Effect of Dihydrocapsiate on Energy Expenditure in Women

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Kellogg Company
Information provided by (Responsible Party):
Ellen Evans, University of Georgia
ClinicalTrials.gov Identifier:
NCT01773356
First received: January 15, 2013
Last updated: October 31, 2013
Last verified: October 2013
  Purpose

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


Condition Intervention
Obesity
Dietary Supplement: Dihydrocapsiate

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Randomized, Controlled, Parallel Trial to Evaluate the Effects of Dihydrocapsiate on Energy Expenditure in Women

Resource links provided by NLM:


Further study details as provided by University of Georgia:

Primary Outcome Measures:
  • Resting Energy Expenditure [ Time Frame: Change from Baseline at 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Thermic effect of feeding [ Time Frame: Change from baseline at 12 weeks ] [ Designated as safety issue: No ]
  • Body Composition [ Time Frame: Change from baseline at 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 126
Study Start Date: January 2011
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Natural substances present in sweet chili peppers

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.

  Eligibility

Ages Eligible for Study:   25 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01773356

Locations
United States, Georgia
University of Georgia, Department of Kinesiology
Athens, Georgia, United States, 30602-6554
Sponsors and Collaborators
Ellen Evans
Kellogg Company
Investigators
Principal Investigator: Ellen M Evans, Ph.D. University of Georgia
  More Information

No publications provided

Responsible Party: Ellen Evans, Dr Ellen Evans, University of Georgia
ClinicalTrials.gov Identifier: NCT01773356     History of Changes
Other Study ID Numbers: WASABI
Study First Received: January 15, 2013
Last Updated: October 31, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Georgia:
Obesity
Body Weight
Body Composition
Metabolism
Resting Energy Expenditure

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014