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

February 27, 2018 updated by: Heidi Nelson, Mayo Clinic

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

327

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55902-9823
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Men and women above 18 years of age.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Postprandial blood sugar level
Time Frame: Baseline through 7 days
Baseline through 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

DayTwo

Investigators

  • Principal Investigator: Heidi Nelson, M.D., Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Actual)

February 27, 2018

Study Completion (Actual)

February 28, 2018

Study Registration Dates

First Submitted

October 24, 2016

First Submitted That Met QC Criteria

October 24, 2016

First Posted (Estimate)

October 26, 2016

Study Record Updates

Last Update Posted (Actual)

February 28, 2018

Last Update Submitted That Met QC Criteria

February 27, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 16-005208

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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