Skip to main content
OpenTrials
Completed

NCT Number: NCT05206266

Bioenhancing Effects of Black Pepper With Turmeric on Pain Ratings

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

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

Primary outcomes

  1. Pain Intensity

    Time frame: 7 days

    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)

Secondary outcomes

  1. Physical Activity

    Time frame: 7 days

    Minutes of physical activity per week at moderate and vigorous intensity physical activity levels, and minutes of sedentary behavior, assessed via accelerometry

  2. Pain Survey

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

  3. Insulin

    Time frame: Baseline and every 7 days during the 21-day study

    (uU/ml)

  4. C-reactive protein

    Time frame: Baseline and every 7 days during the 21-day study

    (ug/ml)

  5. IL-6

    Time frame: Baseline and every 7 days during the 21-day study

    Interleukin 6 (pg/ml)

  6. IL-10

    Time frame: Baseline and every 7 days during the 21-day study

    Interleukin 10 (pg/ml)

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • McCormick Science Institute

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 25, 2022
Registry last updated
Jul 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.