Effect of Dihydrocapsiate on Energy Expenditure in Women

NCT ID: NCT01773356

Last Updated: 2015-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2014-03-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo 0 mg/d

0 mg/d of Dihydrocapsiate will be consumed in ready to ear cereal, cereal bars or crackers

Group Type PLACEBO_COMPARATOR

Dihydrocapsiate

Intervention Type 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.

Dihydrocapsiate 9 mg/d

9 mg/d of Dihydrocapsiate will be consumed in ready to ear cereal, cereal bars or crackers

Group Type ACTIVE_COMPARATOR

Dihydrocapsiate

Intervention Type 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.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Natural substances present in sweet chili peppers

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Kellogg Company

INDUSTRY

Sponsor Role collaborator

Ellen Evans

OTHER

Sponsor Role lead

Responsible Party

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Ellen Evans

Dr Ellen Evans

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Ellen M Evans, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Georgia

Locations

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University of Georgia, Department of Kinesiology

Athens, Georgia, United States

Site Status

Countries

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United States

Other Identifiers

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WASABI

Identifier Type: -

Identifier Source: org_study_id

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