CompletedNot Applicable

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 range

40 Years – 70 Years

Sex

ALL

See this in plain English?

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Fasted blood lipids

Timeframe: 12 months (0 wk, 1 wk, 13 wk, 19 wk, 8mo, 12mo)

Trial details

NCT IDNCT05273268

SponsorZoe Global Limited

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-09-08

View on ClinicalTrials.gov More Personalized Nutrition trials