NCT00999297

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Jul 2008

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

October 20, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 21, 2009

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
5.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

November 20, 2015

Status Verified

November 1, 2015

Enrollment Period

1.3 years

First QC Date

October 20, 2009

Last Update Submit

November 18, 2015

Conditions

ObesityWeight

Keywords

thermogenesisrespiratory quotientfat oxidation

Outcome Measures

Primary Outcomes (1)

  • The consumption of dihydrocapsiate will significantly increase resting energy expenditure and fat oxidation

    4 weeks

Study Arms (3)

Sugar pill (Placebo o mg/d)

PLACEBO COMPARATOR

0 mg/d sugar pill

Other: Dihydrocapsiate

Dihydrocapsiate

ACTIVE COMPARATOR

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

Other: Dihydrocapsiate

3 mg/d or 9 mg/d Dihydrocapsiate

ACTIVE COMPARATOR

Drug including Placebo

Other: Dihydrocapsiate

Interventions

DihydrocapsiateOTHER

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

Also known as: Natural Substances present in chili pepper
Sugar pill (Placebo o mg/d)

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70809, United States

Location

Related Publications (2)

  • 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.

    PMID: 19671203RESULT

  • 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.

    PMID: 20826626DERIVED

Related Links

MeSH Terms

Conditions

ObesityBody Weight

Interventions

capsiate

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Eric Ravussin, PhD

    Pennington Biomedical Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 20, 2009

First Posted

October 21, 2009

Study Start

July 1, 2008

Primary Completion

November 1, 2009

Study Completion

December 1, 2014

Last Updated

November 20, 2015

Record last verified: 2015-11

Locations

US(1)