ZOE's Ferment Experiment
ZHS-FE
Eating Alive: ZOE's Ferment Experiment
1 other identifier
interventional
50,000
1 country
1
Brief Summary
It is not known if an increase in fermented food intake relative to an individuals' habitual diet can lead to improvements in bloating, mood, or hunger levels, or increase energy levels (and reduce fatigue) in the general population. Acceptability of fermented foods across many different types of people and households is also unclear. Therefore, this research aims to investigate the potential effects of increasing fermented food intake on these outcomes, as well as the feasibility of this dietary change.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 7, 2023
CompletedStudy Start
First participant enrolled
October 9, 2023
CompletedFirst Posted
Study publicly available on registry
October 13, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 6, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 6, 2023
CompletedOctober 31, 2023
October 1, 2023
28 days
October 7, 2023
October 27, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Daily energy level
Participants will self-report their energy level daily using a Visual Analogue Scale ranging from 0 to 10. Higher scores represent better outcomes.
3 weeks
Secondary Outcomes (5)
Daily sensation of abdominal bloating
3 weeks
Change in mood
3 weeks
Daily level of mood
3 weeks
Change in hunger level
3 weeks
Daily hunger level
3 weeks
Other Outcomes (3)
Change in digestive symptoms
3 weeks
Change in bowel movements
3 weeks
Change in stool form
3 weeks
Study Arms (1)
Increased fermented food intake
EXPERIMENTALParticipants take part in a n-of-1 design. They are first required to consume their habitual diet, for one week, followed by a period of dietary advice, for two weeks.
Interventions
Participants increase their habitual intake of fermented foods by three portions per day, compared to their habitual intake level at baseline.
Eligibility Criteria
You may qualify if:
- All adults aged 18
- Able to give informed consent
- Are participants of the ZOE Health Study
- Reside in the UK.
You may not qualify if:
- Below the age of 18 years.
- Have an histamine intolerance.
- Have a compromised immune system.
- Have been instructed to follow a salt-restricted diet.
- Consume 8 or more portions of fermented foods on a daily basis at baseline
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
ZOE Ltd
London, England, SE1 7RW, United Kingdom
Study Officials
- PRINCIPAL INVESTIGATOR
Tim Spector, Pr
Zoe Ltd
- PRINCIPAL INVESTIGATOR
Will Bulsiewicz, Dr
Zoe Ltd
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
October 7, 2023
First Posted
October 13, 2023
Study Start
October 9, 2023
Primary Completion
November 6, 2023
Study Completion
November 6, 2023
Last Updated
October 31, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share