Capsaicin Energy Expenditure and Glucose Metabolism
CAPS
Capsaicin Consumption on Resting Energy Expenditure and Glucose Metabolism
1 other identifier
interventional
30
1 country
1
Brief Summary
The aim of the study is to investigate the effects of capsaicin rich foods on resting energy expenditure and substrate oxidation. We plan to recruit 30 healthy lean and overweight individuals age 18-45 (women) and age 18-50 (men) who will undergo two test days in random order. During one day they will receive a breakfast of toast, orange juice and an omelette with 4tsp of cayenne pepper while on the other day they will receive the same breakfast without the cayenne pepper. Metabolic rate and Respiratory quotients is measured for 30 minutes before the meal and for 2 hours after the meal. Capillary glucose levels and heart rate and blood pressure are measured before the meal and every 30 minutes thereafter for 2 hours.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable obesity
Started May 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 29, 2018
CompletedFirst Submitted
Initial submission to the registry
February 27, 2019
CompletedFirst Posted
Study publicly available on registry
March 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2019
CompletedMarch 1, 2019
February 1, 2019
1.2 years
February 27, 2019
February 28, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Postprandial substrate oxidation
The change in substrate oxidation after a meal as measured by the ratio of carbondioxide production and oxygen consumption measured by indirect calorimetry
3 hours
Secondary Outcomes (1)
postprandial energy expenditure
3 hrs
Study Arms (2)
Capsaicin
EXPERIMENTAL4 tsp of cayenne pepper in a 60g omelette
Control
PLACEBO COMPARATOR60 g omelette
Interventions
Eligibility Criteria
You may qualify if:
- years of age females or 18-50 males
- Generally healthy non-diabetic overweight or obese men and women
- BMI 23-33 kg/m2
- Willing to abstain from caffeine and alcohol for 3 days prior to testing
- Able to provide written consent in English
- Ability to communicate in English (oral and written)
You may not qualify if:
- BMI \< 23 kg/m2 or \>33 kg/m2
- Pregnant or Nursing
- Taking prescribed or over the counter medication affecting fluid balance or metabolism
- Suffers from hepatic, renal, pulmonary, endocrine or hematological disease
- Performs more than 3 hours a week of strenuous exercise
- Consumes, on average, more than 2 alcoholic beverages per day
- More than 5 kg of weight change over the past 6 months
- Claustrophobic
- Consumes capsaicin foods habitually 3x/week
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
George Mason University
Fairfax, Virginia, 22030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- assistant professor
Study Record Dates
First Submitted
February 27, 2019
First Posted
March 1, 2019
Study Start
May 29, 2018
Primary Completion
August 1, 2019
Study Completion
August 1, 2019
Last Updated
March 1, 2019
Record last verified: 2019-02