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

• ClinicalTrials.gov Identifier: NCT02945514
• Recruitment Status: Completed
• First Posted: October 26, 2016
• Last Update Posted: February 28, 2018
• Sponsor: Mayo Clinic
• Collaborator: DayTwo
• Information provided by (Responsible Party): Heidi Nelson, Mayo Clinic

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment
Healthy Volunteers	Other: DayTwo machine learning algorithm

Detailed 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.

Study Design

• Study Type: Observational
• Actual Enrollment: 327 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Validation of the Measurement and Prediction of the Postprandial Glycemic Response to Food and Providing Personally Tailored Dietary Recommendations
• Study Start Date: September 2016
• Actual Primary Completion Date: February 27, 2018
• Actual Study Completion Date: February 28, 2018

Groups and Cohorts

Intervention Details:

• 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

Outcome Measures

Primary Outcome Measures :

1. Postprandial blood sugar level [ Time Frame: Baseline through 7 days ]

Biospecimen Retention:   Samples With DNA

Whole blood and Stool

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

Men and women above 18 years of age.

Criteria

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.)

Contacts and Locations

Locations

United States, Minnesota

Mayo Clinic

Rochester, Minnesota, United States, 55902-9823

Sponsors and Collaborators

Mayo Clinic

DayTwo

Investigators

• Principal Investigator: Heidi Nelson, M.D.; Mayo Clinic

More Information

Additional Information:

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 

Publications:

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, Dohnalova 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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Mendes-Soares H, Raveh-Sadka T, Azulay S, Ben-Shlomo Y, Cohen Y, Ofek T, Stevens J, Bachrach D, Kashyap P, Segal L, Nelson H. Model of personalized postprandial glycemic response to food developed for an Israeli cohort predicts responses in Midwestern American individuals. Am J Clin Nutr. 2019 Jul 1;110(1):63-75. doi: 10.1093/ajcn/nqz028. Erratum In: Am J Clin Nutr. 2019 Sep 1;110(3):783.

• Responsible Party: Heidi Nelson, M.D., Mayo Clinic
• ClinicalTrials.gov Identifier: NCT02945514
• Other Study ID Numbers: 16-005208
• First Posted: October 26, 2016
• Last Update Posted: February 28, 2018
• Last Verified: February 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

Keywords provided by Heidi Nelson, Mayo Clinic:

Healthy; Diet; Microbiome; Personalized; Custom