Bioenhancing Effects of Black Pepper With Turmeric on Pain Ratings

Pain Clinical Trial

Official title:

Bioenhancing Effects of Black Pepper With Turmeric on Pain Ratings: a Randomized, Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05206266
• Other study ID #: IRB-300005070
• Status: Completed
• Phase: N/A
• Start date: February 13, 2022
• Est. completion date: June 16, 2023

Study information

• Verified date: July 2023
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 16, 2023
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

Other:
• Turmeric
Three amounts of dietary turmeric will be tested: 1) turmeric 300 mg/day, 2) turmeric 1 g/day, 3) turmeric 3 g/day.
• Turmeric+Black Pepper
Three amounts of dietary turmeric (300mg/day, 1g/day or 3g/day) with black pepper (300 mg) added to the turmeric.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	McCormick Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Intensity	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)	7 days
Secondary	Physical Activity	Minutes of physical activity per week at moderate and vigorous intensity physical activity levels, and minutes of sedentary behavior, assessed via accelerometry	7 days
Secondary	Pain Survey		Once per week during the 3 week (21-day) study
Secondary	Insulin	(uU/ml)	Baseline and every 7 days during the 21-day study
Secondary	C-reactive protein	(ug/ml)	Baseline and every 7 days during the 21-day study
Secondary	IL-6	Interleukin 6 (pg/ml)	Baseline and every 7 days during the 21-day study
Secondary	IL-10	Interleukin 10 (pg/ml)	Baseline and every 7 days during the 21-day study