Effect of Dihydrocapsiate on Energy Expenditure in Women

September 24, 2015 updated by: Ellen Evans

Randomized, Controlled, Parallel Trial to Evaluate the Effects of Dihydrocapsiate on Energy Expenditure in Women

The objective of this study is to test the effect of dihydrocapsiate on energy expenditure in women.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Capsaicin, a substance found in chili pepper, is known to stimulate thermogenesis. Dihydrocapsiate, a capsinoid, found in the non-pungent CH-19 sweet pepper has similar thermogenic effects without the gastrointestinal side effects. The objective of this project is to test the effect of 12 weeks of daily consumption of 9 mg dihydrocapsiate on resting energy expenditure relative to baseline when compared to a control group consuming products without DCT.

Study Type

Interventional

Enrollment (Actual)

126

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

  • United States
    • Georgia
      • Athens, Georgia, United States, 30602-6554
        • University of Georgia, Department of Kinesiology

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

23 years to 43 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • BMI: 18.5-34.5 kg/m2
  • Good general health
  • Low to mild physical activity
  • Willing to maintain habitual diet and physical activity patterns throughout the study period
  • Premenopausal and cycling regularly or using oral contraceptives
  • Willing to attend study visits only during the follicular phase or bleed phase of their menstrual cycle
  • Understands study procedures and signs forms providing informed consent to participate in the study
  • Have spoken and written English literacy

Exclusion Criteria:

  • Diabetes mellitus or any conditions that might affect energy metabolism
  • Weight change ±2 kg over previous three months
  • Known sensitivity or allergy to ingredients of the study products
  • Non-breakfast eater
  • Recent use of antibiotics
  • History of smoking during the six months prior to study
  • Recent signs or symptoms of infection, including cold or flu-like symptoms
  • Concurrent or recent intervention study participation
  • Instability in breathing patterns or energy expenditure measures
  • History of drug or alcohol abuse
  • Lipid-lowering, anti-hypertensive or anti-inflammatory steroid medication use
  • Weight loss medication
  • Pregnant or lactating
  • Unwilling to be randomized to any experimental group and unable to meet all requirements of the study

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo 0 mg/d
0 mg/d of Dihydrocapsiate will be consumed in ready to ear cereal, cereal bars or crackers
Dietary supplement: Dihydrocapsiate
Kellogg's ready to eat cereal, cereal bars, and crackers will contain dihyrocapsiate or placebo. Daily consumption of dihydrocapsiate is 9mg/d or 0mg/d.
Other Names:
  • Natural substances present in sweet chili peppers
Active Comparator: Dihydrocapsiate 9 mg/d
9 mg/d of Dihydrocapsiate will be consumed in ready to ear cereal, cereal bars or crackers
Dietary supplement: Dihydrocapsiate
Kellogg's ready to eat cereal, cereal bars, and crackers will contain dihyrocapsiate or placebo. Daily consumption of dihydrocapsiate is 9mg/d or 0mg/d.
Other Names:
  • Natural substances present in sweet chili peppers

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Resting Energy Expenditure
Time Frame: Change from Baseline at 12 weeks
Change from Baseline at 12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Thermic effect of feeding
Time Frame: Change from baseline at 12 weeks
Change from baseline at 12 weeks
Body Composition
Time Frame: Change from baseline at 12 weeks
Change from baseline at 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ellen Evans

Collaborators

Kellogg Company

Investigators

  • Principal Investigator: Ellen M Evans, Ph.D., University of Georgia

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

January 1, 2011

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

January 15, 2013

First Submitted That Met QC Criteria

January 17, 2013

First Posted (Estimate)

January 23, 2013

Study Record Updates

Last Update Posted (Estimate)

September 25, 2015

Last Update Submitted That Met QC Criteria

September 24, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WASABI

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.

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