ZOE METHOD Study: Comparing Personalized vs. Generalized Nutrition Guidelines
United States347 participantsStarted 2022-04-04
Plain-language 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 metagenomic data, in improving certain cardiometabolic disease risk factors, compared to generalized nutrition advice (control).
Who can participate
Age range40 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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…