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OpenTrials
Completed

NCT Number: NCT00999297

Effect of 4-week Dihydrocapsiate Ingestion on Resting Metabolic Rate

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70809, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Dihydrocapsiate

Other

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

Other names: Natural Substances present in chili pepper

Primary outcomes

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

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Collaborators

  • Ajinomoto USA, INC.

Registry information

Official study title

Effect of 4-week Dihydrocapsiate Ingestion on Resting Metabolic Rate: A Double-blind Randomized Parallel Arm Study

Acronym: CAPSPAL

Important dates

Study start
2008
Primary completion
2009
Study completion
2014
First posted
Oct 21, 2009
Registry last updated
Nov 20, 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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