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

Completed

• Conditions: Healthy Volunteers

• Registration Number: NCT02945514
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-10-24
• Study First Submitted QC: 2016-10-24
• Study First Posted: 2016-10-26
• Status Verified: 2018-02
• Primary Completion: 2018-02-27
• Last Update Submitted: 2018-02-27
• Study Completion: 2018-02-28
• Last Update Posted: 2018-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 327

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.)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postprandial blood sugar level	Baseline through 7 days

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States