Bioenhancing Effects of Black Pepper With Turmeric on Pain Ratings: a Randomized, Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Pain Intensity
研究概览
简要总结
Although multiple clinical trials have been reported studying the effects of turmeric and turmeric-derived curcuminoid containing extract on pain by various study designs (including both acute and chronic pain), with the most consistent positive pain reduction benefits at turmeric or curcuminoid levels above normal dietary intake estimates, studies assessing the combination of black pepper and turmeric at culinary relevant levels for pain remediation benefits are needed. As black pepper is reported to 'enhance' the effects of co-consumed compounds, we are testing whether consumption of black pepper alters the pain alleviating effects of turmeric when consumed at levels representative of potential dietary intakes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 40 or older
- •BMI: 20-40
- •Diet: No dietary prohibitions/allergies
- •21-day availability
- •Moderate Pain Rating (self-reported numeric rating 4-7 on 10 pt scale)
排除标准
- •Turmeric or Black Pepper Allergy, or any allergy that would prevent menu item selections for 7 days of feeding
- •Recent change in pain levels - e.g. acute injury
- •Known eating disorder
- •No access to a phone capable of text message, electronic device (phone, tablet, computer/laptop) with email and internet access
- •Inability to continue on protocol for 3 consecutive weeks.
- •Medical conditions (cardiovascular disease event within the past six months, severe pulmonary disease, renal failure, major liver dysfunction within the last 2 years, digestive disorders including gastric reflux, irritable bowel disease, Crohn's disease or related conditions current smoker or recently quit less than 6 months prior) or medications that would prevent the ability to comply with treatment assignment (e.g. blood thinners, arrhythmia control medications, prescription narcotic pain medications).
- •Use of estrogen or testosterone replacement therapy within the past 6 months,
- •Current use of oral corticosteroids > 5 days/month on average
- •Cold, flu, virus, allergy or other conditions that impairs sensory perceptions (taste and smell) which may impact protocol compliance
- •COVID19 positive status at time of enrollment
- •Consumes an average of ≥1 serving of turmeric per day, or has never consumed and/or would not be willing to consume turmeric
- •Consumes black pepper ≥ 3 servings per day and/or would not be willing to abstain from pepper consumption for the prescribed days during the study
- •Abstinence from or dislike of either turmeric or black pepper
- •Dependence on others for food procurement and preparation
结局指标
主要结局
Pain Intensity
时间窗: 7 days
Self-reported pain according to Numeric Rating Scale (NRS), score from 0 = no pain, 10 = worst pain, within each 7-day intervention (placebo, turmeric, turmeric+black pepper)
次要结局
- Physical Activity(7 days)
- IL-6(Baseline and every 7 days during the 21-day study)
- Pain Survey(Once per week during the 3 week (21-day) study)
- C-reactive protein(Baseline and every 7 days during the 21-day study)
- IL-10(Baseline and every 7 days during the 21-day study)
- Insulin(Baseline and every 7 days during the 21-day study)
研究者
Daniel L. Smith, Jr.
Assistant Professor
University of Alabama at Birmingham