Ignite Creation Date:
2024-05-06 @ 5:18 PM
Last Modification Date:
2024-10-26 @ 2:26 PM
Study NCT ID:
NCT05260346
Status:
COMPLETED
Last Update Posted:
2022-11-22
First Post:
2022-01-13
Brief Title:
Modulation of the Gut-brain Axis by Cranberries Impact on University Students Mental Wellbeing
Sponsor:
Kings College London
Organization:
Kings College London
Study Overview
Official Title:
Modulation of the Gut-brain Axis by Cranberries Impact on University Students Mental Wellbeing
Status:
COMPLETED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CM
Brief Summary:
In this work the investigators will assess whether cranberry polyphenols 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 polyphenol 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 n60 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None