Flavonoid-rich Supplement Influence on the Human Metabolome

Completed · Not applicable · Has a placebo group

Conditions studied: Inflammation

In brief

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.

Key facts

Study ID

NCT03004742

Run by

Appalachian State University

People needed

110

Starts

2015-08-01

Expected to finish

2016-12-01

Last updated by the study team

2017-02-02

Who can join

Age: 18 and older, up to 65. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Appalachian State University Human Performance Lab, North Carolina Research Campus — Kannapolis, North Carolina, United States

Full record on ClinicalTrials.gov

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