RECRUITING

Personalized Responses to Dietary Composition Trial 3

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The PREDICT 3 study will build on previous research in over 2,000 individuals to further refine machine learning models that predict individual responses to foods, with the aim of advancing precision nutrition science and individualized dietary advice. The study incorporates both standardized and controlled dietary intervention, for the purpose of testing postprandial responses to specific mixed meals, in addition to a free-living period with a dietary record for measuring responses to a large variety of meals consumed in a realistic context, where the role of external factors (e.g. exercise, sleep, time of day) on postprandial responses may be determined. For the first time this PREDICT study is built on top of a commercial product which will allow access to a much larger group of participants who are already collecting large amounts of data through digital and biochemical devices that can contribute to science.

Official Title

Personalized Responses to Dietary Composition Trial 3

Quick Facts

Study Start:2020-07-20
Study Completion:2024-12-20
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04735835

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Enrolled in the commercial ZOE testing program
  2. * Any sex
  3. * Minimum 18 years of age (minimum 19 years of age in Alabama and Nebraska due to state laws)
  4. * Body mass index (BMI) of greater than or equal to 16.5 kg/m2.
  5. * Living in the continental US states, other than in New York (excluded from the ZOE testing product also as they are unable to access the dried blood spot service provided by Quest), or living in the UK
  6. * Able and willing to comply with the study protocol and provide informed consent.
  7. * Under care for chronic medical conditions (including eating disorders, type 1 diabetes, type 2 diabetes), and confirm they have checked with their primary care physician that this study is safe for them (US cohort only)
  1. * Cannot safely eat the pre-made test meals which contain standard US ingredients, e.g. due to allergy or recent gastrointestinal surgery, or are unwilling to consume these foods.
  2. * Are pregnant.
  3. * Have had a heart attack (myocardial infarction), stroke/transient ischemic attack (TIA), or major surgery in the last two months.
  4. * Are unable to read and write in English, as the ZOE app is only available in English.

Contacts and Locations

Study Contact

Meaghan Reardon
CONTACT
866-771-7478
meaghan@joinzoe.com
Dan Sleeper
CONTACT
866-771-7478
dan@joinzoe.com

Principal Investigator

Tim Spector, PhD
PRINCIPAL_INVESTIGATOR
Zoe Global Limited

Study Locations (Sites)

Zoe US Inc.
Needham, Massachusetts, 02494
United States

Collaborators and Investigators

Sponsor: Zoe Global Limited

  • Tim Spector, PhD, PRINCIPAL_INVESTIGATOR, Zoe Global Limited

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-07-20
Study Completion Date2024-12-20

Study Record Updates

Study Start Date2020-07-20
Study Completion Date2024-12-20

Terms related to this study

Keywords Provided by Researchers

  • Gut microbiome
  • Personalised nutrition
  • Machine learning
  • Postprandial metabolism
  • Metabolic health

Additional Relevant MeSH Terms

  • Diabetes
  • Heart Diseases
  • Diet Habit
  • Diet Modification
  • Healthy
  • Obesity
  • Metabolism
  • Microbial Colonization