolic Disease

Interventions

OTHER

Standardized breakfast A

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

OTHER

Standardized breakfast B

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

Sponsors & Collaborators

• BiomeHub Biotechnology Company

  lead INDUSTRY

Principal Investigators

• Caetana P. Zamparette, PhD · Researcher fellow

• Bianca L. Teixeira, PhD · Clinical research

• Giuliano Netto, Msc · Bioinformatics development and maintenance

• Aline FR Sereia, PhD · Chief Operating Officer

• Ana P. Christoff, PhD · Researcher R&D

• Daniela C Bastiani, B.Sc · Laboratory manager

• Fernanda RG Piazza, Msc · Nutricionist

• Michele P Rode, PhD · Product Owner

• Milene H Moraes, PhD · Researcher R&D

• Natália M Gutierrez · Laboratory analyst

• Luiz Felipe V. de Oliveira, PhD · BiomeHub CEO

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-06-06

Primary Completion

2024-12-30

Completion

2025-06-30

Countries

• Brazil

Study Locations