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Completed

NCT Number: NCT01773356

Effect of Dihydrocapsiate on Energy Expenditure in Women

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

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Key information

Age range

25 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Georgia, Department of Kinesiology

Athens, Georgia, 30602-6554, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dihydrocapsiate

Dietary Supplement

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

Primary outcomes

  1. Resting Energy Expenditure

    Time frame: Change from Baseline at 12 weeks

Secondary outcomes

  1. Thermic effect of feeding

    Time frame: Change from baseline at 12 weeks

  2. Body Composition

    Time frame: Change from baseline at 12 weeks

Sponsors and collaborators

Lead sponsor

Ellen Evans

Other

Collaborators

  • Kellogg Company

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jan 23, 2013
Registry last updated
Sep 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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