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

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.

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.

Clinical Trials on Obesity

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