ObesityNCT01729143
Impact of Black Pepper on Energy Expenditure and Substrate Utilization
A study testing 24-hour energy expenditure and substrate utilization in people with Obesity, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- 24-hour energy expenditure and substrate utilization
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Jul 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Smoker
- Heavy exerciser (defined as >150 minutes/week for more than 3 months)
- Abuses alcohol or drugs
- Vegetarian
Trial locations and contacts
1 site in 1 country.
United States1 site
UNC Chapel Hill Nutrition Research Institute
Kannapolis, North Carolina, 28081
About this study
Official title: 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).
- Conditions
- Obesity
- Being tested
- 24-hour energy expenditure and substrate utilization
- Keywords
- black pepper, metabolic chamber, respiratory chamber
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
24-hour energy expenditure and substrate utilizationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Black pepper | Active comparator | 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. Receives: Other: 24-hour energy expenditure and substrate utilization |
| No pepper control | Placebo comparator | 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. Receives: Other: 24-hour energy expenditure and substrate utilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy expenditure and substrate oxidation
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.
Measured: 24-hours
Secondary outcomes (1)
Gut peptides
Change in gut peptide secretion 30 minutes following a meal containing black pepper compared with no pepper control.
Measured: 30 minutes after lunch
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2012 (estimated)
- Study startApr 2011
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Appalachian State University
- Responsible party
- Sponsor
- Investigators
- Andrew G Swick, PhD, Principal investigator, UNC Chapel Hill Nutrition Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01729143
- Sponsor's protocol ID
- 11-0468
- Status last verified
- Nov 2012
- First submitted
- 13 Nov 2012
- Last updated
- 6 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Swick AG, Orena S, O'Connor A. Irisin levels correlate with energy expenditure in a subgroup of humans with energy expenditure greater than predicted by fat free mass. Metabolism. 2013 Aug;62(8):1070-3. doi: 10.1016/j.metabol.2013.02.012. Epub 2013 Apr 8.
PubMed 23578923
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Cross-Over Trial to Evaluate the Acute Effects of Black Pepper on Energy Expenditure and Fat Oxidation in Humans
- ClinicalTrials.gov ID
- NCT01729143
- Acronym / sponsor ID
- 11-0468
- Conditions
- Obesity
- Keywords
- black pepper, metabolic chamber, respiratory chamber
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Appalachian State University
- Study start
- Apr 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 20 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Black pepper | Active comparator | Other: 24-hour energy expenditure and substrate utilizationDuring 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. |
| No pepper control | Placebo comparator | Other: 24-hour energy expenditure and substrate utilizationDuring 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. |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- Smoker
- Heavy exerciser (defined as >150 minutes/week for more than 3 months)
- Abuses alcohol or drugs
- Vegetarian
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 24-hour energy expenditure and substrate utilizationSubjects 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. | Other | Black pepper, No pepper control |
Primary outcome
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.
1 secondary outcome
Gut peptides
Time frame: 30 minutes after lunch
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2016.
- Derived from this study: PubMed 23578923Swick AG, Orena S, O'Connor A. Irisin levels correlate with energy expenditure in a subgroup of humans with energy expenditure greater than predicted by fat free mass. Metabolism. 2013 Aug;62(8):1070-3. doi: 10.1016/j.metabol.2013.02.012. Epub 2013 Apr 8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew G Swick, PhD principal investigator
UNC Chapel Hill Nutrition Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 24-hour energy expenditure and substrate utilization in people with Obesity, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Energy expenditure and substrate oxidation (time frame: 24-hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01729143, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2016.