MoodZHS-FENCT06082778
ZOE's Ferment Experiment
A study testing Fermented food intake above habitual level in people with Mood and Hunger, run by Zoe Global Limited at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Fermented food intake above habitual level
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Oct 2023to 6 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Show all 10Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Eating Alive: ZOE's Ferment Experiment
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.
Read the 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.
- Being tested
- Fermented food intake above habitual level
- Keywords
- Energy, Fermented Foods, Hunger
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fermented food intake above habitual levelBehavioural
Participants increase their habitual intake of fermented foods by three portions per day, compared to their habitual intake level at baseline.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Fermented food intake above habitual level |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 weeks
Secondary outcomes (5)
Daily sensation of abdominal bloating
Participants will self-report their severity of abdominal bloating daily using a Visual Analogue Scale ranging from 0 to 10. Higher scores represent worse outcomes.
Measured: 3 weeks
Change in mood
Participants 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'.
Measured: 3 weeks
Daily level of mood
Participants will self-report their mood daily, using a Visual Analogue Scale ranging from 0 to 10. Higher scores represent better outcomes.
Measured: 3 weeks
Change in hunger level
Participants 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'.
Measured: 3 weeks
Daily hunger level
Participants will self-report their hunger level daily, using a Visual Analogue Scale ranging from 0 to 10. Higher scores represent worse outcomes.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2023
- Study start9 Oct 2023
- Primary completion6 Nov 2023 (estimated)
- Study completion6 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MoodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zoe Global Limited
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tim Spector, Pr, Principal investigator, Zoe LtdWill Bulsiewicz, Dr, Principal investigator, Zoe Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06082778
- Sponsor's protocol ID
- ZHS-FE
- Acronym
- ZHS-FE
- Status last verified
- Oct 2023
- First submitted
- 7 Oct 2023
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eating Alive: ZOE's Ferment Experiment
- ClinicalTrials.gov ID
- NCT06082778
- Acronym / sponsor ID
- ZHS-FE / ZHS-FE
- Keywords
- Energy, Fermented Foods, Hunger
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50,000 participants (estimated)
- Lead sponsor
- Zoe Global LimitedUniversity, hospital or other
- Study start
- 9 Oct 2023 (actual)
- Primary completion
- 6 Nov 2023 (estimated)
- Study completion
- 6 Nov 2023 (estimated)
- First posted
- 13 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Increased fermented food intake | Experimental | Behavioral: Fermented food intake above habitual levelParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- All adults aged 18
- Able to give informed consent
- Are participants of the ZOE Health Study
- Reside in the UK.
- Below the age of 18 years.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fermented food intake above habitual levelParticipants increase their habitual intake of fermented foods by three portions per day, compared to their habitual intake level at baseline. | Behavioural | Increased fermented food intake |
Primary outcome
Daily energy level
Time frame: 3 weeks
Participants will self-report their energy level daily using a Visual Analogue Scale ranging from 0 to 10. Higher scores represent better outcomes.
5 secondary outcomes
Daily sensation of abdominal bloating
Time frame: 3 weeks
Change in mood
Time frame: 3 weeks
Daily level of mood
Time frame: 3 weeks
Change in hunger level
Time frame: 3 weeks
Daily hunger level
Time frame: 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tim Spector, Pr principal investigator
Zoe Ltd
Will Bulsiewicz, Dr principal investigator
Zoe Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fermented food intake above habitual level in people with Mood and Hunger, run by Zoe Global Limited at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily energy level (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2023.