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NCT05596500
Blueberry-protein Supplementation and Exercise
Conditions: Inflammatory Response
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 20
Sponsor: Appalachian State University
Location: Turkey
Summary
This study is the human clinical trial component of an SBIR grant with Sinnovatek (funded).
Cyclists (n=20) will consume a blueberry-protein, blueberry, or placebo supplement for 2 weeks prior to cycling for 2.5 h at high intensity.
Washout periods (2 weeks) will separate the 3 trials, and the cyclists will crossover (randomized) to one of the two others supplements for 2 weeks, and then engage in additional 2.5 h cycling bouts.
Blood and urine samples will be collected pre- and post-supplementation for each of the 3 trials.
Blood samples will also be collected immediately after and 1.5h- and 24h-post-exercise.
Blood samples will be analyzed for inflammation and oxidative stress outcomes.
Urine samples will be analyzed for blueberry gut-derived phenolics.
Eligibility Criteria
Inclusion Criteria:Male or female.Ages 18-65 years.Non-smoker.Regularly compete in road races (category 1 to 5) and/or are capable of cycling 2.5 h in a laboratory setting (using their own bicycles on Saris training systems).Agree to train normally, maintain weight, and avoid the regular use of large-dose vitamin and mineral supplements, herbs, and medications that influence inflammation and immune function (especially Advil, Motrin, aspirin, and similar anti-inflammatory drugs) for the duration of the 6-week study.
(Review supplement and medication use with the Research Manager during orientation).Categorized as "low risk" using the American College of Sports Medicine screening questionnaire.Generally healthy and without chronic disease including cardiovascular disease (e.g., heart disease, stroke), cancer, type 1 and 2 diabetes, rheumatoid arthritis.Exclusion Criteria:Inability to comply with study requirements.Body weight below 100 pounds.Pregnant or breastfeeding.Any other concurrent condition which, in the opinion of the primary investigator (PI), would preclude participation in this study or interfere with compliance.Current diagnosis of cardiovascular disease, diabetes, or cancer (except for non-melanoma skin cancer).History of allergic reactions to blueberries.
Source: ClinicalTrials.gov (NCT05596500). StuddyBuddy aggregates publicly available trial information.