Effect of 4-week Dihydrocapsiate Ingestion on Resting Metabolic Rate (CAPSPAL)

Pennington Biomedical Research Center

Status: Completed

Conditions: Obesity; Weight

Treatments: Other: Dihydrocapsiate

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00999297

PBRC 28016

PBRC28016 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 79 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

79 participants in 3 patient groups, including a placebo group

Sugar pill (Placebo o mg/d)

Placebo Comparator group

Description:

0 mg/d sugar pill

Treatment:

Other: Dihydrocapsiate

Other: Dihydrocapsiate

Other: Dihydrocapsiate

Dihydrocapsiate

Active Comparator group

Description:

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

Treatment:

Other: Dihydrocapsiate

Other: Dihydrocapsiate

Other: Dihydrocapsiate

3 mg/d or 9 mg/d Dihydrocapsiate

Active Comparator group

Description:

Drug including Placebo

Treatment:

Other: Dihydrocapsiate

Other: Dihydrocapsiate

Other: Dihydrocapsiate