DepressionNutriMoodNCT06087471
Snack Foods and Their Impact on Mental Health and the Gut-brain Axis
A study testing Intervention snack in people with Depression and Anxiety, run by King's College London at 1 site in United Kingdom.
Trial summary
The aim of this study is to investigate the effects of snack foods on mental health and the gut-brain axis, in adults with mild to moderate symptoms of depression and anxiety. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- Intervention snack
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Oct 2023to 21 May 2024
- 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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults aged 18-45 years old.
- Body mass index (BMI) between 18.50-29.99kg/m2
- Score 10-29 on the patient health questionnaire anxiety and depression scale (PHQ-ADS) for mild to moderate symptoms of depression and anxiety.
- Individuals who regularly consume snacks (Classified as ≥2 per day excluding fruit, vegetable, nut and seed snacks).
- Willing to complete the 12-week intervention by adhering to snacks, complete mental health questionnaires, provide stool and blood samples, record weight and other anthropometric values and record food intake at various timepoints throughout the intervention.
- Willing to adhere to the protocol and provide informed consent.
- Fibre intake of <30g/d
- Willing to discontinue use of pre and probiotics during the trial.
Who cannot join
- Dislike of intervention products.
- Allergy or intolerance to the intervention products
- Self-report occurrence of substance dependency or severe mental health conditions (e.g., psychosis, schizophrenia, eating disorder). Those with depressive disorders or anxiety disorders will be included in the trial providing they meet all other inclusion criteria.
- Regular consumption of experimental product as snacks and unwilling to complete a washout (no consumption for 4 weeks before baseline or during the study period).
- Changes to medication for depression or anxiety within the last 3 months (e.g., dosage, frequency, type)
- Initiation of any new medications for mental health or any form of talk therapy within the last 3 months.
Show all 12Show fewer
- Intention to start or alter medication or therapy for mental health during the study.
- Current or previous antibiotic treatment within 4 weeks prior to the start of the study.
- Consumption of probiotics or prebiotic products within the 2 weeks prior to the start of the study
- Women who are pregnant, lactating or planning pregnancy
- Unexplained or unintentional weight loss in the past six months
- Medical history of any of the following: diabetes, major active or historic psychiatric conditions (e.g. schizophrenia), current eating disorder, alcohol abuse, active treatment for cancer in the last year, severe neurological, endocrine, renal, cardiac or pulmonary disease (or any other chronic medical condition), severe oesophagitis, gastritis or duodenitis, active diverticulitis or intestinal/colonic strictures, Coeliac disease, Crohn's disease or Ulcerative colitis, stem cell or organ transplant, gut resection surgery (excluding appendicectomy and cholecystectomy), bleeding disorder, anaphylaxis or any other major or chronic condition known to impact study outcome measures.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Metabolic research unit, Franklin-Wilkins Building, 150 stamford street
London, SE19NH
About this study
Official title: Snack Foods and Their Impact on the Gut-Brain Axis: a Randomised Controlled Trial on Mental Health and the Gut Microbiota
The aim of this study is to investigate the effects of snack foods on mental health and the gut-brain axis, in adults with mild to moderate symptoms of depression and anxiety.
Read the detailed description
There is increasing evidence on the potential modulating role of healthy dietary patterns in managing symptoms of psychological distress including but not limited to depression and anxiety. Despite growing evidence, further research is required to investigate how dietary interventions may impact symptoms of depression and anxiety, as well as their mechanisms of action via the gut-brain axis. Consumption of snacks now contributes to roughly 17% and 21% of daily energy intake for men and women respectively. Therefore, snacks greatly impact nutritional intake and diet quality and can be a target of dietary manipulation for potential health benefits.
This will be the first randomised controlled trial to assess the impact of snack consumption on mental health in adults with mild to moderate symptoms of depression and anxiety. The trial will use a parallel design with a 12-week intervention. Stool and blood samples will be collected at the beginning and end of the intervention for measurement of the gut microbiota and biomarkers related to the gut-brain axis.
- Conditions
- Depression, Anxiety
- Being tested
- Intervention snack, Control Snack
- Keywords
- Mental health, Gut-Brain Axis, Depression, Anxiety, Nutrition, Gut Microbiome
- Medical subject headings
- Depression, Anxiety Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention snackDietary supplement
The intervention snack will be consumed by 42 participants for 12-weeks. Snacks will be consumed twice a day (mid-morning and mid afternoon snack).
Control SnackDietary supplement
The control snack will be consumed by 42 participants for 12-weeks. Snacks will be consumed twice a day (mid-morning and mid afternoon snack).
| Study group | Role | What they receive |
|---|---|---|
| Control snack | Sham comparator | 42 participants will be randomly assigned to the control snack. Snacks should be consumed twice per day, once as a mid-morning snack and again as a mid-afternoon snack. Receives: Dietary Supplement: Control Snack |
| Experimental snack | Experimental | 42 participants (50%) will be randomly assigned to snack on the intervention snack. Snacks should be consumed twice per day, once as a mid-morning snack and again as a mid-afternoon snack. Receives: Dietary Supplement: Intervention snack |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms of depression and anxiety
Symptoms of depression and anxiety as measured by the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS). This is a 15-item self-report likert scale comprising the PHQ-8 and GAD-7. Scores can range from 0 to 48, cut points of 10,20 and 30 indicate mild, moderate and severe levels of depression/anxiety respectively.
Measured: Week 0 and 12
Secondary outcomes (24)
Functional impairment
The self-report Work and social adjustment scale (WSAS) will be used to measure functional impairment scores. This is a self-report likert scale with 5 questions. Responses range from Not at all (0) to Very severely (8). 0-9, 10-19 and 20-40 represent low, moderate and severe impairment respectively.
Measured: Weeks 0,6 and 12
Sleep quality
The self-report Pittsburgh sleep quality index (PSQI) will be used to measure sleep quality. This is a 19-item questionnaire with seven subcategories; subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction.
Measured: Weeks 0,6 and 12
Wellbeing
The self-report world health organisation five well-being index (WHO-5) will be used to measure wellbeing. The scale consists of 5 items rated from All of the time (5) to At no time (0).
Measured: Weeks 0,6 and 12
Quality of life
The self-report World Health Organisation Quality of Life Brief (WHOQOL-BREF) scale will be used to measure quality of life. This is a 26-item scale. Responses are rated on a 1-5 likert scale with 1 representing 'not at all' and 5 representing 'completely agree'. Scores are tabulated and multiplied by 4 to represent a score out of 100.
Measured: Weeks 0,6 and 12
Physical activity
The self-report international Physical Activity Questionnaire - Short form (IPAQ) will be used to measure physical activity.
Measured: Weeks 0,6 and 12
Symptoms of depression
The self-report Patient Health Questionnaire-8 (PHQ-8) will be used to measure symptoms of depression. The PHQ-8 is comprised of 8 items rated 0 to 3 with 0 representing 'not at all' and 3 representing 'nearly every day'.
Measured: Weeks 0,6 and 12
Symptoms of anxiety
The self-report Generalised Anxiety disorder-7 scale will be used to measure symptoms of anxiety. The GAD-7 is comprised of 7 questions rated 0 to 3 indicating not at all, to nearly every day respectively.
Measured: Weeks 0,6 and 12
Psychological Distress
The Kessler Psychological Distress Scale (K10) will be used to measure symptoms of psychological distress. The K10 is comprised of 10 questions rated on a 5-point likert scale. Scores range from 10-50.
Measured: Weeks 0,6 and 12
Faecal gut microbiota (composition, alpha- and beta-diversity)
Measured by 16S community profiling (Illumina Miseq) of bacterial genomic DNA isolated from stool samples.
Measured: Week 0 and 12
Faecal short-chain fatty acids (SCFA)
Measured by gas liquid chromatography of stool samples
Measured: Week 0 and 12
Faecal water
Determined from stool samples by oven-drying
Measured: Week 0 and 12
Gut symptoms
Measured using the Gastrointestinal Symptom Rating Scale (GSRS) (7-day diary; questionnaire)
Measured: Week 0 and 12
Stool frequency
Measured using self-reported number bowel movements daily recorded in a 7-day diary.
Measured: Week 0 and 12
Stool consistency
Measured using the Bristol stool form scale (7-day dairy; questionnaire)
Measured: Week 0 and 12
Serum Vitamin E levels
Measured in blood sample. Analysis of serum vitamin E levels by Liquid chromatography-mass spectrometry.
Measured: Week 0 and 12
Dietary intake
Measured using a 7-day food and drink diary
Measured: Week 0 and 12
Acceptability of snack products
Measured using an Acceptability of dietary intervention questionnaire developed by King's College London for use in dietary intervention studies. The questionnaire assesses acceptability using a number of domains including flavour, texture and portion size.
Measured: Week 12
Snack compliance
Measured via the return of unused snacks at the final visit (consumption of >75% of total snacks will be considered compliant).
Measured: Week 12
Adverse events
Interview-administered questionnaire
Measured: Week 0 to 12
Symptoms of depression and anxiety
Symptoms of depression and anxiety as measured by the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS). This is a 15-item self-report likert scale comprising the PHQ-8 and GAD-7. Scores can range from 0 to 48, cut points of 10,20 and 30 indicate mild, moderate and severe levels of depression/anxiety respectively.
Measured: Week 0,6 and 12
Change in symptoms of depression and anxiety
Change symptoms of depression and anxiety as measured by the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS). This is a 15-item self-report likert scale comprising the PHQ-8 and GAD-7. Scores can range from 0 to 48, cut points of 10,20 and 30 indicate mild, moderate and severe levels of depression/anxiety respectively.
Measured: Week 0, 6 and 12
Proportion of people with no, mild, moderate and severe symptoms of anxiety and depression
Measured by the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS). This is a 15-item self-report likert scale comprising the PHQ-8 and GAD-7. Scores can range from 0 to 48, cut points of 10,20 and 30 indicate mild, moderate and severe levels of depression and anxiety respectively.
Measured: Week 0, 6 and 12
Proportion of people with no, mild, moderate and severe symptoms of depression
Measured by the PHQ-8 questionnaire. Scores can range from 0 to 24, cut points of 5, 10, 15 and 20 indicate mild, moderate, moderately severe and severe levels of depression, respectively.
Measured: Week 0, 6 and 12
Proportion of people with no, mild, moderate and severe symptoms of anxiety
Measured by the GAD-7. The GAD-7 is comprised of 7 questions rated 0 to 3 indicating not at all, to nearly every day respectively and scores range from 0-21. Cut points are 5, 10 and 15 indicating mild, moderate and severe levels of anxiety, respectively.
Measured: Week 0, 6 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2023
- Study start16 Oct 2023
- Primary completion21 May 2024
- Study completion21 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06087471
- Sponsor's protocol ID
- 1423790
- Acronym
- NutriMood
- Status last verified
- Oct 2023
- First submitted
- 11 Oct 2023
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sartori L, Argomaniz N, Farsi DN, Bajka B, Chrysostomou D, Marchesi JR, Chilcot J, Whelan K, Dimidi E. Almonds and Their Impact on Mental Health and the Gut-Brain Axis in Adults with Symptoms of Anxiety and Depression: A 12-Week Randomized Controlled Trial. J Nutr. 2026 Jul 16;156(9):101732. doi: 10.1016/j.tjnut.2026.101732. Online ahead of print.
PubMed 42463057
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Snack Foods and Their Impact on the Gut-Brain Axis: a Randomised Controlled Trial on Mental Health and the Gut Microbiota
- ClinicalTrials.gov ID
- NCT06087471
- Acronym / sponsor ID
- NutriMood / 1423790
- Conditions
- Depression, Anxiety
- Keywords
- Mental health, Gut-Brain Axis, Depression, Anxiety, Nutrition, Gut Microbiome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- 16 Oct 2023 (actual)
- Primary completion
- 21 May 2024 (actual)
- Study completion
- 21 May 2024 (actual)
- First posted
- 17 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.
The aim of this study is to investigate the effects of snack foods on mental health and the gut-brain axis, in adults with mild to moderate symptoms of depression and anxiety.
Detailed description
There is increasing evidence on the potential modulating role of healthy dietary patterns in managing symptoms of psychological distress including but not limited to depression and anxiety. Despite growing evidence, further research is required to investigate how dietary interventions may impact symptoms of depression and anxiety, as well as their mechanisms of action via the gut-brain axis. Consumption of snacks now contributes to roughly 17% and 21% of daily energy intake for men and women respectively. Therefore, snacks greatly impact nutritional intake and diet quality and can be a target of dietary manipulation for potential health benefits.
This will be the first randomised controlled trial to assess the impact of snack consumption on mental health in adults with mild to moderate symptoms of depression and anxiety. The trial will use a parallel design with a 12-week intervention. Stool and blood samples will be collected at the beginning and end of the intervention for measurement of the gut microbiota and biomarkers related to the gut-brain axis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control snack | Sham comparator | Dietary Supplement: Control Snack42 participants will be randomly assigned to the control snack. Snacks should be consumed twice per day, once as a mid-morning snack and again as a mid-afternoon snack. |
| Experimental snack | Experimental | Dietary Supplement: Intervention snack42 participants (50%) will be randomly assigned to snack on the intervention snack. Snacks should be consumed twice per day, once as a mid-morning snack and again as a mid-afternoon snack. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Adults aged 18-45 years old.
- Body mass index (BMI) between 18.50-29.99kg/m2
- Score 10-29 on the patient health questionnaire anxiety and depression scale (PHQ-ADS) for mild to moderate symptoms of depression and anxiety.
- Individuals who regularly consume snacks (Classified as ≥2 per day excluding fruit, vegetable, nut and seed snacks).
- Willing to complete the 12-week intervention by adhering to snacks, complete mental health questionnaires, provide stool and blood samples, record weight and other anthropometric values and record food intake at various timepoints throughout the intervention.
Key exclusion criteria (12 listed)
- Dislike of intervention products.
- Allergy or intolerance to the intervention products
- Self-report occurrence of substance dependency or severe mental health conditions (e.g., psychosis, schizophrenia, eating disorder). Those with depressive disorders or anxiety disorders will be included in the trial providing they meet all other inclusion criteria.
- Regular consumption of experimental product as snacks and unwilling to complete a washout (no consumption for 4 weeks before baseline or during the study period).
- Changes to medication for depression or anxiety within the last 3 months (e.g., dosage, frequency, type)
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 |
|---|---|---|
| Intervention snackThe intervention snack will be consumed by 42 participants for 12-weeks. Snacks will be consumed twice a day (mid-morning and mid afternoon snack). | Dietary supplement | Experimental snack |
| Control SnackThe control snack will be consumed by 42 participants for 12-weeks. Snacks will be consumed twice a day (mid-morning and mid afternoon snack). | Dietary supplement | Control snack |
Primary outcome
Symptoms of depression and anxiety
Time frame: Week 0 and 12
Symptoms of depression and anxiety as measured by the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS). This is a 15-item self-report likert scale comprising the PHQ-8 and GAD-7. Scores can range from 0 to 48, cut points of 10,20 and 30 indicate mild, moderate and severe levels of depression/anxiety respectively.
24 secondary outcomes
Functional impairment
Time frame: Weeks 0,6 and 12
Sleep quality
Time frame: Weeks 0,6 and 12
Wellbeing
Time frame: Weeks 0,6 and 12
Quality of life
Time frame: Weeks 0,6 and 12
Physical activity
Time frame: Weeks 0,6 and 12
Symptoms of depression
Time frame: Weeks 0,6 and 12
Symptoms of anxiety
Time frame: Weeks 0,6 and 12
Psychological Distress
Time frame: Weeks 0,6 and 12
Faecal gut microbiota (composition, alpha- and beta-diversity)
Time frame: Week 0 and 12
Faecal short-chain fatty acids (SCFA)
Time frame: Week 0 and 12
Faecal water
Time frame: Week 0 and 12
Gut symptoms
Time frame: Week 0 and 12
Stool frequency
Time frame: Week 0 and 12
Stool consistency
Time frame: Week 0 and 12
Serum Vitamin E levels
Time frame: Week 0 and 12
Dietary intake
Time frame: Week 0 and 12
Acceptability of snack products
Time frame: Week 12
Snack compliance
Time frame: Week 12
Adverse events
Time frame: Week 0 to 12
Symptoms of depression and anxiety
Time frame: Week 0,6 and 12
Change in symptoms of depression and anxiety
Time frame: Week 0, 6 and 12
Proportion of people with no, mild, moderate and severe symptoms of anxiety and depression
Time frame: Week 0, 6 and 12
Proportion of people with no, mild, moderate and severe symptoms of depression
Time frame: Week 0, 6 and 12
Proportion of people with no, mild, moderate and severe symptoms of anxiety
Time frame: Week 0, 6 and 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
- Derived from this study: PubMed 42463057Sartori L, Argomaniz N, Farsi DN, Bajka B, Chrysostomou D, Marchesi JR, Chilcot J, Whelan K, Dimidi E. Almonds and Their Impact on Mental Health and the Gut-Brain Axis in Adults with Symptoms of Anxiety and Depression: A 12-Week Randomized Controlled Trial. J Nutr. 2026 Jul 16;156(9):101732. doi: 10.1016/j.tjnut.2026.101732. Online ahead of print.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention snack in people with Depression and Anxiety, run by King's College London 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 8 inclusion and 12 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: finished, as of the sponsor's last update on 18 Feb 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Symptoms of depression and anxiety (time frame: Week 0 and 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06087471, which also lists 1 linked publication.
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 18 Feb 2025.