ClinicalTrials.gov
ClinicalTrials.gov Menu

Impact of Black Pepper on Energy Expenditure and Substrate Utilization

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01729143
Recruitment Status : Completed
First Posted : November 20, 2012
Last Update Posted : April 6, 2016
Sponsor:
Collaborator:
Appalachian State University
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief Summary:
As obesity rates worldwide continue to increase, there is a focus on identifying active food ingredients which increase metabolic rate which can be used as a dietary supplement in the treatment of overweight and obesity. Promising animal and cell studies have suggested a role for black pepper and an active component of black pepper, piperine, in energy expenditure. However, the effects of black pepper have not been determined in humans. The investigators hypothesis if that consumption of 1.5g black pepper (0.5g in each of three meals over one day) will result in an elevation in 24-h resting energy expenditure when contrasted to a control day (no black pepper, same diet intake).

Condition or disease Intervention/treatment Phase
Obesity Other: 24-hour energy expenditure and substrate utilization Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Randomized, Cross-Over Trial to Evaluate the Acute Effects of Black Pepper on Energy Expenditure and Fat Oxidation in Humans
Study Start Date : April 2011
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Black pepper
During the black pepper study day, subjects consumed 1.5g of black pepper (0.5g/meal) in 60.8g of vegetable juice. Black pepper was consumed was a meal on each occasion. 24-hour energy expenditure and substrate utilization will be measured.
Other: 24-hour energy expenditure and substrate utilization
Subjects spent two x 24-hour periods inside the metabolic chamber at the UNC NRI (black pepper and no pepper control) each separated by one week. Subjects were requested to arrive at the study center each morning in a fasted state (at least 10 hours). During each study day, subjects remained sedentary. All meals were provided and were tailored to each subject's specific energy requirements. Study meals (with the exception of the 1.5g of black pepper) were identical between the black pepper and no pepper control study days.

Placebo Comparator: No pepper control
During the no pepper control study day, subjects consumed an identical menu without black pepper. 60.8g of vegetable juice (vehicle) was consumed at each of the three study meals. 24-hour energy expenditure and substrate utilization will be measured.
Other: 24-hour energy expenditure and substrate utilization
Subjects spent two x 24-hour periods inside the metabolic chamber at the UNC NRI (black pepper and no pepper control) each separated by one week. Subjects were requested to arrive at the study center each morning in a fasted state (at least 10 hours). During each study day, subjects remained sedentary. All meals were provided and were tailored to each subject's specific energy requirements. Study meals (with the exception of the 1.5g of black pepper) were identical between the black pepper and no pepper control study days.




Primary Outcome Measures :
  1. Energy expenditure and substrate oxidation [ Time Frame: 24-hours ]
    A primary outcome of this study was the 24-hour energy expenditure (measured in the metabolic chamber at the UNC NRI) following black pepper and no pepper control.


Secondary Outcome Measures :
  1. Gut peptides [ Time Frame: 30 minutes after lunch ]
    Change in gut peptide secretion 30 minutes following a meal containing black pepper compared with no pepper control.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Woman
  • Postmenopausal
  • Aged 50-65 years
  • BMI 25-35kg/m2
  • Not taking blood pressure or anti-inflammatory medications or any other medications that may impact the results
  • Thyroid hormone profile within the normal reference range
  • No medical condition which may impact the results (e.g. diabetes)
  • Accustomed to eating regular meals including breakfast

Exclusion Criteria:

  • Smoker
  • Heavy exerciser (defined as >150 minutes/week for more than 3 months)
  • Abuses alcohol or drugs
  • Vegetarian

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01729143


Locations
United States, North Carolina
UNC Chapel Hill Nutrition Research Institute
Kannapolis, North Carolina, United States, 28081
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Appalachian State University
Investigators
Principal Investigator: Andrew G Swick, PhD UNC Chapel Hill Nutrition Research Institute

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01729143     History of Changes
Other Study ID Numbers: 11-0468
First Posted: November 20, 2012    Key Record Dates
Last Update Posted: April 6, 2016
Last Verified: November 2012

Keywords provided by University of North Carolina, Chapel Hill:
black pepper
metabolic chamber
respiratory chamber