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Gut Microbiota-dependent Health Impacts of Haskap Berries

Montana State University · with Montana State Agricultural Experiment Station · NCT06546020

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 35–65 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
120
US sites recruiting
1
Study start
February 26, 2025
Record last updated
April 2, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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.

Being studied: Haskap berry smoothie; Placebo comparator

Conditions: Metabolic Disease; Inflammation; Microbial Colonization

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria for Metabolically Healthy Group:

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

Inclusion Criteria for Metabolically Unhealthy Group:

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 Criteria

  • 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

Recruiting US locations

  • Montana State University

    Bozeman, MT 59717

    Site contact: Mary P Miles, PhD · 406-994-6678 · mmiles@montana.edu

Study contacts (from the official record)

  • Mary P Miles, PhD · 406-994-6678 · mmiles@montana.edu
  • Zachary T Miller, PhD · (406) 961-3025 · zachariah.miller@montana.edu
All nutrition & metabolism studies in Montana →
Gut Microbiota-dependent Health Impacts of Haskap Berries (NCT06546020) | Bored Studies