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ZOE's Ferment Experiment

Eating Alive: ZOE's Ferment Experiment

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06082778
Acronym
ZHS-FE
Enrollment
50000
Registered
2023-10-13
Start date
2023-10-09
Completion date
2023-11-06
Last updated
2023-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Energy, Hunger, Mood

Keywords

Energy, Fermented Foods, Hunger

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.

Interventions

BEHAVIORALFermented 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.

Sponsors

Zoe Global Limited
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Participants will be excluded if they are: * 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

Design outcomes

Primary

MeasureTime frameDescription
Daily energy level3 weeksParticipants will self-report their energy level daily using a Visual Analogue Scale ranging from 0 to 10. Higher scores represent better outcomes.

Secondary

MeasureTime frameDescription
Change in mood3 weeksParticipants will self-report their mood at baseline and wk-3 using a modified version of the Visual Analogue Mood Scale (VAMS) in response to questions about specific mood states (Happy, Sad, Calm, Tense, Energetic, Sleepy). The scale ranges from 0 to 100, with higher scores representing better outcomes for 'Happy', 'Calm' and 'Energetic'; and worse outcomes for 'Sad', 'Tense' and 'Sleepy'.
Daily level of mood3 weeksParticipants will self-report their mood daily, using a Visual Analogue Scale ranging from 0 to 10. Higher scores represent better outcomes.
Change in hunger level3 weeksParticipants will self-report their hunger level at baseline and wk-3, in response to questions about specific hunger symptoms, with answer options following a Likert scale ranging from 'strongly agree' to 'strongly disagree'.
Daily hunger level3 weeksParticipants will self-report their hunger level daily, using a Visual Analogue Scale ranging from 0 to 10. Higher scores represent worse outcomes.
Daily sensation of abdominal bloating3 weeksParticipants will self-report their severity of abdominal bloating daily using a Visual Analogue Scale ranging from 0 to 10. Higher scores represent worse outcomes.

Other

MeasureTime frameDescription
Change in stool form3 weeksParticipants will self-report the most common form of their stool form at baseline and wk-3 using the Bristol Stool Form Scale. This scale ranges from 1 to 7, with lower values indicating constipation (1-2), whereas higher values (5-7) may indicate diarrhoea and urgency.
Change in bowel movements3 weeksParticipants will self-report their average frequency of bowel movements at baseline and wk-3.
Change in digestive symptoms3 weeksParticipants will self-report their commonly experienced digestive symptoms and those that they receive treatment for, at both baseline and wk-3.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026