Clinical trial NCT02945514: Providing Personally Tailored Dietary Suggestions Using Individual Microbiome and Glycemic Index Response.
Official title: Validation of the Measurement and Prediction of the Postprandial Glycemic Response to Food and Providing Personally Tailored Dietary Recommendations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Volunteers
Keywords: Healthy
Diet
Microbiome
Personalized
Custom
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: DayTwo
First posted: 2016-10-26
Enrollment: 327
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men and women above 18 years of age.

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

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.

Eligibility 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.)

Primary outcomes:
measure: Postprandial blood sugar level
timeFrame: Baseline through 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Heidi Nelson, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.