RecruitingNot ApplicableNCT06546020

Gut Microbiota-dependent Health Impacts of Haskap Berries

PARTNERSHIP: Elucidating Gut Microbiota-dependent Health Impacts of Haskap Berries to Inform Agricultural Production Practices That Will Maximize Bioactive Potential


Sponsor

Montana State University

Enrollment

120 participants

Start Date

Feb 26, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 35 YearsMax Age: 65 Years

Inclusion Criteria15

  • All of the following:
  • Waist circumference: men ≤ 40, women ≤ 35 inches
  • Systolic blood pressure: ≤ 130 mmHg
  • Diastolic blood pressure: ≤ 85 mmHg
  • Fasting glucose: ≤ 100 mg·dl-1
  • Fasting triglycerides: ≤ 150 mg·dl-1
  • HDL: men > 40, women > 50 mg·dl-1
  • Required:
  • \- Waist circumference: men ≥ 40, women ≥ 35 inches
  • AND ≥ 1 of the following:
  • Systolic blood pressure: > 130 mmHg
  • Diastolic blood pressure: > 85 mmHg
  • Fasting glucose: > 100 mg·dl-1
  • Fasting triglycerides: > 150 mg·dl-1
  • HDL: men ≤ 40, women ≤ 50 mg·dl-1

Exclusion Criteria12

  • BMI <18 or > 40 kg/m\^2
  • potential allergy to Haskap or placebo ingredients
  • use of anti-inflammatory, lipid lowering, glucose lowering, blood pressure, or any other medications that may interfere with study measures
  • pregnant or lactating woman
  • diagnosis with type 1 or type 2 diabetes or any other condition that may interfere with study measures
  • smoke cigarettes
  • have taken antibiotics in the past 90 days
  • take supplements including pre/probiotics or "superfoods" within 30 days of starting the study
  • are planning on starting a weight loss or exercise regiment change
  • follow a specific diet such as low carbohydrate, vegan, and vegetarian
  • consume over 5 servings of fruit/vegetables per day
  • are unwilling to reduce caffeine intake to one 8 oz serving per day for the durations of the study

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Interventions

DIETARY_SUPPLEMENTHaskap berry smoothie

A smoothie blend of berries and water

DIETARY_SUPPLEMENTPlacebo comparator

A smoothie with no polyphenolic content and matched in carbohydrate composition to the experimental haskap smoothie


Locations(1)

Montana State University

Bozeman, Montana, United States

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NCT06546020


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