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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02945514
Recruitment Status : Completed
First Posted : October 26, 2016
Last Update Posted : February 28, 2018
Sponsor:
Collaborator:
DayTwo
Information provided by (Responsible Party):
Heidi Nelson, Mayo Clinic

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

Condition or disease Intervention/treatment
Healthy Volunteers Other: DayTwo machine learning algorithm

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 Design
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Study Type : Observational
Actual Enrollment : 327 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation of the Measurement and Prediction of the Postprandial Glycemic Response to Food and Providing Personally Tailored Dietary Recommendations
Study Start Date : September 2016
Actual Primary Completion Date : February 27, 2018
Actual Study Completion Date : February 28, 2018
Groups and Cohorts
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Intervention Details:
  • Other: 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

Outcome Measures
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Primary Outcome Measures :
  1. Postprandial blood sugar level [ Time Frame: Baseline through 7 days ]

Biospecimen Retention:   Samples With DNA
Whole blood and Stool

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Men and women above 18 years of age.
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.)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02945514


Locations
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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55902-9823
Sponsors and Collaborators
Mayo Clinic
DayTwo
Investigators
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Principal Investigator: Heidi Nelson, M.D. Mayo Clinic
More Information
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Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Heidi Nelson, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT02945514    
Other Study ID Numbers: 16-005208
First Posted: October 26, 2016    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Heidi Nelson, Mayo Clinic:
Healthy
Diet
Microbiome
Personalized
Custom