Providing Personally Tailored Dietary Suggestions Using Individual Microbiome and Glycemic Index Response.
NCT ID: NCT02945514
Last Updated: 2018-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
327 participants
OBSERVATIONAL
2016-09-30
2018-02-28
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.)
18 Years
ALL
Yes
Sponsors
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DayTwo
INDUSTRY
Mayo Clinic
OTHER
Responsible Party
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Heidi Nelson
M.D.
Principal Investigators
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Heidi Nelson, M.D.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic
Rochester, Minnesota, United States
Countries
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References
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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.
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.
Other Identifiers
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16-005208
Identifier Type: -
Identifier Source: org_study_id
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