Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2026-01-03 @ 9:28 PM
Study NCT ID:
NCT06546020
Status:
RECRUITING
Last Update Posted:
2025-04-02
First Post:
2024-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gut Microbiota-dependent Health Impacts of Haskap Berries
Sponsor:
Montana State University
Organization:
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:
RECRUITING
Status Verified Date:
2025-04
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:
HIH
Brief Summary:
Polyphenol-rich Haskap berries (Haskap) have untapped therapeutic potential to improve human health, and agricultural producers in northern U.S. 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, fat oxidation, 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, fat oxidation, 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:
False
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?:
None
Is an FDA AA801 Violation?: