Effect of Dihydrocapsiate on Energy Expenditure in Women

Ellen Evans

Status: Completed

Conditions: Obesity

Treatments: Dietary Supplement: Dihydrocapsiate

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01773356

WASABI

Details and patient eligibility

About

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

Full description

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.

Enrollment: 126 patients

Sex: Female

Ages: 25 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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126 participants in 2 patient groups, including a placebo group

Placebo 0 mg/d

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Dihydrocapsiate

Dihydrocapsiate 9 mg/d

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Dihydrocapsiate