The Acute Effect of Grains of Paradise (Aframomum Melegueta) on REE

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: Obesity
• Intervention / Treatment: Dietary supplement: Grains of Paradise (Aframomum Melegueta)

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Not Applicable

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Dietary supplement: Grains of Paradise (Aframomum Melegueta); This is a randomized, double blind, crossover design testing the effect of grains of paradise on resting energy metabolism
Experimental: Grains of Paradise	Dietary supplement: Grains of Paradise (Aframomum Melegueta); 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)	Metabolic cart (metabolic gas exchange, indirect calorimitry)	3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resting substrate oxidation	Metabolic cart (respiratory exchange ratio)	3 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart Rate (beats per minute)	pulse frequency over time	3 weeks
Blood Pressure (mmHg)	automatic blood pressure cuff	3 weeks

Collaborators and Investigators

• Sponsor: Plexus Worldwide
• Collaborators: George Mason University

Study record dates

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

• Keywords: energy metabolism; Grains of Paradise; substrate oxidation
• 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