Status:
COMPLETED
Modulation of the Gut-brain Axis by Cranberries: Impact on University Students' Mental Wellbeing
Lead Sponsor:
King's College London
Collaborating Sponsors:
The Cranberry Institute
Conditions:
Healthy
Eligibility:
All Genders
20-25 years
Phase:
NA
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 investiga...
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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).
- 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.
Key Trial Info
Start Date :
January 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 22 2022
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT05260346
Start Date
January 10 2022
End Date
August 22 2022
Last Update
November 22 2022
Active Locations (1)
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1
King's College London
London, England, United Kingdom, SE1 9NH