Gut Microbiota-dependent Health Impacts of Haskap Berries

Part of paid clinical trials in Bozeman, Montana.

Sponsor
Montana State University
Study ID
NCT06546020
Status
Recruiting
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Conditions

  • Inflammation
  • Metabolic Disease
  • Microbial Colonization

Eligibility Criteria

Sex
ALL
Age
35 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Haskap berry smoothie — DIETARY_SUPPLEMENT
    A smoothie blend of berries and water
  • Placebo comparator — DIETARY_SUPPLEMENT
    A smoothie with no polyphenolic content and matched in carbohydrate composition to the experimental haskap smoothie

Study Details

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.

Key Dates

Start date
Feb 26, 2025
Status verified
Apr 2025
Primary completion
May 31, 2027
Completion
May 31, 2028

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Placebo Comparator: Placebo, Metabolically Healthy
    The placebo supplement will have no polyphenol content and will be carbohydrate-matched to the experimental group. A twice daily dose (10-12 hours apart) will be consumed for 8 weeks.
  • Experimental: Haskap, Metabolically Healthy
    The haskap supplement will consist of a haskap berry smoothie. A twice daily dose (10-12) hours apart will be consumed for 8 weeks.
  • Placebo Comparator: Placebo, Metabolically Unhealthy
    The placebo supplement will have no polyphenol content and will be carbohydrate-matched to the experimental group. A twice daily dose (10-12 hours apart) will be consumed for 8 weeks.
  • Experimental: Haskap, Metabolically Unhealthy
    The haskap supplement will consist of a haskap berry smoothie. A twice daily dose (10-12) hours apart will be consumed for 8 weeks.

Primary Outcome Measure

16 subunit ribosomal ribonucleic acid (16S rRNA) gut microbial composition [ Time Frame: 8 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Montana State UniversityBozemanMontana59717
Mary P Miles, PhD
[email protected]
406-994-6678
Brian Bothner, PhD
[email protected]
1-406-994-5270

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By research site
Montana State University· Bozeman, MT

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