- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03894137
The Acute Effect of Grains of Paradise (Aframomum Melegueta) on REE
March 26, 2019 updated by: Plexus Worldwide
The Acute Effect of Grains of Paradise (Aframomum Melegueta) on Resting Energy Expenditure in Lean, Healthy, Adults
Grains of paradise (Aframomumu melegueta) (GP), also known as Guinea pepper or Alligator pepper, belongs to the Zingiberaceae family, which is native to West Africa.
GP seeds are used as a spice and also have wide-ranging ethnobotanical uses.
GP seeds are very rich in non-volatile pungent compounds such as 6-paradol, 6-gingerol, 6-shogaol and related compounds.
This feature may equip them with the power to activate the Sympathetic Nervous System and thereby increase EE, which has been demonstrated in rodents.
Research suggest that ingestion of GP extract can result in sustained elevation of EE and a consequent reduction in body fat.
Thus, there is some evidence that GP may have a potential thermogenic effect that could be useful as part of a weight loss treatment.
However, there is no information on whether GP has the potential of improving and prolonging the thermogenic effects of bioactives known to elevate fatty acid mobilization and subsequent fat oxidation.
This proposal will fill a void in the literature by testing for the first time in healthy, normal weight, human volunteers whether the ingestion of GP in combination with a commercially available complex containing caffeine, green tea, and forskolin has an enhanced acute effect on REE, the largest and most stable component of EE, as well as the ratio of fat:carbohydrate oxidation.
This project will provide pilot data to support larger studies such as prospective studies and studies to compare the thermogenic effect with currently available compounds.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
15
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Ages 18-65 years
- Men and women
- Able to provide written consent in English
- A body mass index between 18.5 and 30 kg/m2
Exclusion Criteria:
- Current smoker
- Claustrophobia
- Use of any prescribed or over-the-counter medication affecting metabolism
- Suffering from cardiac, hepatic, renal, pulmonary, endocrine or hematological disease
- Currently pregnant or breastfeeding
- Consuming more than 300mg of caffeine per day
- Consuming more than 2 alcoholic beverages per day.
- Performing more than 3 hrs/week of strenuous exercise
- Weight loss of more than 5% of body weight over the past 6 months
- Not willing to abstain from alcohol, caffeine and exercise for 24hr before each test day.
- Suffering from heartburn or a sensitivity to pungent compounds in foods
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
This is a randomized, double blind, crossover design testing the effect of grains of paradise on resting energy metabolism
|
Experimental: Grains of Paradise
|
This is a randomized, double blind, crossover design testing the effect of grains of paradise on resting energy metabolism
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Resting metabolic Rate (Liters of oxygen consumed per minute)
Time Frame: 3 weeks
|
Metabolic cart (metabolic gas exchange, indirect calorimitry)
|
3 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Resting substrate oxidation
Time Frame: 3 weeks
|
Metabolic cart (respiratory exchange ratio)
|
3 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Heart Rate (beats per minute)
Time Frame: 3 weeks
|
pulse frequency over time
|
3 weeks
|
Blood Pressure (mmHg)
Time Frame: 3 weeks
|
automatic blood pressure cuff
|
3 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
October 1, 2019
Primary Completion (Anticipated)
March 1, 2020
Study Completion (Anticipated)
May 1, 2020
Study Registration Dates
First Submitted
March 25, 2019
First Submitted That Met QC Criteria
March 26, 2019
First Posted (Actual)
March 28, 2019
Study Record Updates
Last Update Posted (Actual)
March 28, 2019
Last Update Submitted That Met QC Criteria
March 26, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- 1355504-1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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