Status:
COMPLETED
ZOE METHOD Study: Comparing Personalized vs. Generalized Nutrition Guidelines
Lead Sponsor:
Zoe Global Limited
Collaborating Sponsors:
Massachusetts General Hospital
Stanford University
Conditions:
Personalized Nutrition
Eligibility:
All Genders
40-70 years
Phase:
NA
Brief Summary
The ZOE Method Study will test the efficacy of personalized nutritional advice, delivered on an individual level through a digital device app; integrating dietary, lifestyle, physiological and metagen...
Detailed Description
Personalized nutrition strategies offer potential for targeted dietary treatment and prevention of diet-related disease, and may ultimately serve as a powerful basis for stratified nutrition approache...
Eligibility Criteria
Inclusion
- Aged 40-70 years
- Any sex
- Waist circumference greater than ethnic- and sex-specific 25th percentile values:
- Male
- Hispanic \> 96.3cm
- Asian \> 87.3cm
- Black \> 92.7cm
- White \> 96.9cm Female
- Hispanic \> 90.7cm
- Asian \> 80.9cm
- Black \> 92.9cm
- White \> 88.3cm
- Fruit and vegetable intake below 450g/day (equivalent to 3 cups/day)
- Willing to comply with study protocol
- Live in the continental US, Hawaii or Alaska, and not in New York State (due to governmental regulations pertaining to dried blood spot testing).
- Do not meet any of the exclusion criteria
Exclusion
- Have taken part in the ZOE product or any PREDICT study beforehand.
- Are unable to read and write in English, as the ZOE app is only available in English.
- Do not complete the first Quest visit successfully
- Have an iOS/Android device not compatible with app
- Use medications affecting lipids (lipid lowering drugs e.g statins, anti-diabetic medications, e.g metformin and insulin), supplements including fish oil (unless willing to safely come off these for 4 weeks before the start of the study, and for the duration of study);
- Have ongoing inflammatory disease e.g rheumatoid arthritis, systemic lupus erythematosus, polymyalgia and other connective tissue diseases.
- Have had cancer in the last three years, excluding skin cancer.
- Have chronic gastrointestinal disorders including inflammatory bowel disease (IBD) or Celiac disease (gluten allergy), but not including irritable bowel syndrome (IBS).
- Are taking the following daily medications: immunosuppressants, corticosteroids, antibiotics in the last three months, not including inhalers.
- Are users of prescription proton pump inhibitors (PPIs) (such as omeprazole and pantoprazol), unless they are able to stop two weeks before the start of the study and remain off them for the entire duration of the study (provided their treating physician deems it safe for them to do so).
- Are currently suffering from acute clinically diagnosed depression or anxiety disorder.
- Have had a heart attack (myocardial infarction) or stroke in the last 6 months.
- Are pregnant or planning pregnancy in next 12 months, or are breastfeeding
- Are vegan, have an eating disorder or unwilling to take foods that are part of the study.
- Have an allergy to adhesives which would prevent proper attachment of the continuous glucose monitor.
Key Trial Info
Start Date :
April 4 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 8 2023
Estimated Enrollment :
347 Patients enrolled
Trial Details
Trial ID
NCT05273268
Start Date
April 4 2022
End Date
September 8 2023
Last Update
September 8 2025
Active Locations (1)
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1
ZOE Ltd
Boston, Massachusetts, United States, 02111