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Search / Trial NCT06546020

Gut Microbiota-dependent Health Impacts of Haskap Berries

Launched by MONTANA STATE UNIVERSITY · Aug 5, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Microbial Metabolism Gut Microbial Composition Serum Metabolome Polyphenols

ClinConnect Summary

This clinical trial is exploring the health benefits of Haskap berries, which are rich in natural compounds called polyphenols. Researchers want to understand how these berries interact with the good bacteria in our guts and how they may help improve conditions related to metabolic health and inflammation. The study will look at different types of Haskap berries and the best times to harvest them to see which have the most health benefits.

If you are interested in participating, you may qualify if you are between the ages of 12 and 74 and meet certain health criteria. For example, if you are metabolically healthy, you should have a normal waist size and blood pressure, while those who are metabolically unhealthy will have larger waist sizes and may have high blood pressure or blood sugar levels. Participants can expect to consume Haskap berries or a placebo (a non-active version) and will be monitored for changes in their health throughout the study. Please note that there are specific requirements and restrictions for participation, so it’s important to review those carefully before considering joining the trial.

Gender

ALL

Eligibility 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

About Montana State University

Montana State University (MSU) is a leading research institution committed to advancing health and science through innovative clinical trials. With a strong emphasis on interdisciplinary collaboration, MSU leverages its robust academic resources and expertise to conduct cutting-edge research that addresses critical health challenges. The university's Clinical Trials Unit is dedicated to ensuring the highest standards of scientific integrity and participant safety, facilitating a diverse range of studies that contribute to the advancement of medical knowledge and the improvement of patient outcomes. Through its commitment to excellence, MSU aims to foster impactful research that benefits both local communities and the broader global population.

Locations

Bozeman, Montana, United States

Patients applied

0 patients applied

Trial Officials

Mary P Miles, PhD

Principal Investigator

Montana State University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported