Influence of Ingesting a Flavonoid-rich Supplement on the Human Metabolome and Concentration of Urine Phenolics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Change in Urine phenolics
研究概览
简要总结
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.
详细描述
- The primary objective of this study is to evaluate the effect of ingesting a flavonoid-rich supplement on total urine polyphenol concentration and shifts in blood metabolites related to flavonoid intake in healthy but overweight/obese community-dwelling adults.
- Secondary objectives are to determine related effects on measures of inflammation and oxidative stress. Studies are mixed regarding the influence of flavonoid supplements on traditional biomarkers for inflammation and oxidative stress, and metabolite shifts from the metabolomics measurements may provide better insights. Chemistry profiles and symptom logs will be compared pre- and post-study between groups to confirm prior safety data collected on human participants.
Hypothesis: Subjects randomized to ingestion of the flavonoid-rich supplement compared to placebo will experience an increase in total urine polyphenols concentrations and shifts in blood metabolites related to increased flavonoid metabolism. Secondarily, subjects ingesting the flavonoid-rich supplement will experience a decrease in systemic inflammation and oxidative stress.
BASELINE TESTING (ASU-NCRC HUMAN PERFORMANCE LAB):
A. One week before the start of the study, subjects will report to the ASU-NCRC Human Performance Lab, be oriented to the study, and provide voluntary consent. Subjects will fill in a medical health questionnaire to verify medical history and lifestyle habits. Subjects must agree to maintain normal dietary and physical activity patterns during the 12-week intervention, and not make formal attempts to lose body weight. All other subject inclusion and exclusion criteria must be maintained during the study. Subjects will be instructed on how to record all food intake during a 3-day period prior to the start of the study (Thursday, Friday, and Sunday).
Subjects will be instructed on how to collect urine for 24-hours during the day just before the study starts. Urine collection guidelines:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change in Urine phenolics
时间窗: Change from baseline urine phenolics at 12 weeks
24-h urine samples collected pre-study and after 12-weeks intervention
次要结局
- Change in blood diagnostic chemistries(Change from baseline diagnostic chemistries at 12 weeks)
- Change in CRP(Change from baseline CRP at 12 weeks)
- Change in symptoms(Change from baseline symptoms at 4-weeks, 8-weeks, 12-weeks.)
- Change in MCP-1(Change from baseline MCP-1 at 12 weeks)
- Change in oxidized LDL(Change from baseline oxidized LDL at 12 weeks)
- Change in IL-6(Change from baseline IL-6 at 12 weeks)
- Change in global metabolomics(Change from baseline global metabolomics at 12 weeks)
- Change in FRAP(Change from baseline FRAP at 12 weeks)