Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06546020
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-01
Brief Title:
Gut Microbiota-dependent Health Impacts of Haskap Berries
Sponsor:
None
Organization:
None
Study Overview
Official Title:
PARTNERSHIP Elucidating Gut Microbiota-dependent Health Impacts of Haskap Berries to Inform Agricultural Production Practices That Will Maximize Bioactive Potential
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HIH
Brief Summary:
Polyphenol-rich Haskap berries Haskap have untapped therapeutic potential to improve human health and agricultural producers in northern US states are poised to increase production if consumer demand increases A critical knowledge gap is that little is known about the interactions between gut microbes and Haskap polyphenols to produce bioactive metabolites linked to downstream health impacts Additionally little is known about which Haskap varieties and harvest timing yield the greatest bioactive potential This study aims to address these gaps by investigating the interaction of bioactive components in Haskap with gut microbiota and the resultant gut and serum metabolites inflammation and metabolic health and then couple this with analysis of berries from different Haskap varieties and harvest times
Detailed Description:
The long-term goal of this project is to form a partnership linking the health impacts of Haskap varieties and management practices that maximize health-promoting compounds to benefit both consumers and producers Specific objectives of this study are to determine 1 the impact of Haskap on the gut microbiome and metabolome 2 how gut microbiome composition and production of bioactive metabolites from Haskap impacts health and inflammation biomarkers and 3 which Haskap varieties and growing practices increase production of health-promoting compounds
To accomplish this a four-armed randomized triple-blind placebo controlled clinical trial of Haskap versus placebo for two separate groups with distinctly low and high metabolic syndrome status will be completed Participants will be assessed for health biometrics gut microbiome composition inflammation and both the gut and serum metabolome before and after 8 weeks of intervention Haskap fruit from twenty varieties will primarily come from the randomized block design field trial and fruit will be harvested at four stages of fruit maturity then analyzed for polyphenol content This part of the study will be replicated over three growing seasons
To accomplish this a four-armed randomized triple-blind placebo controlled clinical trial of Haskap versus placebo for two separate groups with distinctly low and high metabolic syndrome status will be completed Participants will be assessed for health biometrics gut microbiome composition inflammation and both the gut and serum metabolome before and after 8 weeks of intervention Haskap fruit from twenty varieties will primarily come from the randomized block design field trial and fruit will be harvested at four stages of fruit maturity then analyzed for polyphenol content This part of the study will be replicated over three growing seasons
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None