Bioenhancing Effects of Black Pepper With Turmeric on Pain Ratings

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

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Other: Turmeric; Other: Turmeric+Black Pepper

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Turmeric, then Turmeric+Black Pepper; Participants first receive Turmeric (Turmeric provided at 300mg, 1g or 3g; n=10 subjects/amount with no black pepper) for 1 week. After a 1 week washout, participants then receive Turmeric at the previous amount plus Black Pepper (Turmeric provided at 300mg, 1g or 3g daily; n=10 subjects/amount and Black Pepper 300mg/subject daily) for 1 week.	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.; Other: Turmeric+Black Pepper; Three amounts of dietary turmeric (300mg/day, 1g/day or 3g/day) with black pepper (300 mg) added to the turmeric.
Experimental: Turmeric+Black Pepper, then Turmeric; Participants first receive Turmeric+Black Pepper (Turmeric provided at 300mg, 1g or 3g daily; n=10 subjects/amount and Black Pepper at 300mg/subject daily) for 1 week. After a 1 week washout, participants then receive Turmeric daily at the previous amount for 1 week (Turmeric provided at 300mg, 1g or 3g; n=10 subjects/amount with no black pepper).	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.; Other: Turmeric+Black Pepper; Three amounts of dietary turmeric (300mg/day, 1g/day or 3g/day) with black pepper (300 mg) added to the turmeric.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Pain Survey		Once per week during the 3 week (21-day) study
Insulin	(uU/ml)	Baseline and every 7 days during the 21-day study
C-reactive protein	(ug/ml)	Baseline and every 7 days during the 21-day study
IL-6	Interleukin 6 (pg/ml)	Baseline and every 7 days during the 21-day study
IL-10	Interleukin 10 (pg/ml)	Baseline and every 7 days during the 21-day study

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: McCormick Science Institute

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2022
• Primary Completion (Actual): May 30, 2023
• Study Completion (Actual): June 16, 2023

Study Registration Dates

• First Submitted: December 13, 2021
• First Submitted That Met QC Criteria: January 24, 2022
• First Posted (Actual): January 25, 2022

Study Record Updates

• Last Update Posted (Actual): July 5, 2023
• Last Update Submitted That Met QC Criteria: July 3, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Antioxidants; Turmeric extract
• Other Study ID Numbers: IRB-300005070

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual de-identified participant data (including data dictionaries) will be shared or made publicly available for any publication of findings.
• IPD Sharing Time Frame: Immediately following publication.
• IPD Sharing Access Criteria: Public repository

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No