APC Microbiome Ireland
Cork, T12YT20, Ireland
Location status: Recruiting
Location contact
Gerard Clarke, PhD
SUB_INVESTIGATOR
John F Cryan, PhD
PRINCIPAL_INVESTIGATOR
Revathy Munuswamy, PhD
CONTACT
(+353) 021 4901721
NCT Number: NCT05931562
This study aims to investigate the effects of an 8-week dietary intervention on cognitive function, stress, and the gut microbiota in healthy adults with low fibre intake.
Interested in participating?
Request Info18 year–50 year
All sexes
Interventional
Not applicable
Cork, T12YT20, Ireland
Location status: Recruiting
Gerard Clarke, PhD
SUB_INVESTIGATOR
John F Cryan, PhD
PRINCIPAL_INVESTIGATOR
Revathy Munuswamy, PhD
CONTACT
(+353) 021 4901721
The gut microbiota communicates bidirectionally with the brain via the microbiota-gut-brain axis to influence various aspects of human physiology, including host metabolism, immune function, behaviour, and cognition. Diet is a key modulator of the microbial composition, suggesting that the microbiota could explain the association between poor nutrition and decreasing health of the population. Dietary fibre is the main energy source for the gut microbiota and fundamentally impacts its composition and function. The microbiota-gut-brain axis has been proposed to mediate some of the effects of dietary fibre on the brain, for example through microbial metabolites (e.g., short-chain fatty acids (SCFA)), regulation of the immune system, and the microbial impact on gut hormones and neurotransmitters. Similarly, intake of fermented foods is positively associated with cognitive health and has been shown to alter the microbiota composition and function and exert an anti-inflammatory effect. However, no studies to date have examined the singular and combined effects of fermented and fibrous foods on the gut microbiota, cognition, and emotion. The present study aims to determine the role of diet on the microbiota-gut-brain axis and mental health.
Using a randomized-controlled, parallel, single-blinded design, participants consuming a habitually low fibre diet (N=200) will undergo an 8-week dietary intervention. Participants will receive one of four diets (n=50 in each group): high fibre (aim 24-35 grams/day), fermented foods (aim 4-6 portions/day), combined diet of fermented foods and high fibre (aim 25-30g/day of fibre and 3-4 servings/day of fermented foods) or control (dietary education according to national Irish guidelines). Cognitive, psychological, and biological measures will be compared at baseline and endpoint. During the intervention period, individuals will provide repeated faecal samples to assess temporal microbial changes.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will recieve dietary education to include 4 to 6 portions of fermented foods to their normal diet.
Participants will recieve dietary education to increase their fibre intake to 24-35g/day in their normal diet.
Participants will recieve dietary education to increase their fibre intake to 25-30g/day and include 3 to 4 portions of fermented foods to their normal diet.
Participants will recieve dietary education based on the Irish healthy food pyramid.
Time frame: Change from baseline at 8 weeks
self-report questionnaires
Time frame: Change from baseline at 8 weeks
Cortisol from saliva samples
Time frame: Change from baseline at 8 weeks
Self-report questionnaires
Time frame: Change from baseline at 8 weeks
Galvanic skin response taken from the skin on the hand
Time frame: Change from baseline at 8 weeks
Cortisol from saliva samples
Time frame: Change from baseline at 8 weeks
Spatial Working Memory
Time frame: Change from baseline at 8 weeks
Modified Rey Auditory Verbal Learning Test (ModRey)
Time frame: Change from baseline at 8 weeks
Iowa Gambling Task
Time frame: Change from baseline at 8 weeks
Emotional Stroop
Time frame: Change from baseline at 8 weeks
Rapid Visual Information Processing
Time frame: Change from baseline at 8 weeks
Pattern Recognition Memory
Time frame: Change from baseline at 8 weeks
Intra-Extra Dimensional Set Shifting
Time frame: Change from baseline at 8 weeks
Emotion Recognition Task
Time frame: Change from baseline at 8 weeks
Emotional Bias Task
Time frame: Change from baseline at 8 weeks
Shotgun metagenomics of fecal samples
Time frame: Change from baseline at 8 weeks
Untargeted metabolomics analysis
Time frame: Change from baseline at 8 weeks
Inflammatory markers in lipopolysaccharide stimulated and unstimulated bloods
Contact information is provided by the study sponsor or research team.
Elizabeth Schneider, PhD
CONTACT
(+353) 021 4901721
Revathy Munuswamy
CONTACT
University College Cork
Other
An Interventional Study on the Association Between Diet, Cognitive Function, Stress and the Gut Microbiota in Healthy Volunteers.
Acronym: NMB
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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