ZOE's Ferment Experiment

NCT ID: NCT06082778

Last Updated: 2023-10-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-09
• Study Completion Date: 2023-11-06

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.

Detailed Description

Background:

Fermented foods (e.g., kombucha, kimchi, sauerkraut) are living foods containing an ecosystem of bacteria and yeasts that use enzymes to process and transform food components. The process of fermentation results in an enhanced nutritional profile of these foods (including probiotics, prebiotics, and additional vitamins) which are associated with health benefits. The majority of people in the Western world consume low amounts of fermented food with live cultures; ~70% report never or rarely consuming fermented foods.

Existing research demonstrates that there are benefits to consuming fermented foods, including improvement of gut microbiome composition as well as reducing inflammation. Furthermore, fermented foods are a unique source of B vitamins that are related to energy levels. Low energy levels are a common but complex problem that affects healthy individuals as well as those with chronic health conditions. Whilst the underlying causes of low energy are unclear, they are a common complaint of many digestive disorders, autoimmune, chronic inflammatory conditions, and metabolic and mood disorders, all of which are associated with disturbance of the gut microbiome. Humans are unable to produce B vitamins and are reliant on diet or gut microbes to produce them. Vitamin B12 levels are ten fold greater in fermented dairy products, and can be found in fermented plant-based foods such as tempeh, making these foods a valuable source of vitamin B12, a nutrient that the human diet is commonly deficient in. Fermented foods may have the potential to improve energy, and mood, by increasing gut diversity and reducing inflammation.

Population:

This research is open to participants who are enrolled in the ZOE Health Study. Participants must be at least 18 years of age and must provide their consent in order to participate.

Design:

The Fermented Foods study will take place in an entirely remote format. This study will take part in two phases. Firstly, the participant will complete a habitual diet phase lasting one week, where the participant reports study outcomes while consuming their habitual diet (including habitual intake level of fermented foods). Secondly, the participant will complete the modification phase lasting two weeks, throughout which they are required to introduce, or increase, their habitual intake of fermented foods by three portions per day (e.g., where a participant normally consumes 1 serving per day, they will now be asked to consume 4 servings per day).

Using the ZOE Health Study app, participants will be asked to:

• Complete questionnaires to assess habitual food intake, dietary habits, health history, sleep, bowel habits and digestive health at the start and end of the study.
• Log levels of hunger, energy, mood and bloating, on a daily basis, throughout the entire study period (baseline and modification phase) using the study app.
• Log their portion intake of fermented foods, on a daily basis, throughout the entire study period.

Conditions

Mood; Hunger; Energy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Increased fermented food intake

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.

Group Type: EXPERIMENTAL

Fermented food intake above habitual level

Intervention Type: BEHAVIORAL

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

Interventions

Fermented food intake above habitual level

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• All adults aged 18
• Able to give informed consent
• Are participants of the ZOE Health Study
• Reside in the UK.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zoe Global Limited

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tim Spector, Pr

Role: PRINCIPAL_INVESTIGATOR

Zoe Ltd

Will Bulsiewicz, Dr

Role: PRINCIPAL_INVESTIGATOR

Zoe Ltd

Locations

ZOE Ltd

London, England, United Kingdom

Countries

United Kingdom

Other Identifiers

ZHS-FE

Identifier Type: -

Identifier Source: org_study_id