Effect of 4-week Dihydrocapsiate Ingestion on Resting Metabolic Rate

NCT ID: NCT00999297

Last Updated: 2015-11-20

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

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2014-12-31

Brief Summary

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A 4 week intake of drug to find a natural substance that may modify energy balance and may enhance health in combination with lifestyle changes with possible decrease in body weight.

Detailed Description

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This study is a double-blind, placebo-controlled, single center, randomized, parallel arm clinical trial to test the impact of Dihydrocapsiate (placebo, 3 and 9 mg/d) ingested for 4 weeks on resting metabolic rate and fat oxidation measured by indirect calorimetry.

Conditions

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Obesity Weight

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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Sugar pill (Placebo o mg/d)

0 mg/d sugar pill

Group Type PLACEBO_COMPARATOR

Dihydrocapsiate

Intervention Type OTHER

Capsules will contain dihydrocapsiate 3 mg/d or 9 mg/d or placebo

Dihydrocapsiate

Drug 3 mg/d or 9 mg/d including Placebo

Group Type ACTIVE_COMPARATOR

Dihydrocapsiate

Intervention Type OTHER

Capsules will contain dihydrocapsiate 3 mg/d or 9 mg/d or placebo

3 mg/d or 9 mg/d Dihydrocapsiate

Drug including Placebo

Group Type ACTIVE_COMPARATOR

Dihydrocapsiate

Intervention Type OTHER

Capsules will contain dihydrocapsiate 3 mg/d or 9 mg/d or placebo

Interventions

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Dihydrocapsiate

Capsules will contain dihydrocapsiate 3 mg/d or 9 mg/d or placebo

Intervention Type OTHER

Dihydrocapsiate

Capsules will contain dihydrocapsiate 3 mg/d or 9 mg/d or placebo

Intervention Type OTHER

Dihydrocapsiate

Capsules will contain dihydrocapsiate 3 mg/d or 9 mg/d or placebo

Intervention Type OTHER

Other Intervention Names

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Natural Substances present in chili pepper Natural Substances present in chili pepper Natural Substances present in chili pepper

Eligibility Criteria

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Inclusion Criteria

* Men between 20-60 years old
* Healthy as assessed by medical history and standard medical exam
* Weight-stable
* Body mass index of 25 to 34.9 kg/m2
* Non-smoker
* Sedentary lifestyle: not being physically active grater than 3 days/week for 20 min each time for the previous 6 months, and not participating in regular resistance exercise.

Exclusion Criteria

* Subjects enrolled in a diet to increase or decrease body weight
* Special diet or food aversiions to common foods
* Has allergy to chilli pepper
* Eating chilli peppers on a daily basis
* Usually consuming more than 2 cups of tea or coffee/day
* Usually consuming more than 4 cans of caffeinated soft drinks a day
* Usually consuming more than 3 standard alcohol drinks/day
* Regular use of medications (weight loss drugs, drugs affecting energy metabolism, drugs for depression)
* Usual intake of illicit substances
* Claustrophobia
* Participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of this study
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ajinomoto USA, INC.

INDUSTRY

Sponsor Role collaborator

Pennington Biomedical Research Center

OTHER

Sponsor Role lead

Responsible Party

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Eric Ravussin

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eric Ravussin, PhD

Role: PRINCIPAL_INVESTIGATOR

Pennington Biomedical Research Center

Locations

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Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States

Site Status

Countries

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United States

References

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Galgani JE, Ryan DH, Ravussin E. Effect of capsinoids on energy metabolism in human subjects. Br J Nutr. 2010 Jan;103(1):38-42. doi: 10.1017/S0007114509991358. Epub 2009 Aug 12.

Reference Type RESULT
PMID: 19671203 (View on PubMed)

Galgani JE, Ravussin E. Effect of dihydrocapsiate on resting metabolic rate in humans. Am J Clin Nutr. 2010 Nov;92(5):1089-93. doi: 10.3945/ajcn.2010.30036. Epub 2010 Sep 8.

Reference Type DERIVED
PMID: 20826626 (View on PubMed)

Related Links

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Other Identifiers

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PBRC28016

Identifier Type: OTHER

Identifier Source: secondary_id

PBRC 28016

Identifier Type: -

Identifier Source: org_study_id