- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01729143
Impact of Black Pepper on Energy Expenditure and Substrate Utilization
April 5, 2016 updated by: University of North Carolina, Chapel Hill
A Randomized, Cross-Over Trial to Evaluate the Acute Effects of Black Pepper on Energy Expenditure and Fat Oxidation in Humans
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Carolina
-
Kannapolis, North Carolina, United States, 28081
- UNC Chapel Hill Nutrition Research Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
24-hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
30 minutes after lunch
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Andrew G Swick, PhD, UNC Chapel Hill Nutrition Research Institute
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2011
Primary Completion (Actual)
July 1, 2011
Study Completion (Actual)
July 1, 2011
Study Registration Dates
First Submitted
November 13, 2012
First Submitted That Met QC Criteria
November 19, 2012
First Posted (Estimate)
November 20, 2012
Study Record Updates
Last Update Posted (Estimate)
April 6, 2016
Last Update Submitted That Met QC Criteria
April 5, 2016
Last Verified
November 1, 2012
More Information
Terms related to this study
Other Study ID Numbers
- 11-0468
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obesity
-
Central Hospital, Nancy, FranceNot yet recruiting
-
University of MinnesotaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Active, not recruitingAdolescent ObesityUnited States
-
Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
-
Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
-
Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsActive, not recruitingOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
-
The Hospital for Sick ChildrenCompleted
-
Ihuoma EneliCompletedObesity, ChildhoodUnited States
-
Fundació Sant Joan de DéuRecruitingObesity, Childhood | Obesity, AdolescentSpain
Clinical Trials on 24-hour energy expenditure and substrate utilization
-
University of North Carolina, Chapel HillCompletedObesityUnited States
-
Arizona State UniversityCompletedHypertension | Diabetes | Sleep
-
Pennington Biomedical Research CenterCompletedEnergy ExpenditureUnited States
-
Nanyang Technological UniversityMinistry of Education, SingaporeCompletedOverweight and ObesitySingapore
-
Cairo UniversityRecruitingSystemic Lupus ErythematosusEgypt
-
Linnaeus UniversityEnrolling by invitation
-
Medical University of LodzRecruitingPostoperative Complications | Postoperative Pain | Vitamin D Deficiency | Hypocalcemia | Hypoparathyroidism Postprocedural | Postoperative Nausea | Voice HoarsenessPoland
-
Hôpital CochinAssistance Publique - Hôpitaux de ParisCompleted
-
Mayo ClinicNational Institutes of Health (NIH)CompletedBarrett's EsophagusUnited States
-
University Hospital, Clermont-FerrandHopital Gabriel Montpied; Laboratoire Régional de Nutrition Humaine; Agrément...CompletedDiabetes | Insulin Resistance | Kidney Transplantation | Weight Gain | Chronic Renal FailureFrance