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
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|Condition or disease||Intervention/treatment|
|Healthy Volunteers||Other: DayTwo machine learning algorithm|
- 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|
|Actual Enrollment :||327 participants|
|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|
- 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
- Postprandial blood sugar level [ Time Frame: Baseline through 7 days ]
Biospecimen Retention: Samples With DNA
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|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|
- 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
- Under 18 years of age
- Pre-diagnosed type I or type II diabetes mellitus
- 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.)
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
|United States, Minnesota|
|Rochester, Minnesota, United States, 55902-9823|
|Principal Investigator:||Heidi Nelson, M.D.||Mayo Clinic|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Heidi Nelson, M.D., Mayo Clinic|
|Other Study ID Numbers:||
|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|