Status:
RECRUITING
Gut Microbiota-dependent Health Impacts of Haskap Berries
Lead Sponsor:
Montana State University
Collaborating Sponsors:
Montana State Agricultural Experiment Station
Conditions:
Metabolic Disease
Inflammation
Eligibility:
All Genders
35-65 years
Phase:
NA
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 de...
Detailed Description
The long-term goal of this project is to form a partnership linking the health impacts of Haskap varieties and management practices that maximize health-promoting compounds to benefit both consumers a...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 26 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2028
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06546020
Start Date
February 26 2025
End Date
May 1 2028
Last Update
April 2 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Montana State University
Bozeman, Montana, United States, 59717