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

NCT02945514 | Completed

• 1 other identifier: 16-005208
• Study Type: observational
• Target: 327
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers

Keywords

Healthy; Diet; Microbiome; Personalized; Custom

Outcome Measures

Primary Outcomes (1)

• Postprandial blood sugar level

  Baseline through 7 days

Interventions

DayTwo machine learning algorithm OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Men and women above 18 years of age.

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.)

Sponsors & Collaborators

• Mayo Clinic: lead
• DayTwo: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55902-9823, United States

Location

Related Publications (2)

• 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.

  PMID: 26590418 BACKGROUND

• 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.

  PMID: 31095300 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood and Stool

Study Officials

• Heidi Nelson, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: October 24, 2016
• First Posted: October 26, 2016
• Study Start: September 1, 2016
• Primary Completion: February 27, 2018
• Study Completion: February 28, 2018
• Last Updated: February 28, 2018

Record last verified: 2018-02

Locations

US (1)