Bioenhancing Effects of Black Pepper With Turmeric on Pain Ratings

NCT05206266 | Completed

• 1 other identifier: IRB-300005070
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Physical Activity

  7 days

• Pain Survey

  Once per week during the 3 week (21-day) study

• Insulin

  Baseline and every 7 days during the 21-day study

• C-reactive protein

  Baseline and every 7 days during the 21-day study

• IL-6

  Baseline and every 7 days during the 21-day study

Study Arms (2)

Turmeric, then Turmeric+Black Pepper

EXPERIMENTAL

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; Other: Turmeric+Black Pepper

Turmeric+Black Pepper, then Turmeric

EXPERIMENTAL

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; Other: Turmeric+Black Pepper

Interventions

Turmeric OTHER

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, then Turmeric; Turmeric, then Turmeric+Black Pepper

Turmeric+Black Pepper OTHER

Three amounts of dietary turmeric (300mg/day, 1g/day or 3g/day) with black pepper (300 mg) added to the turmeric.

Turmeric+Black Pepper, then Turmeric; Turmeric, then Turmeric+Black Pepper

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 40 or older
• BMI: 20-40
• Diet: No dietary prohibitions/allergies
• day availability
• Moderate Pain Rating (self-reported numeric rating 4-7 on 10 pt scale)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• McCormick Science Institute: collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Curcumin

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 13, 2021
• First Posted: January 25, 2022
• Study Start: February 13, 2022
• Primary Completion: May 30, 2023
• Study Completion: June 16, 2023
• Last Updated: July 5, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: Immediately following publication.
• Access Criteria: Public repository

Locations

US (1)