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

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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

Tracking Information
First Submitted Date October 24, 2016
First Posted Date October 26, 2016
Last Update Posted Date February 28, 2018
Study Start Date September 2016
Actual Primary Completion Date February 27, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 24, 2016)
Postprandial blood sugar level [ Time Frame: Baseline through 7 days ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02945514 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Whole blood and Stool
Sampling Method Non-Probability Sample
Study Population Men and women above 18 years of age.
Condition Healthy Volunteers
Intervention 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
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 27, 2018)
327
Original Estimated Enrollment
 (submitted: October 24, 2016)
500
Actual Study Completion Date February 28, 2018
Actual Primary Completion Date February 27, 2018   (Final data collection date for primary outcome measure)
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.)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02945514
Other Study ID Numbers 16-005208
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Heidi Nelson, Mayo Clinic
Study Sponsor Mayo Clinic
Collaborators DayTwo
Investigators
Principal Investigator: Heidi Nelson, M.D. Mayo Clinic
PRS Account Mayo Clinic
Verification Date February 2018