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ZOE METHOD Study: Comparing Personalized vs. Generalized Nutrition Guidelines
N/A
Waitlist Available
Led By Sarah E Berry, PhD
Research Sponsored by Zoe Global Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months (0 wk, 1 wk, 7 wk, 13 wk, 19 wk, 8mo, 12mo)
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a smartphone app that gives personalized diet advice to generally healthy adults in the US. The app uses data on eating habits, lifestyle, and health markers to suggest the best foods for each person. The goal is to see if this personalized advice can help prevent heart and metabolic diseases better than general diet guidelines.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months (0 wk, 1 wk, 7 wk, 13 wk, 19 wk, 8mo, 12mo)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months (0 wk, 1 wk, 7 wk, 13 wk, 19 wk, 8mo, 12mo)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Lipid Bilayers
Secondary study objectives
Apo-B and Apo-A
Blood pressure
Body weight
+10 moreOther study objectives
Glycan markers
Glycemic control (Intervention arm only)
Hunger
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention ArmExperimental Treatment1 Intervention
The intervention arm (target enrollment; n=180) will receive personalized dietary guidelines created by machine learning algorithms using their personal anthropometric, gut, dietary and medical information as inputs. The guidelines will be delivered in the form of a smartphone/ smart device app.
Group II: Control ArmActive Control1 Intervention
The control arm (target enrollment; n=180) will receive the US government-standard guidelines for dietary advice in the form of the USDA dietary recommendations digital leaflet.
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Who is running the clinical trial?
Zoe Global LimitedLead Sponsor
9 Previous Clinical Trials
11,451,718 Total Patients Enrolled
Stanford UniversityOTHER
2,484 Previous Clinical Trials
17,515,761 Total Patients Enrolled
King's College LondonOTHER
761 Previous Clinical Trials
26,129,949 Total Patients Enrolled
Massachusetts General HospitalOTHER
3,023 Previous Clinical Trials
13,317,589 Total Patients Enrolled
Harvard School of Public Health (HSPH)OTHER
280 Previous Clinical Trials
14,121,240 Total Patients Enrolled
Sarah E Berry, PhDPrincipal InvestigatorKing's College London and consultant at ZOE Ltd
1 Previous Clinical Trials
80 Total Patients Enrolled
Tim Spector, PrPrincipal InvestigatorKing's College London and consultant at ZOE Ltd
3 Previous Clinical Trials
200,399 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are taller than 87.3cm and of Asian descent.People of any gender can participate.Your waist size is larger than what is considered normal for your ethnicity and gender.Your waist size is larger than 96.3cm and you are of Hispanic descent.You are currently diagnosed with severe depression or anxiety.You had a heart attack or stroke within the past 6 months.If you are Black and your waist circumference is greater than 92.7cm.You are taking medications or supplements that affect your cholesterol or blood sugar levels. You would need to stop taking them for at least 4 weeks before the study and during the study.You have an ongoing inflammatory disease like rheumatoid arthritis, lupus, or other similar conditions affecting your connective tissues.You are of Hispanic descent and have a waist circumference greater than 90.7cm.You have long-term digestive disorders like inflammatory bowel disease or celiac disease, but not irritable bowel syndrome.You follow a vegan diet, have an eating disorder, or are unwilling to eat the specific foods required for the study.You have a waist circumference of more than 92.9cm if you are Black.You eat less than 3 cups of fruits and vegetables per day.
Research Study Groups:
This trial has the following groups:- Group 1: Control Arm
- Group 2: Intervention Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.