Effects of Haskap Berries on Gut Health and Metabolism
PARTNERSHIP: Elucidating Gut Microbiota-dependent Health Impacts of Haskap Berries to Inform Agricultural Production Practices That Will Maximize Bioactive Potential
This study tests whether drinking smoothies made with Haskap berries can improve gut health and metabolism in people over eight weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 35 Years to 65 Years |
| Sex | All |
| Sponsor | Montana State University Academic / other |
| Locations | 1 site (Bozeman, Montana) |
| Trial ID | NCT06546020 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals with either healthy or unhealthy metabolic profiles based on specific waist circumference and blood biomarker criteria.
Not a fit: Patients with diabetes, significant obesity, or those on medications that affect metabolism may not benefit from this study.
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 performed: While the specific interaction of Haskap berries with gut microbiota is novel, similar studies on polyphenol-rich foods have shown promising health benefits.
Eligibility criteria
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 this trial is running
Bozeman, Montana
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.