NCT01729143

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Apr 2011

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 13, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 20, 2012

Completed
Last Updated

April 6, 2016

Status Verified

November 1, 2012

Enrollment Period

3 months

First QC Date

November 13, 2012

Last Update Submit

April 5, 2016

Conditions

Obesity

Keywords

black peppermetabolic chamberrespiratory chamber

Outcome Measures

Primary Outcomes (1)

  • 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.

    24-hours

Secondary Outcomes (1)

  • Gut peptides

    30 minutes after lunch

Study Arms (2)

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.

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.

Other: 24-hour energy expenditure and substrate utilization

Interventions

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.

Black pepperNo pepper control

Eligibility Criteria

Age50 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UNC Chapel Hill Nutrition Research Institute

Kannapolis, North Carolina, 28081, United States

Location

Related Publications (1)

  • 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.

    PMID: 23578923DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Energy Metabolism

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Metabolism

Study Officials

  • Andrew G Swick, PhD

    UNC Chapel Hill Nutrition Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2012

First Posted

November 20, 2012

Study Start

April 1, 2011

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

April 6, 2016

Record last verified: 2012-11

Locations

US(1)