Inflammation Clinical Trial
Official title:
Influence of Ingesting a Flavonoid-rich Supplement on the Human Metabolome and Concentration of Urine Phenolics
Verified date | January 2017 |
Source | Appalachian State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will measure the effect of ingesting a flavonoid-rich supplement on various biomarkers in overweight/obese women during a 12-week period. The flavonoid-rich supplement contains a mixture of flavonoids including quercetin, catechins from green tea extract, and anthocyanins from bilberry extract, and other food components that facilitate flavonoid bioactivity including fish oil, caffeine, and vitamin C.
Status | Completed |
Enrollment | 110 |
Est. completion date | December 2016 |
Est. primary completion date | June 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - BMI 25 kg/m2 and higher (about 25 pounds or more overweight from recommended levels) - Generally healthy and without chronic disease including cardiovascular disease (e.g., heart disease, stroke), cancer, type 1 diabetes, rheumatoid arthritis - Willingness to maintain normal physical activity and diet habits, and make no formal attempts to lose weight during the 12-week study. Exclusion Criteria: - Use of Aspirin and non-steroidal anti-inflammatory drugs (NSAIDs) within the past one to two weeks, and plans to use NSAIDs during the 12-week period of the study. Examples include ibuprofen (Advil, Motrin, Nuprin), naproxen (Aleve, Naprosyn), and COX-2 inhibitors (Celebrex). - 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. - History of allergy or intolerance to green tea, blueberries, fish oil, caffeine, or the flavonoid quercetin. - 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 12-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 12-week period of the study. |
Country | Name | City | State |
---|---|---|---|
United States | Appalachian State University Human Performance Lab, North Carolina Research Campus | Kannapolis | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Appalachian State University | Reoxcyn Discoveries Group |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Urine phenolics | 24-h urine samples collected pre-study and after 12-weeks intervention | Change from baseline urine phenolics at 12 weeks | |
Secondary | Change in global metabolomics | Blood sample analysis for shifts in metabolites pre-study and after 12-weeks intervention | Change from baseline global metabolomics at 12 weeks | |
Secondary | Change in symptoms | A 4-week retrospective symptom log will be administered pre-study, 4-weeks, 8-weeks, and 12-weeks to document potential adverse gastrointestinal and mental effects. | Change from baseline symptoms at 4-weeks, 8-weeks, 12-weeks. | |
Secondary | Change in oxidized LDL | plasma oxidized LDL | Change from baseline oxidized LDL at 12 weeks | |
Secondary | Change in blood diagnostic chemistries | Comprehensive blood diagnostic chemistry panels | Change from baseline diagnostic chemistries at 12 weeks | |
Secondary | Change in CRP | C-reactive protein | Change from baseline CRP at 12 weeks | |
Secondary | Change in IL-6 | Plasma IL-6 | Change from baseline IL-6 at 12 weeks | |
Secondary | Change in MCP-1 | Plasma MCP-1 | Change from baseline MCP-1 at 12 weeks | |
Secondary | Change in FRAP | Plasma FRAP | Change from baseline FRAP at 12 weeks |
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