Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT06082778 |
| Other study ID # |
ZHS-FE |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 9, 2023 |
| Est. completion date |
November 6, 2023 |
Study information
| Verified date |
October 2023 |
| Source |
Zoe Global Limited |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
