No Disease or Condition is Being StudiedNCT06805201
The Effects of Gyngerlean Supplementation on Energy Expenditure
A study testing Gyngerlean in people with No Disease or Condition is Being Studied and Metabolism, run by Nova Southeastern University at 1 site in United States.
Trial summary
The goal of this randomized controlled study is to asses the effects of a ginger containing supplement on energy expenditure and substrate utilization in healthy men. The main questions it aims to answer are" The effects of Kaempferia parviflora extract on energy expenditure The effects of Kaempferia parviflora… Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- No Disease or Condition is Being Studied, Metabolism
- What is being tested?
- Gyngerlean
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jul 2024to 8 Aug 2024
- 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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Active adults. Active is defined as exercising 3 or more times a week for 30 minutes.
Who cannot join
- Participants must not be diabetics, have Celiac disease, or individuals with pre-existing heart or kidney disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Acute Metabolic Impacts of Kaempferia Parviflora Extract in Healthy Men: a Randomized Double Blind Proof of Concept Study
The goal of this randomized controlled study is to asses the effects of a ginger containing supplement on energy expenditure and substrate utilization in healthy men. The main questions it aims to answer are"
- The effects of Kaempferia parviflora extract on energy expenditure
- The effects of Kaempferia parviflora extract on substrate utilization
- Being tested
- Gyngerlean
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GyngerleanDietary supplement
Alpinia galangal (Red Ginger), Kaempferia parviflora (Black Ginger), and Zingiber officinale (Yellow Ginger).
| Study group | Role | What they receive |
|---|---|---|
| Supplement 1 | Experimental | GyngerLean™ 100 mg Receives: Dietary Supplement: Gyngerlean |
| Supplement 2 | Experimental | GyngerLean™ 200 mg Receives: Dietary Supplement: Gyngerlean |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resting Metabolic rate
The amount of energy/calories the body needs to function while at rest.
Measured: 180 minutes
Secondary outcomes (1)
Respiratory quotient
The ratio between carbon dioxide production and oxygen consumption.
Measured: 180 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study start23 Jul 2024
- Primary completion8 Aug 2024
- Study completion8 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for No Disease or Condition is Being StudiedStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Southeastern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cassandra Evans, Nova Southeastern University
- Investigators
- Lia Jiannine, Principal investigator, ljiannine@nova.edu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06805201
- Sponsor's protocol ID
- IRB 2024-319
- Status last verified
- Jan 2025
- First submitted
- 21 Jan 2025
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute Metabolic Impacts of Kaempferia Parviflora Extract in Healthy Men: a Randomized Double Blind Proof of Concept Study
- ClinicalTrials.gov ID
- NCT06805201
- Acronym / sponsor ID
- IRB 2024-319
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Nova Southeastern UniversityUniversity, hospital or other
- Study start
- 23 Jul 2024 (actual)
- Primary completion
- 8 Aug 2024 (actual)
- Study completion
- 8 Aug 2024 (actual)
- First posted
- 3 Feb 2025 (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.
The goal of this randomized controlled study is to asses the effects of a ginger containing supplement on energy expenditure and substrate utilization in healthy men. The main questions it aims to answer are"
- The effects of Kaempferia parviflora extract on energy expenditure
- The effects of Kaempferia parviflora extract on substrate utilization
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supplement 1 | Experimental | Dietary Supplement: GyngerleanGyngerLean™ 100 mg |
| Supplement 2 | Experimental | Dietary Supplement: GyngerleanGyngerLean™ 200 mg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Active adults. Active is defined as exercising 3 or more times a week for 30 minutes.
Key exclusion criteria (1 listed)
- Participants must not be diabetics, have Celiac disease, or individuals with pre-existing heart or kidney disease.
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 |
|---|---|---|
| GyngerleanAlpinia galangal (Red Ginger), Kaempferia parviflora (Black Ginger), and Zingiber officinale (Yellow Ginger). | Dietary supplement | Supplement 1, Supplement 2 |
Primary outcome
Resting Metabolic rate
Time frame: 180 minutes
The amount of energy/calories the body needs to function while at rest.
1 secondary outcome
Respiratory quotient
Time frame: 180 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
- Individual participant dataSharing planned: No
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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.
Lia Jiannine principal investigator
ljiannine@nova.edu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gyngerlean in people with No Disease or Condition is Being Studied and Metabolism, run by Nova Southeastern University at 1 site in United States.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (time frame: 180 minutes). 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 3 Feb 2025.