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OpenTrials
Completed

NCT Number: NCT02945514

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

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

Completed

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic

Rochester, Minnesota, 55902-9823, United States

About this study

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

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

Primary outcomes

  1. Postprandial blood sugar level

    Time frame: Baseline through 7 days

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • DayTwo

Registry information

Official study title

Validation of the Measurement and Prediction of the Postprandial Glycemic Response to Food and Providing Personally Tailored Dietary Recommendations

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Oct 26, 2016
Registry last updated
Feb 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.