Clinical trial NCT05206266: Bioenhancing Effects of Black Pepper With Turmeric on Pain Ratings
Official title: Bioenhancing Effects of Black Pepper With Turmeric on Pain Ratings: a Randomized, Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: McCormick Science Institute
First posted: 2022-01-25
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Pain Intensity
timeFrame: 7 days
Secondary outcomes:
measure: Physical Activity
timeFrame: 7 days
measure: Pain Survey
timeFrame: Once per week during the 3 week (21-day) study
measure: Insulin
timeFrame: Baseline and every 7 days during the 21-day study
measure: C-reactive protein
timeFrame: Baseline and every 7 days during the 21-day study
measure: IL-6
timeFrame: Baseline and every 7 days during the 21-day study
measure: IL-10
timeFrame: Baseline and every 7 days during the 21-day study
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
References: