Modulation of the Gut-brain Axis by Cranberries: Impact on University Students' Mental Wellbeing

NCT05260346 | Completed

• 1 other identifier: CRANMOOD study
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 12 weeks

Secondary Outcomes (11)

• Mental Health outcomes: stress levels

  Baseline and 12 weeks

• Mental Health outcomes: anxiety

  Baseline and 12 weeks

• Changes in cognitive function and performance

  Baseline and 12 weeks

• Changes in plasma gut-brain-axis metabolites

  Baseline and 12 weeks

• Changes in brain-derived neurotrophic factor

  Baseline and 12 weeks

Other Outcomes (6)

• Changes in plasma metabolome

  Baseline and 12 weeks

• Changes in urinary metabolome

  Baseline and 12 weeks

• Changes in gene expression

  Baseline and 12 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Cranberry flavored drink, once daily, in a 8fl oz bottle. Identical in appearance and taste compared with the treatment.

Dietary Supplement: Placebo

Cranberry juice

ACTIVE COMPARATOR

100% cranberry juice, once daily, in a 8fl oz bottle.

Dietary Supplement: Cranberry juice

Interventions

Cranberry juice DIETARY_SUPPLEMENT

composition: Water, cranberry juice concentrate

Cranberry juice

Placebo DIETARY_SUPPLEMENT

composition: Water, dextrose, citric acid, malic acid, fumaric acid, colorants, xanthan gum, natural flavor, emulsion

Placebo

Eligibility Criteria

• Age: 20 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• King's College London: lead
• The Cranberry Institute: collaborator

Study Sites (1)

King's College London

London, England, SE1 9NH, United Kingdom

Location

Study Officials

• Ana Rodriguez-Mateos, PhD

  King's College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double (Participant, Investigator)
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel assignment

Study Record Dates

• First Submitted: January 13, 2022
• First Posted: March 2, 2022
• Study Start: January 10, 2022
• Primary Completion: August 22, 2022
• Study Completion: August 22, 2022
• Last Updated: November 22, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)