Status:
COMPLETED
Flavonoids, Exercise, Gut-Derived Phenolics
Lead Sponsor:
Appalachian State University
Collaborating Sponsors:
Reoxcyn Discoveries Group
Conditions:
Exercise and Gut-derived Phenolics
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
PURPOSE: 1. PRIMARY: Using a randomized, parallel group design, this investigation will determine if the combination of 2-weeks polyphenol supplementation (using the Reoxcyn flavonoid supplement in c...
Detailed Description
Research Design: Study participants (N=85) will be entered into the study and randomized to the flavonoid or placebo supplement groups for 2 weeks, with these two independent groups run in parallel (w...
Eligibility Criteria
Inclusion
- Females and males, 18 to 50 years of age
- Body mass index \<35 kg/m2 (i.e., not moderately or severely obese)
- Body weight of 100 pounds and greater
- Willing to consume during the study less than 5 servings/day fruits and vegetables, less than 2 cups/day coffee, and no green tea.
- Willing to avoid use of non-steroidal anti-inflammatory drugs (NSAIDs), and all dietary and herbal supplements for the 2-week study (and starting one week prior to the study).
- Walkers: Regular history of walking (\>100 min/week totaling all walking, both short or long duration episodes) and capable of walking 45 min briskly on a treadmill
- Runners: History of participating in 10 km to 42.2 km races and capable of running for 2.5 h on a treadmill.
- Non-smoker.
- Generally healthy and without chronic disease including cardiovascular disease (e.g., heart disease, stroke), cancer, type 1 and 2 diabetes, rheumatoid arthritis.
- Willing to maintain normal physical activity and diet habits, and make no formal attempts to lose weight during the 2-week study.
Exclusion
- Use of aspirin or non-steroidal anti-inflammatory drugs (NSAIDs) \[e.g. ibuprofen (Advil, Motrin, Nuprin), naproxen (Aleve, Naprosyn), and COX-2 inhibitors (Celebrex)\] within one week prior to the study, and/or intent to use these drugs during the 2-week period of the study.
- Regular use of fish oil supplements, omega 3 supplements, or omega 3-based drugs (Lovaza, etc.) during the past one to two weeks and plans to use these supplements during the study.
- Pregnant or breastfeeding.
- Currently on a weight reducing plan or using weight-loss medications (e.g., selective serotonin reuptake inhibitors, steroids, Ritalin, appetite suppressors, Xenical, Diethylpropion), and plans to continue during the 2-week period of the study.
- Regular use of large dose nutrient, herbal, and dietary supplements during the past one to two weeks, and plans to use these during the 2-week period of the study.
Key Trial Info
Start Date :
June 5 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2017
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03249571
Start Date
June 5 2017
End Date
August 30 2017
Last Update
October 11 2017
Active Locations (1)
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1
North Carolina Research Campus, Human Performance Lab
Kannapolis, North Carolina, United States, 28081