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Dietary Intervention for Healthy Habits and Diet
N/A
Recruiting
Led By Tim Spector, 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
Must not have
Have had a heart attack (myocardial infarction), stroke/transient ischemic attack (TIA), or major surgery in the last two months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time frame: 12 months: baseline, daily (0 to 4 weeks), monthly (5 to 52 weeks)
Awards & highlights
No Placebo-Only Group
Summary
This trial will help to refine machine learning models that predict individual responses to foods, in order to advance precision nutrition science and individualized dietary advice.
Who is the study for?
The trial is for adults who are part of the ZOE testing program, have a BMI of at least 16.5 kg/m2, and live in the continental US (excluding New York) or UK. They must be able to follow the study protocol and give informed consent. Those with chronic conditions should consult their doctor before joining.
What is being tested?
This study tests how different foods affect individuals by using machine learning models to predict responses to diet. Participants will undergo controlled dietary interventions and record their meals during a free-living period to assess various factors' impact on post-meal responses.
What are the potential side effects?
Since this is a dietary intervention trial focusing on normal food consumption patterns, no specific side effects are expected beyond typical food-related reactions such as allergies or intolerances that participants may already be aware of.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not had a heart attack, stroke/TIA, or major surgery in the last two months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ time frame: 12 months: baseline, weekly (0 to 4 weeks), monthly (5 to 52 weeks)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time frame: 12 months: baseline, weekly (0 to 4 weeks), monthly (5 to 52 weeks)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Blood Lipids
Glucose
Glucose and HbA1c
+2 moreSecondary study objectives
Anthropometry
Bowel Type and Habit
Covid-19 symptom assessment
+2 moreOther study objectives
Adherence (in sub-cohort)
Bowel Frequency (in sub-cohort)
Bristol Stool Category (in sub-cohort)
+5 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Dietary InterventionExperimental Treatment1 Intervention
Dietary intervention using standardized test meals after which the postprandial metabolic response is measured.
Find a Location
Who is running the clinical trial?
Zoe Global LimitedLead Sponsor
9 Previous Clinical Trials
11,202,078 Total Patients Enrolled
1 Trials studying Obesity
1,139 Patients Enrolled for Obesity
Massachusetts General HospitalOTHER
3,015 Previous Clinical Trials
13,059,360 Total Patients Enrolled
74 Trials studying Obesity
42,534 Patients Enrolled for Obesity
Stanford UniversityOTHER
2,474 Previous Clinical Trials
17,251,940 Total Patients Enrolled
70 Trials studying Obesity
20,194 Patients Enrolled for Obesity
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your body mass index (BMI) is 16.5 or higher.You are currently participating in the ZOE testing program for commercial purposes.I cannot safely eat standard US meals due to allergies or recent surgery.I have not had a heart attack, stroke/TIA, or major surgery in the last two months.You have a body mass index (BMI) of 16.5 or higher.You live in the continental US, except New York, or in the UK.I am at least 18 years old, or 19 if living in Alabama or Nebraska.You are able and willing to comply with the study protocol and provide informed consent.My sex does not affect my eligibility.
Research Study Groups:
This trial has the following groups:- Group 1: Dietary Intervention
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.
Obesity Patient Testimony for trial: Trial Name: NCT04735835 — N/A
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