Clinical trial Recruiting at 1 site Interventional Ages 35 to 65

Effects of Haskap Berries on Gut Health and Metabolism

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

Run by Montana State University · NCT06546020 · Data updated 2026-11-12

This study tests whether drinking smoothies made with Haskap berries can improve gut health and metabolism in people over eight weeks.

More Metabolic Disease trials

Quick facts

Study typeInterventional
Ages35 Years to 65 Years
SexAll
Enrollment120 (estimated)
SponsorMontana State University
Academic / other
Locations1 site (Bozeman, Montana)
StatusRecruiting
StartedFebruary 26, 2025
Main results expectedMay 2027
Study endsMay 2028
Registry record updatedApril 2, 2025
Trial IDNCT06546020 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include individuals with either healthy or unhealthy metabolic profiles based on specific waist circumference and blood biomarker criteria.

Probably not a fit

Patients with diabetes, significant obesity, or those on medications that affect metabolism may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the health impacts of polyphenol-rich Haskap berries on gut microbiota and metabolic health. It involves a randomized, triple-blind, placebo-controlled trial comparing Haskap berry smoothies to a placebo over eight weeks. Participants will be categorized into metabolically healthy and unhealthy groups, and their health metrics, gut microbiome composition, and serum metabolites will be assessed before and after the intervention. The study also aims to identify which Haskap varieties and harvest timings yield the most beneficial health effects.

Why it matters

Potential benefit: If successful, this study could provide insights into how Haskap berries can improve gut health and metabolic conditions.

How similar studies have gone: While the specific interaction of Haskap berries with gut microbiota is novel, similar studies on polyphenol-rich foods have shown promising health benefits.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • Montana State University
    Bozeman, Montana, United States
    Recruiting

Study contacts

  • Principal investigator: Mary P Miles, PhD — Montana State University
  • Study coordinator: Mary P Miles, PhD
  • Email: mmiles@montana.edu
  • Phone: 406-994-6678

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.