ZOE's Ferment Experiment

Study Overview
=================
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.

Official Title
-----------------
Eating Alive: ZOE's Ferment Experiment

Conditions
-----------------
Mood, Hunger, Energy

Intervention / Treatment
-----------------
* Behavioral: Fermented food intake above habitual level


Participation Criteria
=================
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: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Increased fermented food intake<br>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<br>* Participants increase their habitual intake of fermented foods by three portions per day, compared to their habitual intake level at baseline.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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'. | 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. | 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'. | 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. | 3 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Energy, Fermented Foods, Hunger