Bioenhancing Effects of Black Pepper With Turmeric on Pain Ratings

NCT ID: NCT05206266

Last Updated: 2023-07-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-13
• Study Completion Date: 2023-06-16

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Turmeric

Intervention Type: 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

Intervention Type: 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

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).

Group Type: EXPERIMENTAL

Turmeric

Intervention Type: 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

Intervention Type: OTHER

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

Interventions

Turmeric

Three amounts of dietary turmeric will be tested: 1) turmeric 300 mg/day, 2) turmeric 1 g/day, 3) turmeric 3 g/day.

Intervention Type: 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

McCormick Science Institute

INDUSTRY

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Daniel L. Smith, Jr.

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Countries

United States

Other Identifiers

IRB-300005070

Identifier Type: -

Identifier Source: org_study_id