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

NCT03894137 | Unknown

• 1 other identifier: 1355504-1
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obesity

Keywords

Grains of Paradise; energy metabolism; substrate oxidation

Outcome Measures

Primary Outcomes (1)

• Resting metabolic Rate (Liters of oxygen consumed per minute)

  Metabolic cart (metabolic gas exchange, indirect calorimitry)

  3 weeks

Secondary Outcomes (1)

• Resting substrate oxidation

  3 weeks

Other Outcomes (2)

• Heart Rate (beats per minute)

  3 weeks

• Blood Pressure (mmHg)

  3 weeks

Study Arms (2)

Grains of Paradise

EXPERIMENTAL

Dietary Supplement: Grains of Paradise (Aframomum Melegueta)

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Grains of Paradise (Aframomum Melegueta)

Interventions

Grains of Paradise (Aframomum Melegueta) DIETARY_SUPPLEMENT

This is a randomized, double blind, crossover design testing the effect of grains of paradise on resting energy metabolism

Grains of Paradise; Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Plexus Worldwide: lead
• George Mason University: collaborator

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2019
• First Posted: March 28, 2019
• Study Start: October 1, 2019
• Primary Completion: March 1, 2020
• Study Completion: May 1, 2020
• Last Updated: March 28, 2019

Record last verified: 2019-03