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ZOE METHOD Study: Comparing Personalized vs. Generalized Nutrition Guidelines

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05273268
Recruitment Status : Recruiting
First Posted : March 10, 2022
Last Update Posted : September 8, 2022
Sponsor:
Collaborators:
Massachusetts General Hospital
Stanford University
Harvard School of Public Health (HSPH)
King's College London
Information provided by (Responsible Party):
Zoe Global Limited

Brief 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).

Condition or disease Intervention/treatment Phase
Personalized Nutrition Other: Personalized nutrition Other: Generalized nutrition Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A randomised control trial with two parallel arms.
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: ZOE METHOD Study: Measuring Efficacy THrough Outcomes of Diet
Actual Study Start Date : April 4, 2022
Estimated Primary Completion Date : April 30, 2023
Estimated Study Completion Date : April 30, 2023

Arm Intervention/treatment
Active Comparator: Control Arm
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.
Other: Generalized nutrition
General nutrition guidelines currently used by USDA.

Experimental: Intervention Arm
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.
Other: Personalized nutrition
Personalized nutrition based on individual traits delivered through mobile device app.




Primary Outcome Measures :
  1. Fasted blood lipids [ Time Frame: 12 months (0 wk, 1 wk, 13 wk, 19 wk, 8mo, 12mo) ]
    Fasted measurement of triglycerides and LDL-cholesterol (mmol/L) by venous blood draw.


Secondary Outcome Measures :
  1. Body weight [ Time Frame: 12 months (0 wk, 1 wk, 7 wk, 13 wk, 19 wk, 8mo, 12mo) ]
    Body weight (kg)

  2. Waist circumference [ Time Frame: 12 months (0 wk, 1 wk, 7 wk, 13 wk, 19 wk, 8mo, 12mo) ]
    Waist circumference (cm)

  3. Hip circumference [ Time Frame: 12 months (0 wk, 1 wk, 7 wk, 13 wk, 19 wk, 8mo, 12mo) ]
    Hip circumference (cm).

  4. Blood pressure [ Time Frame: 12 months (0 wk, 1 wk, 7 wk, 13 wk, 19 wk, 8mo, 12mo) ]
    Measurement by clinical and home-based device (mmHg).

  5. HbA1c [ Time Frame: 12 months (0 wk, 19 wk, 8mo, 12mo) ]
    Fasted measurement by venous blood draw (%).

  6. Insulin [ Time Frame: 12 months (0 wk, 1 wk, 13 wk, 19 wk, 8mo, 12mo) ]
    Fasted measurement by venous blood draw (IU/L).

  7. Glucose [ Time Frame: 12 months (0 wk, 1 wk, 13 wk, 19 wk, 8mo, 12mo) ]
    Fasted measurement by venous blood draw (mmol/L).

  8. C-peptide [ Time Frame: 12 months (0 wk, 19 wk, 8mo, 12mo) ]
    Fasted measurement by venous blood draw (mmol/L).

  9. Apo-B and Apo-A [ Time Frame: 12 months (0 wk, 19 wk, 8mo, 12mo) ]
    Fasted measurement by venous blood draw (mmol/L).

  10. Gut microbiome health [ Time Frame: 12 months (0 wk, 1 wk, 13 wk, 19 wk, 8mo, 12mo) ]
    Gut microbiome assessment from stool sample for species richness and diversity.

  11. Postprandial triglyceride level [ Time Frame: 19 weeks (1 wk, 19 wk) ]
    Measured at 6 hours following a breakfast-lunch test meal challenge (intervention only; mmol/L).

  12. Habitual diet quality [ Time Frame: 12 months (1 wk, 13 wk, 19 wk, 8 mo, 12 mo) ]
    Self-reported habitual diet quality assessed by food frequency questionnaire.

  13. Energy level [ Time Frame: 12 months (1 wk, 7 wk, 13 wk, 19 wk, 8 mo, 12 mo) ]
    Self-reported energy level by questionnaire.


Other Outcome Measures:
  1. Glycemic control (Intervention arm only) [ Time Frame: 19 weeks (1 wk, 19 wk) ]
    Glucose time in range and postprandial continuous glucose quantification, derived from continuous glucose sensor used in Intervention Arm only.

  2. hsCRP [ Time Frame: 12 months (0 wk, 1 wk, 13 wk, 19 wk, 8mo, 12mo) ]
    hsCRP quantification in fasted venous blood draw (mmol/L).

  3. Glycan markers [ Time Frame: 19 weeks (1 wk, 19 wk) ]
    Glycan quantification in fasted dried blood spot tests.

  4. Skin quality [ Time Frame: 12 months (1 wk, 7 wk, 13 wk, 19 wk, 8 mo, 12 mo) ]
    Self-reported by questionnaire.

  5. Mood [ Time Frame: 12 months (1 wk, 7 wk, 13 wk, 19 wk, 8 mo, 12 mo) ]
    Self-reported by questionnaire.

  6. Hunger [ Time Frame: 12 months (1 wk, 7 wk, 13 wk, 19 wk, 8 mo, 12 mo) ]
    Self-reported by questionnaire.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 not including irritable bowel syndrome (IBS).
  • Are taking the following daily medications: immunosuppressants, corticosteroids, antibiotics in the last three months, not including inhalers.
  • Are users of prescription proton pump inhibitors (PPIs) (such as omeprazole and pantoprazol), unless they are able to stop two weeks before the start of the study and remain off them for the entire duration of the study (provided their treating physician deems it safe for them to do so).
  • Are currently suffering from acute clinically diagnosed depression or anxiety disorder.
  • Have had a heart attack (myocardial infarction) or stroke in the last 6 months.
  • Are pregnant or planning pregnancy in next 12 months, or are breastfeeding
  • Are vegan, have an eating disorder or unwilling to take foods that are part of the study.
  • Have an allergy to adhesives which would prevent proper attachment of the continuous glucose monitor.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05273268


Contacts
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Contact: Meaghan Reardon 866-771-7478 meaghan@joinzoe.com
Contact: Dan Sleeper 866-771-7478 dan@joinzoe.com

Locations
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United States, Massachusetts
ZOE Ltd Recruiting
Boston, Massachusetts, United States, 02111
Contact: Meaghan Reardon    888-255-6904    meaghan@joinzoe.com   
Sponsors and Collaborators
Zoe Global Limited
Massachusetts General Hospital
Stanford University
Harvard School of Public Health (HSPH)
King's College London
Investigators
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Principal Investigator: Sarah E Berry, PhD King's College London and consultant at ZOE Ltd
Principal Investigator: Tim Spector, Pr King's College London and consultant at ZOE Ltd
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Responsible Party: Zoe Global Limited
ClinicalTrials.gov Identifier: NCT05273268    
Other Study ID Numbers: ZOE METHOD Study
First Posted: March 10, 2022    Key Record Dates
Last Update Posted: September 8, 2022
Last Verified: February 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zoe Global Limited:
Gut microbiome
Personalized nutrition
Machine learning
Postprandial metabolism
Metabolic health