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

NCT06051318 | Recruiting

• 1 other identifier: 68325123.0.0000.5355
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Glycemic response; Precision nutrition; Gut Microbiome; Biomarkers; Sequencing analysis; N-of-1 trials

Outcome Measures

Primary Outcomes (2)

• 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.

  0 min

• 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.

  0 min

Secondary Outcomes (1)

• Participant's gut microbiome species richness

  2 weeks

Study Arms (2)

Standardized breakfast A

EXPERIMENTAL

Consumption order: 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 A

Standardized breakfast B

EXPERIMENTAL

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

Other: Standardized breakfast B

Interventions

Standardized breakfast A OTHER

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

Standardized breakfast A

Standardized breakfast B OTHER

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

Standardized breakfast B

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• BiomeHub Biotechnology Company: lead

Study Sites (1)

BiomeHub

Florianópolis, Santa Catarina, 88054700, Brazil

RECRUITING

MeSH Terms

Conditions

Glucose Metabolism Disorders; Health Behavior; Diabetes Mellitus; Metabolic Diseases

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases; Behavior; Endocrine System Diseases

Study Officials

• Caetana P. Zamparette, PhD

  Researcher fellow

  STUDY CHAIR

• Bianca L. Teixeira, PhD

  Clinical research

  STUDY CHAIR

• Giuliano Netto, Msc

  Bioinformatics development and maintenance

  STUDY CHAIR

• Aline FR Sereia, PhD

  Chief Operating Officer

  STUDY CHAIR

• Ana P. Christoff, PhD

  Researcher R&D

  STUDY CHAIR

• Daniela C Bastiani, B.Sc

  Laboratory manager

  STUDY CHAIR

• Fernanda RG Piazza, Msc

  Nutricionist

  STUDY CHAIR

• Michele P Rode, PhD

  Product Owner

  STUDY CHAIR

• Milene H Moraes, PhD

  Researcher R&D

  STUDY CHAIR

• Natália M Gutierrez

  Laboratory analyst

  STUDY CHAIR

• Luiz Felipe V. de Oliveira, PhD

  BiomeHub CEO

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luiz Felipe V. de Oliveira, PhD

CONTACT

+554830121322; felipe@biome-hub.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study is a N-of-1 randomized series trial with multiple crossovers.

Study Record Dates

• First Submitted: September 12, 2023
• First Posted: September 22, 2023
• Study Start: June 6, 2024
• Primary Completion: December 30, 2024
• Study Completion: June 30, 2025
• Last Updated: October 24, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)