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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Body Weight
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on November 25, 2014