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

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ClinicalTrials.gov Identifier: NCT03894137
Recruitment Status : Not yet recruiting
First Posted : March 28, 2019
Last Update Posted : March 28, 2019
Sponsor:
Collaborator:
George Mason University
Information provided by (Responsible Party):
Plexus Worldwide

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Obesity Dietary Supplement: Grains of Paradise (Aframomum Melegueta) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Acute Effect of Grains of Paradise (Aframomum Melegueta) on Resting Energy Expenditure in Lean, Healthy, Adults
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : May 2020

Arm Intervention/treatment
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

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




Primary Outcome Measures :
  1. Resting metabolic Rate (Liters of oxygen consumed per minute) [ Time Frame: 3 weeks ]
    Metabolic cart (metabolic gas exchange, indirect calorimitry)


Secondary Outcome Measures :
  1. Resting substrate oxidation [ Time Frame: 3 weeks ]
    Metabolic cart (respiratory exchange ratio)


Other Outcome Measures:
  1. Heart Rate (beats per minute) [ Time Frame: 3 weeks ]
    pulse frequency over time

  2. Blood Pressure (mmHg) [ Time Frame: 3 weeks ]
    automatic blood pressure cuff



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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Responsible Party: Plexus Worldwide
ClinicalTrials.gov Identifier: NCT03894137     History of Changes
Other Study ID Numbers: 1355504-1
First Posted: March 28, 2019    Key Record Dates
Last Update Posted: March 28, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Plexus Worldwide:
Grains of Paradise
energy metabolism
substrate oxidation