Providing Personally Tailored Dietary Suggestions Using Individual Microbiome and Glycemic Index Response.

Healthy Volunteers Clinical Trial

Official title:

Validation of the Measurement and Prediction of the Postprandial Glycemic Response to Food and Providing Personally Tailored Dietary Recommendations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02945514
• Other study ID #: 16-005208
• Status: Completed
• Phase: N/A
• First received: October 24, 2016
• Last updated: February 27, 2018
• Start date: September 2016
• Est. completion date: February 28, 2018

Study information

• Verified date: February 2018
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Provide personally tailored dietary suggestions to participants based on the Personalized Prediction Engine (patent pending) owned by DayTwo.

Description:

• Answer personal questions including such things as health information, eating habits and preferences, activity level and intensity.

• Submit a first stool sample via a self-addressed, postage-paid kit that is mailed to you.

• Attend one of the 2 hour connection meetings based on available dates.

• The study team will collect vitals: measurements of height, weight, blood pressure, pulse, waist and hip circumference.

• You will have a Blood collection for study (approximately 35 ml of blood/5 tubes)

• You will be provided a FitBit wrist band that you will wear

• You will be provided a manual blood glucose monitor you will use for pricking finger and measuring blood sugar level at least 4 times per day.

• You will have a continuous blood glucose sensor and monitor inserted by study staff.

• You will use DayTwo's mobile application where you will input food eaten, activity, measurements, medications, and sleep.

• You will be given a second stool kit and instructions for collection.

• You will be asked to eat 4 breakfasts consisting of either bagels and cream cheese or cereal. These foods will be provided for you. Other than these four breakfasts, we would like you to follow your normal eating habits during the collection week.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 327
• Est. completion date: February 28, 2018
• Est. primary completion date: February 27, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age or older

• Comprehension of the study objectives and requirements

• Ability to download the DayTwo proprietary mobile application

• Ability to access the DayTwo website for registration and nutrition report

Exclusion Criteria:

• Under 18 years of age

• Pre-diagnosed type I or type II diabetes mellitus

• Pregnancy

• Use of antibiotics or fertility treatments within 3 months prior to participation

• Bariatric weight loss surgery

• Chronic Anemia (hemoglobin of 10g per deciliter or less

• Chronic gastrointestinal disorder (IBD, Celiac, etc.)

• Active cancer or chemotherapy or radiation within 2 years prior to participation

• Condition not allowing to follow the dietary recommendation during the study

• 4 or more alcoholic drinks per day on a regular basis or use of recreational drugs

• Chronic medical condition, treatment, or medication that may affect glucose metabolism (HIV diagnosis, use of steroids or immunosuppressive drugs, etc.)

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Other:
• DayTwo machine learning algorithm
Personally tailored nutrition insights based on DayTwo machine learning algorithm when combining facets of your postprandial glycemic response to food consumed during collection week and your individual gut microbiome composition

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	DayTwo

Country where clinical trial is conducted

United States, 

References & Publications (1)

Zeevi D, Korem T, Zmora N, Israeli D, Rothschild D, Weinberger A, Ben-Yacov O, Lador D, Avnit-Sagi T, Lotan-Pompan M, Suez J, Mahdi JA, Matot E, Malka G, Kosower N, Rein M, Zilberman-Schapira G, Dohnalová L, Pevsner-Fischer M, Bikovsky R, Halpern Z, Elinav E, Segal E. Personalized Nutrition by Prediction of Glycemic Responses. Cell. 2015 Nov 19;163(5):1079-1094. doi: 10.1016/j.cell.2015.11.001. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postprandial blood sugar level		Baseline through 7 days

External Links

•   Click here for more information about this study: Validation Study of measurement and prediction of the postprandial glycemic response to food and providing personally tailored dietary information