Actively Recruiting

Phase Not Applicable
Age: 35Years - 65Years
All Genders
Healthy Volunteers
NCT06546020

Gut Microbiota-dependent Health Impacts of Haskap Berries

Led by Montana State University · Updated on 2025-04-02

120

Participants Needed

1

Research Sites

165 weeks

Total Duration

On this page

Sponsors

M

Montana State University

Lead Sponsor

M

Montana State Agricultural Experiment Station

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Gut Microbiota-dependent Health Impacts of Haskap Berries

Who Can Participate

Age: 35Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 35 to 65 years
  • For metabolically healthy group: waist circumference men 4, women 35 inches or less
  • For metabolically healthy group: systolic blood pressure 30 mmHg or less
  • For metabolically healthy group: diastolic blood pressure 5 mmHg or less
  • For metabolically healthy group: fasting glucose 00 mg/dL or less
  • For metabolically healthy group: fasting triglycerides 50 mg/dL or less
  • For metabolically healthy group: HDL cholesterol men greater than 40 mg/dL, women greater than 50 mg/dL
  • For metabolically unhealthy group: waist circumference men 40 inches or more, women 35 inches or more
  • For metabolically unhealthy group: at least one of the following: systolic blood pressure greater than 130 mmHg, diastolic blood pressure greater than 85 mmHg, fasting glucose greater than 100 mg/dL, fasting triglycerides greater than 150 mg/dL, or HDL cholesterol men 40 mg/dL or less, women 50 mg/dL or less
Not Eligible

You will not qualify if you...

  • Body mass index less than 18 or greater than 40 kg/m2
  • Allergy to Haskap or placebo ingredients
  • Use of anti-inflammatory, lipid lowering, glucose lowering, blood pressure, or other medications that may affect study measures
  • Pregnant or lactating women
  • Diagnosis of type 1 or type 2 diabetes or any condition interfering with study measures
  • Current cigarette smoker
  • Antibiotic use within the past 90 days
  • Use of supplements including prebiotics, probiotics, or "superfoods" within 30 days before study start
  • Planning to start a weight loss or exercise regimen change
  • Following a specific diet such as low carbohydrate, vegan, or vegetarian
  • Consuming more than 5 servings of fruits or vegetables per day
  • Unwillingness to reduce caffeine intake to one 8 oz serving per day during the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Montana State University

Bozeman, Montana, United States, 59717

Actively Recruiting

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Research Team

M

Mary P Miles, PhD

CONTACT

Z

Zachary T Miller, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

4

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Gut Microbiota-dependent Health Impacts of Haskap Berries | DecenTrialz