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

P

Plexus Worldwide

Status

Unknown

Conditions

Obesity

Treatments

Dietary Supplement: Grains of Paradise (Aframomum Melegueta)

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT03894137
1355504-1

Details and patient eligibility

About

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.

Enrollment

15 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

15 participants in 2 patient groups, including a placebo group

Grains of Paradise
Experimental group
Treatment:
Dietary Supplement: Grains of Paradise (Aframomum Melegueta)
Placebo
Placebo Comparator group
Treatment:
Dietary Supplement: Grains of Paradise (Aframomum Melegueta)

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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