ObesityNCT03894137
The Acute Effect of Grains of Paradise (Aframomum Melegueta) on REE
A study testing Grains of Paradise (Aframomum Melegueta) in people with Obesity, run by Plexus Worldwide.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Grains of Paradise (Aframomum Melegueta)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Oct 2019to May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
About this study
Official title: 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.
- Conditions
- Obesity
- Being tested
- Grains of Paradise (Aframomum Melegueta)
- Keywords
- Grains of Paradise, energy metabolism, substrate oxidation
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Grains of Paradise | Experimental | Not described Receives: Dietary Supplement: Grains of Paradise (Aframomum Melegueta) |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Grains of Paradise (Aframomum Melegueta) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resting metabolic Rate (Liters of oxygen consumed per minute)
Metabolic cart (metabolic gas exchange, indirect calorimitry)
Measured: 3 weeks
Secondary outcomes (1)
Resting substrate oxidation
Metabolic cart (respiratory exchange ratio)
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2019
- Study startOct 2019 (estimated)
- Primary completionMar 2020 (estimated)
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Plexus Worldwide
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- George Mason University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03894137
- Sponsor's protocol ID
- 1355504-1
- Status last verified
- Mar 2019
- First submitted
- 25 Mar 2019
- Last updated
- 28 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute Effect of Grains of Paradise (Aframomum Melegueta) on Resting Energy Expenditure in Lean, Healthy, Adults
- ClinicalTrials.gov ID
- NCT03894137
- Acronym / sponsor ID
- 1355504-1
- Conditions
- Obesity
- Keywords
- Grains of Paradise, energy metabolism, substrate oxidation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Plexus WorldwideIndustry (pharma, biotech, devices)
- Collaborators
- George Mason University
- Study start
- Oct 2019 (estimated)
- Primary completion
- Mar 2020 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 28 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Grains of Paradise | Experimental | Dietary Supplement: Grains of Paradise (Aframomum Melegueta) |
| Placebo | Placebo comparator | Dietary Supplement: Grains of Paradise (Aframomum Melegueta) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Grains of Paradise (Aframomum Melegueta)This is a randomized, double blind, crossover design testing the effect of grains of paradise on resting energy metabolism | Dietary supplement | Grains of Paradise, Placebo |
Primary outcome
Resting metabolic Rate (Liters of oxygen consumed per minute)
Time frame: 3 weeks
Metabolic cart (metabolic gas exchange, indirect calorimitry)
1 secondary outcome
Resting substrate oxidation
Time frame: 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Grains of Paradise (Aframomum Melegueta) in people with Obesity, run by Plexus Worldwide.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resting metabolic Rate (Liters of oxygen consumed per minute) (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2019.