StressBALANCENCT07477470
BALANCE Study: Beneficial Effects of A Diverse Prebiotic Fibre bLend on Affect, iNflammation, Cognition, and the Gut microbiomE
A study testing Prebiotic fibre blend in people with Stress, run by Myota GmbH at 1 site in United Kingdom.
Trial summary
This clinical trial will investigate whether a powdered prebiotic fibre blend, at two doses, can improve perceived stress levels in healthy adults with mild-severe stress levels. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Stress
- What is being tested?
- Prebiotic fibre blend
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jun 2026to 1 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged 18-50 years of age
- Capacity to give informed consent to participate in the study
- Able to comply with study requirements and visits
- Meet the criteria for mild-severe stress levels (scores between 15-33) as assessed by DASS-42 Stress Subscale
- Normal or corrected to normal vision and/or hearing
Who cannot join
- Current smoker
- Having food allergies and/or intolerances
- Current diagnosis of Type 1 or 2 diabetes, cardiometabolic disease, or psychiatric or neurological conditions (e.g. schizophrenia, dementia) including eating disorders
- Current or previous diagnosis of depression in past 6 months
- Currently receiving medications that lower cholesterol, blood pressure, blood glucose levels, or improve insulin sensitivity
- Receiving antidepressant or anti-anxiety medications or treatments
Show all 17Show fewer
- Receiving hormonal birth control
- Perimenopause or menopause
- Pregnancy, lactation, or an intent to become pregnant during the course of the study
- Continuous antibiotic use for > 3 days within 1 month prior to enrolment
- Continuous use of weight-loss drug for > 1 month before screening
- Major change in dietary intake in past month (e.g. excluding whole food groups)
- Consuming a restricted diet, including a vegan, vegetarian, and ketogenic diet
- Currently consuming daily prebiotic or probiotic supplements
- Any significant GI condition affecting absorption including (but not limited to) inflammatory bowel disease, weight loss surgery, irritable bowel syndrome.
- Active cancer, or treatment for any cancer, in last 3 years
- Consuming more than 20g of fibre a day as assessed by the FiberScreen
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
BALANCE Study Site
London, EC2A 4BQ
Caitlin Hall, PhD, 7830709854 ext. +44, caitlin@myotahealth.com
About this study
Official title: Beneficial Effects of A Diverse Prebiotic Fibre bLend on Affect, iNflammation, Cognition, and the Gut microbiomE: a Double-blind Placebo Controlled Randomised Controlled Trial
This clinical trial will investigate whether a powdered prebiotic fibre blend, at two doses, can improve perceived stress levels in healthy adults with mild-severe stress levels.
Read the detailed description
There is growing interest in how the gut microbiota interacts with the brain to influence psychological outcomes, particularly stress. Even in otherwise healthy individuals, persistent psychological stress is associated with measurable physiological changes-including elevated cortisol levels, heightened hypothalamic-pituitary-adrenal (HPA) axis reactivity, and systemic low-grade inflammation. These biological signatures are increasingly understood to be shaped, in part, by the composition and activity of the gut microbiota.
This study will investigate how a powdered prebiotic fibre supplement can affect stress levels. Secondary endpoints include the effects that the prebiotic fibre supplement will have on other areas of health, like depression, mood, anxiety, cognition, inflammation, and the gut microbiome.
- Conditions
- Stress
- Being tested
- Prebiotic fibre blend, Maltodextrin (Placebo)
- Keywords
- gut-brain axis, perceived stress, prebiotic fibre, cognitive function, anxiety, mood, depression, inflammation
- Medical subject headings
- Anxiety Disorders, Depression, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prebiotic fibre blendDietary supplement
A blend of prebiotic fibres in a powdered supplement form.
Maltodextrin (Placebo)Dietary supplement
Maltodextrin powder
| Study group | Role | What they receive |
|---|---|---|
| Prebiotic fibre blend (6g) | Experimental | Prebiotic fibre blend, consisting of 6g of a powdered supplement, to be taken daily alongside usual Receives: Dietary Supplement: Prebiotic fibre blend |
| Prebiotic fibre blend (10g) | Experimental | Prebiotic fibre blend, consisting of 10g of a powdered supplement, to be taken daily alongside usual diet for 12 weeks. Receives: Dietary Supplement: Prebiotic fibre blend |
| Placebo | Placebo comparator | Placebo will be 10g of maltodextrin powder, to be taken daily alongside usual diet for 12 weeks. Receives: Dietary Supplement: Maltodextrin (Placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Stress
The primary objective is to determine the effect of 12-week long daily administration of Prebiotic fibre blend as compared to Placebo on stress scores (Perceived Stress Scale) on a scale between 0 - 40 (where higher scores indicate higher stress).
Measured: Baseline and 12 weeks
Secondary outcomes (11)
Perceived Stress
To determine the effect of 12-week long daily administration of Prebiotic fibre blend as compared to Placebo on stress scores (Perceived Stress Scale) on a scale between 0 - 40 (where higher scores indicate higher stress).
Measured: Baseline and 8 weeks
Depression
To determine the effect of 12-week daily administration of Prebiotic fibre blend as compared to Placebo on depression scores (PHQ-8), on a scale between 0 - 24 (where higher scores mean higher depression).
Measured: Baseline, 8 weeks and 12 weeks
Mood
To determine the effect of 12-week daily administration of Prebiotic fibre blend as compared to Placebo on mood scores (PANAS-X), on a scale between 10 - 50 (where higher scores on the Positive Affect scale indicate higher levels of positive engagement with your environment; while higher scores on the Negative Affect scale indicate higher levels of negative engagement).
Measured: Baseline, 8 weeks and 12 weeks
Anxiety
To determine the effect of 12-week daily administration of Prebiotic fibre blend as compared to Placebo on anxiety scores (GAD-7), on a scale between 0 - 21 (where higher scores mean higher anxiety levels).
Measured: Baseline, Week 8, and Week 12
Serum hs-CRP
To determine the effect of 12-week daily administration of Prebiotic fibre blend as compared to Placebo on serum high sensitivity C-Reactive Protein (hs-CRP).
Measured: Baseline and Week 12
Cognition: Auditory Verbal Learning Task (AVLT)
To determine the effect of 12-week daily administration of Prebiotic fibre blend as compared to Placebo on immediate and delayed word recognition, as assessed by the AVLT where better scores are achieved by higher number or recalled words and lower error rate.
Measured: Baseline and Week 12
Cognition: Affective 2-Back Task
To determine the effect of 12-week daily administration of Prebiotic fibre blend as compared to Placebo on emotional interference in working memory under emotional load, as assessed by the Affective 2-Back Task, where better scores are achieved by lower reaction times and higher accuracy score.
Measured: Baseline and Week 12
Cognition: Emotional Go/No-Go
To determine the effect of 12-week daily administration of Prebiotic fibre blend as compared to Placebo on emotion-related inhibitory control and response suppression, as assessed by the Emotional Go-No-Go, where better scores are achieved by higher correct response rates and lower commission errors.
Measured: Baseline and Week 12
Cognition: Attentional Network Task (ANT)
To determine the effect of 12-week daily administration of Prebiotic fibre blend as compared to Placebo on efficiency of alerting, orienting, and executive attention networks, as assessed by the Attentional Network Task, where better scores are achieved by lower reaction times and higher accuracy.
Measured: Baseline and Week 12
Cognition: Number Letter Task
To determine the effect of 12-week daily administration of Prebiotic fibre blend as compared to Placebo on cognitive flexibility and task-switching ability, as assessed by the Number Letter Task where better scores are achieved by a higher accuracy of recalled sequences.
Measured: Baseline and Week 12
Gastrointestinal symptoms
To determine the effect of 12-week daily administration of Prebiotic fibre blend as compared to Placebo on gastrointestinal symptoms (GSRS), on a scale of 15 - 105 where higher scores indicate more severe gastrointestinal discomfort.
Measured: Baseline, Week 8 and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start1 Jun 2026
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three-arm, double-blind, placebo-controlled randomised trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Myota GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Reading
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07477470
- Sponsor's protocol ID
- BALANCE
- Acronym
- BALANCE
- Status last verified
- Mar 2026
- First submitted
- 12 Mar 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participant data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beneficial Effects of A Diverse Prebiotic Fibre bLend on Affect, iNflammation, Cognition, and the Gut microbiomE: a Double-blind Placebo Controlled Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07477470
- Acronym / sponsor ID
- BALANCE / BALANCE
- Conditions
- Stress
- Keywords
- gut-brain axis, perceived stress, prebiotic fibre, cognitive function, anxiety, mood, depression, inflammation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Myota GmbHIndustry (pharma, biotech, devices)
- Collaborators
- University of Reading
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 17 Mar 2026 (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.
This clinical trial will investigate whether a powdered prebiotic fibre blend, at two doses, can improve perceived stress levels in healthy adults with mild-severe stress levels.
Detailed description
There is growing interest in how the gut microbiota interacts with the brain to influence psychological outcomes, particularly stress. Even in otherwise healthy individuals, persistent psychological stress is associated with measurable physiological changes-including elevated cortisol levels, heightened hypothalamic-pituitary-adrenal (HPA) axis reactivity, and systemic low-grade inflammation. These biological signatures are increasingly understood to be shaped, in part, by the composition and activity of the gut microbiota.
This study will investigate how a powdered prebiotic fibre supplement can affect stress levels. Secondary endpoints include the effects that the prebiotic fibre supplement will have on other areas of health, like depression, mood, anxiety, cognition, inflammation, and the gut microbiome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Three-arm, double-blind, placebo-controlled randomised trial
| Arm | Type | Receives |
|---|---|---|
| Prebiotic fibre blend (6g) | Experimental | Dietary Supplement: Prebiotic fibre blendPrebiotic fibre blend, consisting of 6g of a powdered supplement, to be taken daily alongside usual |
| Prebiotic fibre blend (10g) | Experimental | Dietary Supplement: Prebiotic fibre blendPrebiotic fibre blend, consisting of 10g of a powdered supplement, to be taken daily alongside usual diet for 12 weeks. |
| Placebo | Placebo comparator | Dietary Supplement: Maltodextrin (Placebo)Placebo will be 10g of maltodextrin powder, to be taken daily alongside usual diet for 12 weeks. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Aged 18-50 years of age
- Capacity to give informed consent to participate in the study
- Able to comply with study requirements and visits
- Meet the criteria for mild-severe stress levels (scores between 15-33) as assessed by DASS-42 Stress Subscale
- Normal or corrected to normal vision and/or hearing
Key exclusion criteria (17 listed)
- Current smoker
- Having food allergies and/or intolerances
- Current diagnosis of Type 1 or 2 diabetes, cardiometabolic disease, or psychiatric or neurological conditions (e.g. schizophrenia, dementia) including eating disorders
- Current or previous diagnosis of depression in past 6 months
- Currently receiving medications that lower cholesterol, blood pressure, blood glucose levels, or improve insulin sensitivity
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 |
|---|---|---|
| Prebiotic fibre blendA blend of prebiotic fibres in a powdered supplement form. | Dietary supplement | Prebiotic fibre blend (10g), Prebiotic fibre blend (6g) |
| Maltodextrin (Placebo)Maltodextrin powder | Dietary supplement | Placebo |
Primary outcome
Perceived Stress
Time frame: Baseline and 12 weeks
The primary objective is to determine the effect of 12-week long daily administration of Prebiotic fibre blend as compared to Placebo on stress scores (Perceived Stress Scale) on a scale between 0 - 40 (where higher scores indicate higher stress).
11 secondary outcomes
Perceived Stress
Time frame: Baseline and 8 weeks
Depression
Time frame: Baseline, 8 weeks and 12 weeks
Mood
Time frame: Baseline, 8 weeks and 12 weeks
Anxiety
Time frame: Baseline, Week 8, and Week 12
Serum hs-CRP
Time frame: Baseline and Week 12
Cognition: Auditory Verbal Learning Task (AVLT)
Time frame: Baseline and Week 12
Cognition: Affective 2-Back Task
Time frame: Baseline and Week 12
Cognition: Emotional Go/No-Go
Time frame: Baseline and Week 12
Cognition: Attentional Network Task (ANT)
Time frame: Baseline and Week 12
Cognition: Number Letter Task
Time frame: Baseline and Week 12
Gastrointestinal symptoms
Time frame: Baseline, Week 8 and Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: No. Participant data will not be shared.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prebiotic fibre blend in people with Stress, run by Myota GmbH 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 5 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 3 Jun 2026. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas Gurry, PhD (797908227 ext. +41, thomas@myotahealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Stress (time frame: Baseline and 12 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 3 Jun 2026.