NCT05273268

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
347

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 18, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 10, 2022

Completed
25 days until next milestone

Study Start

First participant enrolled

April 4, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 8, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 8, 2023

Completed
Last Updated

September 8, 2025

Status Verified

August 1, 2025

Enrollment Period

1.4 years

First QC Date

February 18, 2022

Last Update Submit

August 29, 2025

Conditions

Personalized Nutrition

Keywords

Gut microbiomePersonalized nutritionMachine learningPostprandial metabolismMetabolic health

Outcome Measures

Primary Outcomes (1)

  • Fasted blood lipids

    Fasted measurement of triglycerides and LDL-cholesterol (mmol/L) by venous blood draw.

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

Secondary Outcomes (13)

  • Body weight

    12 months (0 wk, 1 wk, 7 wk, 13 wk, 19 wk, 8mo, 12mo)

  • Waist circumference

    12 months (0 wk, 1 wk, 7 wk, 13 wk, 19 wk, 8mo, 12mo)

  • Hip circumference

    12 months (0 wk, 1 wk, 7 wk, 13 wk, 19 wk, 8mo, 12mo)

  • Blood pressure

    12 months (0 wk, 1 wk, 7 wk, 13 wk, 19 wk, 8mo, 12mo)

  • HbA1c

    12 months (0 wk, 19 wk, 8mo, 12mo)

  • +8 more secondary outcomes

Other Outcomes (6)

  • Glycemic control (Intervention arm only)

    19 weeks (1 wk, 19 wk)

  • hsCRP

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

  • Glycan markers

    19 weeks (1 wk, 19 wk)

  • +3 more other outcomes

Study Arms (2)

Control Arm

ACTIVE COMPARATOR

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

Intervention Arm

EXPERIMENTAL

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

Interventions

Personalized nutritionOTHER

Personalized nutrition based on individual traits delivered through mobile device app.

Intervention Arm
Generalized nutritionOTHER

General nutrition guidelines currently used by USDA.

Control Arm

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ZOE Ltd

Boston, Massachusetts, 02111, United States

Location

Related Publications (1)

  • Bermingham KM, Linenberg I, Polidori L, Asnicar F, Arre A, Wolf J, Badri F, Bernard H, Capdevila J, Bulsiewicz WJ, Gardner CD, Ordovas JM, Davies R, Hadjigeorgiou G, Hall WL, Delahanty LM, Valdes AM, Segata N, Spector TD, Berry SE. Effects of a personalized nutrition program on cardiometabolic health: a randomized controlled trial. Nat Med. 2024 Jul;30(7):1888-1897. doi: 10.1038/s41591-024-02951-6. Epub 2024 May 8.

    PMID: 38714898DERIVED

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: A randomised control trial with two parallel arms.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2022

First Posted

March 10, 2022

Study Start

April 4, 2022

Primary Completion

September 8, 2023

Study Completion

September 8, 2023

Last Updated

September 8, 2025

Record last verified: 2025-08

Locations

US(1)