A Study to Provide Personally Tailored Dietary Suggestions Using Individual Microbiome and Glycemic Index Response
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 16-005208
- Jacksonville, Florida: 16-005208
NCT ID: NCT02945514
Sponsor Protocol Number: 16-005208
About this study
The purpose of this study is to provide personally tailored dietary suggestions to participants based on the Personalized Prediction Engine (patent pending) which identifies the microbe environment of the digestion system, and also the persons blood sugar response to eating food.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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, chemotherapy or radiation within 2 years prior to participation
- A condition preventing the following of the dietary recommendations during the study
- 4 or more alcoholic drinks per day on a regular basis or the use of recreational drugs
- A chronic medical condition, treatment, or medication that may affect glucose metabolism (HIV diagnosis, use of steroids or immunosuppressive drugs, etc.)
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Heidi Nelson, M.D. |
Closed for enrollment |
|
Jacksonville, Fla.
Mayo Clinic principal investigator Heidi Nelson, M.D. |
Closed for enrollment |
|
More information
Publications
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Elevated postprandial blood glucose levels constitute a global epidemic and a major risk factor for prediabetes and type II diabetes, but existing dietary methods for controlling them have limited efficacy. Here, we continuously monitored week-long glucose levels in an 800-person cohort, measured responses to 46,898 meals, and found high variability in the response to identical meals, suggesting that universal dietary recommendations may have limited utility. We devised a machine-learning algorithm that integrates blood parameters, dietary habits, anthropometrics, physical activity, and gut microbiota measured in this cohort and showed that it accurately predicts personalized postprandial glycemic response to real-life meals. We validated these predictions in an independent 100-person cohort. Finally, a blinded randomized controlled dietary intervention based on this algorithm resulted in significantly lower postprandial responses and consistent alterations to gut microbiota configuration. Together, our results suggest that personalized diets may successfully modify elevated postprandial blood glucose and its metabolic consequences. VIDEO ABSTRACT.
Read More on PubMed