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Polyphenols
Haskap Berries for Gut Health (HIH Trial)
Bozeman, MT
N/A
Recruiting
Led By Mary P Miles, PhD
Research Sponsored by Montana State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
* Waist circumference: men ≤ 40, women ≤ 35 inches
* HDL: men \> 40, women \> 50 mg·dl-1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Summary
"This trial aims to study the potential health benefits of Haskap berries and how they interact with gut bacteria to produce beneficial substances. The study will also look at which types of Haskap berries and
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Who is the study for?
This trial is for individuals with specific health measurements: men must have a waist circumference ≤ 40 inches and women ≤ 35 inches, blood pressure ≤ 130/85 mmHg, fasting glucose ≤ 100 mg/dl, triglycerides ≤ 150 mg/dl, and HDL cholesterol >40 mg/dl for men and >50 mg/dl for women.Check my eligibility
What is being tested?
The study tests the health effects of Haskap berry smoothies on gut microbiota and inflammation compared to a placebo. It will also analyze how different varieties and harvest times of Haskap berries affect these outcomes.See study design
What are the potential side effects?
Since this trial involves consuming Haskap berry smoothies, potential side effects may include digestive discomfort or allergic reactions in those sensitive to berries or any ingredients in the smoothie.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My waist is 40 inches or less if I'm a man, 35 inches or less if I'm a woman.
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Select...
My HDL cholesterol is above 40 (if I'm a man) or 50 (if I'm a woman).
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Select...
My waist is at least 40 inches (if male) or 35 inches (if female).
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
16 subunit ribosomal ribonucleic acid (16S rRNA) gut microbial composition
Exercise Induced Fat Oxidation
F2 isoprostanes
+3 moreSecondary study objectives
Acute Diet
Anthropometric Assessments
Blood pressure
+2 moreTrial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Haskap, Metabolically UnhealthyExperimental Treatment1 Intervention
The haskap supplement will consist of a haskap berry smoothie. A twice daily dose (10-12) hours apart will be consumed for 8 weeks.
Group II: Haskap, Metabolically HealthyExperimental Treatment1 Intervention
The haskap supplement will consist of a haskap berry smoothie. A twice daily dose (10-12) hours apart will be consumed for 8 weeks.
Group III: Placebo, Metabolically UnhealthyPlacebo Group1 Intervention
The placebo supplement will have no polyphenol content and will be carbohydrate-matched to the experimental group. A twice daily dose (10-12 hours apart) will be consumed for 8 weeks.
Group IV: Placebo, Metabolically HealthyPlacebo Group1 Intervention
The placebo supplement will have no polyphenol content and will be carbohydrate-matched to the experimental group. A twice daily dose (10-12 hours apart) will be consumed for 8 weeks.
Find a Location
Closest Location:Montana State University· Bozeman, MT· 1468 miles
Who is running the clinical trial?
Montana State Agricultural Experiment StationUNKNOWN
Montana State UniversityLead Sponsor
45 Previous Clinical Trials
1,043,315 Total Patients Enrolled
Mary P Miles, PhDPrincipal InvestigatorMontana State University
6 Previous Clinical Trials
243 Total Patients Enrolled