NCT06546020 Gut Microbiota-dependent Health Impacts of Haskap Berries
| NCT ID | NCT06546020 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Montana State University |
| Condition | Metabolic Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-02-26 |
| Primary Completion | 2027-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2025-02-26 with a primary completion date of 2027-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Mary P Miles, PhD
PRINCIPAL INVESTIGATOR
Montana State University
Frequently Asked Questions
Who can join the NCT06546020 clinical trial?
This trial is open to participants of all sexes, aged 35 Years or older, up to 65 Years, studying Metabolic Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06546020 currently recruiting?
Yes, NCT06546020 is actively recruiting participants. Contact the research team at mmiles@montana.edu for enrollment information.
Where is the NCT06546020 trial being conducted?
This trial is being conducted at Bozeman, United States.
Who is sponsoring the NCT06546020 clinical trial?
NCT06546020 is sponsored by Montana State University. The principal investigator is Mary P Miles, PhD at Montana State University. The trial plans to enroll 120 participants.