ZOE Health Study: The Intermittent Fasting Study

NCT05558423 | Unknown

• 1 other identifier: ZHS-IF
• Study Type: interventional
• Target: 150,000
• Locations: 1 country
• Sites: 1

Brief Summary

The timing of food intake (chrononutrition) is emerging as a key regulator of circadian rhythm in metabolic organs. A wealth of research has been conducted on intermittent fasting, and time restricted eating (TRE) specifically, investigating the temporal patterns of diet (eating window, time of eating, time of largest energy intake) and their impact on disease risk, with overall beneficial impact on health. Studies have been conducted in a parallel or single arm design, while cross-over and the efficacy of TRE in ameliorating appetite and symptom burden within an individual remains unclear.

Conditions

Intermittent Fasting; Time Restricted Feeding

Keywords

Intermittent Fasting; Time Restricted Eating; Hunger; Mood; Energy

Outcome Measures

Primary Outcomes (6)

• TRE window clock time

  The chosen clock time for the TRE window (early, vs. middle, vs. late)

  2 weeks

• Habitual eating window clock time

  The chosen clock time for the habitual eating window

  1 weeks

• Hunger

  Hunger levels reported by visual analogue scale ("how hungry did you feel yesterday?"; 0-10; where 10 is the most hungry)

  3 weeks (plus optional unlimited weeks)

• Mood

  Mood levels reported by visual analogue scale ("how was your mood yesterday?"; 0-10; where 10 is most positive)

  3 weeks (plus optional unlimited weeks)

• Energy

  Energy levels reported by visual analogue scale ("how energetic did you feel yesterday?"; 0-10; where 10 is most energetic)

  3 weeks (plus optional unlimited weeks)

• Symptom burden

  The self-reported symptom burden while completing both habitual and TRE phases

  3 weeks (plus optional unlimited weeks)

Secondary Outcomes (3)

• Body weight

  3 weeks (plus optional unlimited weeks)

• Gastrointestinal symptoms

  3 weeks (plus optional unlimited weeks)

• Eating habits

  3 weeks (plus optional unlimited weeks)

Study Arms (1)

Self-controlled

EXPERIMENTAL

n-of-1 design. Participants complete a baseline habitual eating phase following by an intervention TRE phase.

Behavioral: Time Restricted Eating

Interventions

Time Restricted Eating BEHAVIORAL

Participants are asked to follow a Time Restricted Eating regimen with eating window of ≤10 hours.

Self-controlled

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults of 18 years and above, where the app has been approved for download from the Apple App and Google Play stores.

You may not qualify if:

• Unable to provide written informed consent

Sponsors & Collaborators

• Zoe Global Limited: lead
• King's College London: collaborator

Study Sites (1)

ZOE Limited

London, SE1 7RW, United Kingdom

RECRUITING

MeSH Terms

Conditions

Intermittent Fasting

Condition Hierarchy (Ancestors)

Fasting; Feeding Behavior; Behavior

Study Officials

• Tim Spector, Pr

  Zoe Ltd, King's College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christina Hu

CONTACT

07950 335916; zoehealthstudy@kcl.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2022
• First Posted: September 28, 2022
• Study Start: October 24, 2022
• Primary Completion: October 24, 2023
• Study Completion: October 24, 2023
• Last Updated: November 30, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)