NCT06082778

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

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Completed
2 days until next milestone

Study Start

First participant enrolled

October 9, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 13, 2023

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 6, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 6, 2023

Completed
Last Updated

October 31, 2023

Status Verified

October 1, 2023

Enrollment Period

28 days

First QC Date

October 7, 2023

Last Update Submit

October 27, 2023

Conditions

Keywords

EnergyFermented FoodsHunger

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

EXPERIMENTAL

Participants 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.

Behavioral: Fermented food intake above habitual level

Interventions

Participants increase their habitual intake of fermented foods by three portions per day, compared to their habitual intake level at baseline.

Increased fermented food intake

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

Study Officials

  • Tim Spector, Pr

    Zoe Ltd

    PRINCIPAL INVESTIGATOR
  • Will Bulsiewicz, Dr

    Zoe Ltd

    PRINCIPAL INVESTIGATOR

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

Locations