Healthy VolunteersNCT02945514
Providing Personally Tailored Dietary Suggestions Using Individual Microbiome and Glycemic Index Response.
An observational study of Healthy Volunteers, run by Mayo Clinic at 1 site in United States.
Trial summary
Provide personally tailored dietary suggestions to participants based on the Personalized Prediction Engine (patent pending) owned by DayTwo. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- DayTwo machine learning algorithm
- How many people
- 327 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to 28 Feb 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Men and women above 18 years of age.
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy Volunteers
- Being tested
- DayTwo machine learning algorithm
- Keywords
- Healthy, Diet, Microbiome, Personalized, Custom
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DayTwo machine learning algorithmOther
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial blood sugar level
Measured: Baseline through 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2016 (estimated)
- Study startSep 2016
- Primary completion27 Feb 2018
- Study completion28 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 327 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- DayTwo
- Responsible party
- Principal investigator, Heidi Nelson, Mayo Clinic
- Investigators
- Heidi Nelson, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02945514
- Sponsor's protocol ID
- 16-005208
- Status last verified
- Feb 2018
- First submitted
- 24 Oct 2016
- Last updated
- 28 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Zeevi D, Korem T, Zmora N, Israeli D, Rothschild D, Weinberger A, Ben-Yacov O, Lador D, Avnit-Sagi T, Lotan-Pompan M, Suez J, Mahdi JA, Matot E, Malka G, Kosower N, Rein M, Zilberman-Schapira G, Dohnalova L, Pevsner-Fischer M, Bikovsky R, Halpern Z, Elinav E, Segal E. Personalized Nutrition by Prediction of Glycemic Responses. Cell. 2015 Nov 19;163(5):1079-1094. doi: 10.1016/j.cell.2015.11.001.
PubMed 26590418Mendes-Soares H, Raveh-Sadka T, Azulay S, Ben-Shlomo Y, Cohen Y, Ofek T, Stevens J, Bachrach D, Kashyap P, Segal L, Nelson H. Model of personalized postprandial glycemic response to food developed for an Israeli cohort predicts responses in Midwestern American individuals. Am J Clin Nutr. 2019 Jul 1;110(1):63-75. doi: 10.1093/ajcn/nqz028.
PubMed 31095300
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Measurement and Prediction of the Postprandial Glycemic Response to Food and Providing Personally Tailored Dietary Recommendations
- ClinicalTrials.gov ID
- NCT02945514
- Acronym / sponsor ID
- 16-005208
- Conditions
- Healthy Volunteers
- Keywords
- Healthy, Diet, Microbiome, Personalized, Custom
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 327 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- DayTwo
- Study start
- Sep 2016
- Primary completion
- 27 Feb 2018 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 26 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Men and women above 18 years of age.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DayTwo machine learning algorithmPersonally 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 | Other | – |
Primary outcome
Postprandial blood sugar level
Time frame: Baseline through 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2018.
- Background: PubMed 26590418Zeevi D, Korem T, Zmora N, Israeli D, Rothschild D, Weinberger A, Ben-Yacov O, Lador D, Avnit-Sagi T, Lotan-Pompan M, Suez J, Mahdi JA, Matot E, Malka G, Kosower N, Rein M, Zilberman-Schapira G, Dohnalova L, Pevsner-Fischer M, Bikovsky R, Halpern Z, Elinav E, Segal E. Personalized Nutrition by Prediction of Glycemic Responses. Cell. 2015 Nov 19;163(5):1079-1094. doi: 10.1016/j.cell.2015.11.001.
- Derived from this study: PubMed 31095300Mendes-Soares H, Raveh-Sadka T, Azulay S, Ben-Shlomo Y, Cohen Y, Ofek T, Stevens J, Bachrach D, Kashyap P, Segal L, Nelson H. Model of personalized postprandial glycemic response to food developed for an Israeli cohort predicts responses in Midwestern American individuals. Am J Clin Nutr. 2019 Jul 1;110(1):63-75. doi: 10.1093/ajcn/nqz028.
- Click here for more information about this study: Validation Study of measurement and prediction of the postprandial glycemic response to food and providing personally tailored dietary informationLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heidi Nelson, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Volunteers, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postprandial blood sugar level (time frame: Baseline through 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02945514, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2018.