HealthyCMNCT05260346
Modulation of the Gut-brain Axis by Cranberries: Impact on University Students' Mental Wellbeing
A study testing Cranberry juice in people with Healthy, run by King's College London at 1 site in United Kingdom.
Trial summary
In this work, the investigators will assess whether cranberry (poly)phenols improve mood disorders including stress, anxiety and depression via the gut-brain axis in university students. Read more about this study
- Who is it for?
- Ages 20 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Cranberry juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Jan 2022to 22 Aug 2022
- 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 20 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men and women aged 20-25 years old.
- Final year BSc or MSc university students.
- Subjects are willing to maintain their normal eating/drinking habits and exercise habits to avoid changes in body weight over the duration of the study.
- Able to understand the nature of the study.
- Able and willing to give signed written informed consent.
- Comply with all study protocol procedures.
Who cannot join
- Subjects taking regular prescribed medication (including iron for anemia).
- Grade 1 hypertensive or above, as defined as SBP superior or equal to 140 mmHg or DBP superior or equal to 90 mmHg.
- Obese participants, defined as BMI superior or equal to 30.
- Diabetes mellitus and metabolic syndrome.
- Chronic and acute disease.
- Terminal renal failure and other kidney abnormalities.
Show all 18Show fewer
- Malignancies.
- Allergies to berries or other significant food allergy.
- Subjects who took food supplements, dietary supplement or herbal remedies within 1 month of study start.
- Subjects who have lost more than 10% of their weight in the past 6 months or are currently in a diet.
- Subjects with allergies to berries or other relevant/related food.
- Subjects who reported participant in another study within one month before the study start.
- Subjects who smoke an irregular number of cigarettes per day or plan quitting smoking in the next 3 months.
- Subjects who require chronic antimicrobial or antiviral treatment
- Subjects with unstable psychological condition (diagnosed with mental health disorders).
- Subjects with history of cancer, myocardial infarction, cerebrovascular incident
- Pregnant, lactating or planning to become pregnant, as well as pre-menopausal women who do not have a regular menstrual cycle and do not adequate method of contraception.
- Any reason or condition that in the judgement of the clinical investigator(s) may put the subject at unacceptable risk or that may preclude the subject from understanding or complying with the study's requirements.
Trial locations and contacts
1 site in 1 country.
About this study
In this work, the investigators will assess whether cranberry (poly)phenols improve mood disorders including stress, anxiety and depression via the gut-brain axis in university students. The investigators will evaluate whether the effects observed are related to an improvement in gut microbiome diversity and function, and whether the mechanism of action may be mediated by a decrease in inflammatory markers, modulation of neurotransmitters or via an alteration of BDNF levels. The investigators will also quantify the most comprehensive panel of cranberry (poly)phenol metabolites. A double-blind, randomized placebo controlled 2-arm parallel study will be conducted in the Metabolic Research Unit (MRU, Department of Nutritional Sciences at KCL).
Read the detailed description
The study population will be final year BSc and MSc university students between 20-25 years old (n=60), who are generally healthy and not taking any medication. The study will be conducted during the period prior to their final exams (January until September). The intervention will be cranberry and placebo juice, consumed daily for 12 weeks, and will be provided free of cost by the Cranberry Institute. After a screening visit to evaluate inclusion and exclusion criteria, informed consent will be obtained, and subjects will be randomized to the treatments.
The study will consist in a total of 4 visits, one visit every 4 weeks over a total of 12 weeks intervention. Volunteers will consume a cranberry or a control drink every day for 12 weeks. The day before each visit (pre-visit), volunteers will self-collect a total of 6 saliva samples throughout the day to measure cortisol levels as a biomarker of stress. Mental health, cognitive function, diet and physical activity will also be assessed using self-reported questionnaires, an online cognitive battery test and an online 24 h dietary recall. In addition, on the day before visits 1 and 4 (baseline and 12 weeks), a stool sample will be self-collected to assess changes in gut microbiome diversity and composition. On the day of each visit, a spot urine sample will be self-collected after waking up and before breakfast. During each visit, volunteers will drop the self-collected samples, and will collect new kits for the next visit. Visits 1 and 4 will last approximately 20 min, while visits 2 and 3 will last approximately 5 minutes. In addition, during visits 1 and 4, blood samples will be taken to investigate changes in gut-brain axis and cranberry related metabolites. Blood samples will also be collected at baseline to assess general health status of participants (blood lipids, markers of liver and kidney function, urea, uric acid, creatinine, and glucose).
- Conditions
- Healthy
- Being tested
- Cranberry juice, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cranberry juiceDietary supplement
composition: Water, cranberry juice concentrate
PlaceboDietary supplement
composition: Water, dextrose, citric acid, malic acid, fumaric acid, colorants, xanthan gum, natural flavor, emulsion
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Cranberry flavored drink, once daily, in a 8fl oz bottle. Identical in appearance and taste compared with the treatment. Receives: Dietary Supplement: Placebo |
| Cranberry juice | Active comparator | 100% cranberry juice, once daily, in a 8fl oz bottle. Receives: Dietary Supplement: Cranberry juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in mood
Mood measured as the Total Mood Disturbance (TMD), using the Profile of Mood States (POMS) questionnaire. The POMS assessment has six scales of measure: Anger-Hostility, Confusion-Bewilderment, Depression-Dejection, Fatigue-Inertia, Tension-Anxiety, and Vigor-Activity. Scores on these items are added together to determine a Total Mood Disturbance score. Additionally, there is a measure of Friendliness which is scored separately. The POMS2 is an adjective checklist with instructions to respond "How have you been feeling over the PAST WEEK, INCLUDING TODAY" on a 5- point Likert response scale ranging from 0 = Not at all to 4 = Extremely. If one changes the instructions to "how you feel RIGHT NOW" then the instrument measures emotional states. This it is adaptable to both state and trait forms of affect. Higher scores mean a worse outcome.
Measured: Baseline and 12 weeks
Secondary outcomes (11)
Mental Health outcomes: stress levels
Mental Health outcomes including changes in stress levels, measured as salivary and blood cortisol and the Perceived Stress Scale (PSS) questionnaire. The questions in the PSS ask about feelings and thoughts during the last month. In each case, respondents are asked how often they felt a certain way. It consists of 10 questions, takes 5-10 minutes to complete and is for individual or group administration. Higher scores indicate higher levels of perceived stress.
Measured: Baseline and 12 weeks
Mental Health outcomes: anxiety
Mental Health outcomes including changes in anxiety and depression symptoms, measured with the Hospital Anxiety and Depression Scale (HADS) questionnaire. The questionnaire comprises seven questions for anxiety and seven questions for depression, and takes 2-5min to complete. For both scales (anxiety and depression), higher scores mean a worse outcome.
Measured: Baseline and 12 weeks
Changes in cognitive function and performance
Measured using the Online General Cognitive Assessment Battery (CogniFit) using established procedures. The cognitive score is an aggregate measure of the current cognitive strength of different cognitive skills. The minimum cognitive score is 0 and the maximum is 800. A higher score means higher cognitive abilities.
Measured: Baseline and 12 weeks
Changes in plasma gut-brain-axis metabolites
Serotonin and kynurenine pathway will be measured using targeted metabolomics
Measured: Baseline and 12 weeks
Changes in brain-derived neurotrophic factor
Brain-derived neurotrophic factor (BDNF) will be measured using established procedures
Measured: Baseline and 12 weeks
Changes in inflammatory markers
Inflammatory markers, including blood cytokines (IL1β, IL2, IL4, IL6, IL8, IL10, IL12, IL13, MIF, IFN-γ, and TNF-α), will be measured using established procedures
Measured: Baseline and 12 weeks
Changes in plasma and faecal short chain fatty acids
Measured using gas chromatography according to established procedures
Measured: Baseline and 12 weeks
Changes in plasma and urinary cranberry polyphenol metabolites
Measured using a validated targeted metabolomics method
Measured: Baseline and 12 weeks
Assessment of habitual diet
Diet will be assessed using 7-day food diaries (from the European Prospective Investigation into Cancer and Nutrition) at baseline and after 12 weeks.
Measured: Baseline and 12 weeks
Assessment of physical activity
The international physical activity questionnaire (IPAQ) will also be used to assess physical activity. IPAQ assesses physical activity undertaken across a comprehensive set of domains including leisure time, domestic and gardening (yard) activities, work-related and transport-related activity. The higher the score, the higher the physical activity level.
Measured: Baseline and 12 weeks
Changes in gut microbiome diversity and composition.
Faecal samples will be collected at baseline and 12 weeks after consumption of cranberry or placebo drinks. Gut microbiome diversity and composition will be analysed using 16s mRNA sequencing at the Genome Centre of Queen Mary University (London, UK).
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start10 Jan 2022
- Primary completion22 Aug 2022
- Study completion22 Aug 2022
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 HealthyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- The Cranberry Institute
- Responsible party
- Sponsor
- Investigators
- Ana Rodriguez-Mateos, PhD, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05260346
- Sponsor's protocol ID
- CRANMOOD study
- Acronym
- CM
- Status last verified
- Feb 2022
- First submitted
- 13 Jan 2022
- Last updated
- 22 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kamarunzaman NNZ, Le Sayec M, Li Y, Cheok A, Wu H, Zhang Z, Xu Y, Mesnage R, Dalrymple K, Pariante CM, Borsini A, Vauzour D, Bajka B, Rodriguez-Mateos A. Effects of (poly)phenol-rich cranberry on mental health in university students: The CRANMOOD randomised controlled trial. Clin Nutr. 2026 Jul;62:106677. doi: 10.1016/j.clnu.2026.106677. Epub 2026 Apr 28.
PubMed 42134099
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation of the Gut-brain Axis by Cranberries: Impact on University Students' Mental Wellbeing
- ClinicalTrials.gov ID
- NCT05260346
- Acronym / sponsor ID
- CM / CRANMOOD study
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- The Cranberry Institute
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 22 Aug 2022 (actual)
- Study completion
- 22 Aug 2022 (actual)
- First posted
- 2 Mar 2022 (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.
In this work, the investigators will assess whether cranberry (poly)phenols improve mood disorders including stress, anxiety and depression via the gut-brain axis in university students. The investigators will evaluate whether the effects observed are related to an improvement in gut microbiome diversity and function, and whether the mechanism of action may be mediated by a decrease in inflammatory markers, modulation of neurotransmitters or via an alteration of BDNF levels. The investigators will also quantify the most comprehensive panel of cranberry (poly)phenol metabolites. A double-blind, randomized placebo controlled 2-arm parallel study will be conducted in the Metabolic Research Unit (MRU, Department of Nutritional Sciences at KCL).
Detailed description
The study population will be final year BSc and MSc university students between 20-25 years old (n=60), who are generally healthy and not taking any medication. The study will be conducted during the period prior to their final exams (January until September). The intervention will be cranberry and placebo juice, consumed daily for 12 weeks, and will be provided free of cost by the Cranberry Institute. After a screening visit to evaluate inclusion and exclusion criteria, informed consent will be obtained, and subjects will be randomized to the treatments.
The study will consist in a total of 4 visits, one visit every 4 weeks over a total of 12 weeks intervention. Volunteers will consume a cranberry or a control drink every day for 12 weeks. The day before each visit (pre-visit), volunteers will self-collect a total of 6 saliva samples throughout the day to measure cortisol levels as a biomarker of stress. Mental health, cognitive function, diet and physical activity will also be assessed using self-reported questionnaires, an online cognitive battery test and an online 24 h dietary recall. In addition, on the day before visits 1 and 4 (baseline and 12 weeks), a stool sample will be self-collected to assess changes in gut microbiome diversity and composition. On the day of each visit, a spot urine sample will be self-collected after waking up and before breakfast. During each visit, volunteers will drop the self-collected samples, and will collect new kits for the next visit. Visits 1 and 4 will last approximately 20 min, while visits 2 and 3 will last approximately 5 minutes. In addition, during visits 1 and 4, blood samples will be taken to investigate changes in gut-brain axis and cranberry related metabolites. Blood samples will also be collected at baseline to assess general health status of participants (blood lipids, markers of liver and kidney function, urea, uric acid, creatinine, and glucose).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Parallel assignment
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboCranberry flavored drink, once daily, in a 8fl oz bottle. Identical in appearance and taste compared with the treatment. |
| Cranberry juice | Active comparator | Dietary Supplement: Cranberry juice100% cranberry juice, once daily, in a 8fl oz bottle. |
Who may qualify
- Ages
- 20 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy men and women aged 20-25 years old.
- Final year BSc or MSc university students.
- Subjects are willing to maintain their normal eating/drinking habits and exercise habits to avoid changes in body weight over the duration of the study.
- Able to understand the nature of the study.
- Able and willing to give signed written informed consent.
Key exclusion criteria (18 listed)
- Subjects taking regular prescribed medication (including iron for anemia).
- Grade 1 hypertensive or above, as defined as SBP superior or equal to 140 mmHg or DBP superior or equal to 90 mmHg.
- Obese participants, defined as BMI superior or equal to 30.
- Diabetes mellitus and metabolic syndrome.
- Chronic and acute disease.
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 |
|---|---|---|
| Cranberry juicecomposition: Water, cranberry juice concentrate | Dietary supplement | Cranberry juice |
| Placebocomposition: Water, dextrose, citric acid, malic acid, fumaric acid, colorants, xanthan gum, natural flavor, emulsion | Dietary supplement | Placebo |
Primary outcome
Changes in mood
Time frame: Baseline and 12 weeks
Mood measured as the Total Mood Disturbance (TMD), using the Profile of Mood States (POMS) questionnaire. The POMS assessment has six scales of measure: Anger-Hostility, Confusion-Bewilderment, Depression-Dejection, Fatigue-Inertia, Tension-Anxiety, and Vigor-Activity. Scores on these items are added together to determine a Total Mood Disturbance score. Additionally, there is a measure of Friendliness which is scored separately. The POMS2 is an adjective checklist with instructions to respond "How have you been feeling over the PAST WEEK, INCLUDING TODAY" on a 5- point Likert response scale ranging from 0 = Not at all to 4 = Extremely. If one changes the instructions to "how you feel RIGHT NOW" then the instrument measures emotional states. This it is adaptable to both state and trait forms of affect. Higher scores mean a worse outcome.
11 secondary outcomes
Mental Health outcomes: stress levels
Time frame: Baseline and 12 weeks
Mental Health outcomes: anxiety
Time frame: Baseline and 12 weeks
Changes in cognitive function and performance
Time frame: Baseline and 12 weeks
Changes in plasma gut-brain-axis metabolites
Time frame: Baseline and 12 weeks
Changes in brain-derived neurotrophic factor
Time frame: Baseline and 12 weeks
Changes in inflammatory markers
Time frame: Baseline and 12 weeks
Changes in plasma and faecal short chain fatty acids
Time frame: Baseline and 12 weeks
Changes in plasma and urinary cranberry polyphenol metabolites
Time frame: Baseline and 12 weeks
Assessment of habitual diet
Time frame: Baseline and 12 weeks
Assessment of physical activity
Time frame: Baseline and 12 weeks
Changes in gut microbiome diversity and composition.
Time frame: Baseline and 12 weeks
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 22 Nov 2022.
- Derived from this study: PubMed 42134099Kamarunzaman NNZ, Le Sayec M, Li Y, Cheok A, Wu H, Zhang Z, Xu Y, Mesnage R, Dalrymple K, Pariante CM, Borsini A, Vauzour D, Bajka B, Rodriguez-Mateos A. Effects of (poly)phenol-rich cranberry on mental health in university students: The CRANMOOD randomised controlled trial. Clin Nutr. 2026 Jul;62:106677. doi: 10.1016/j.clnu.2026.106677. Epub 2026 Apr 28.
- 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.
Ana Rodriguez-Mateos, PhD principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cranberry juice in people with Healthy, 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 6 inclusion and 18 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 22 Nov 2022. 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?
Changes in mood (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?
On the ClinicalTrials.gov record for NCT05260346, 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 22 Nov 2022.