The Effects of Gyngerlean Supplementation on Energy Expenditure

January 29, 2025 updated by: Cassandra Evans, Nova Southeastern University

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Davie, Florida, United States, 333328
        • Nova Southeastern University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Active adults. Active is defined as exercising 3 or more times a week for 30 minutes.

Exclusion Criteria:

  • Participants must not be diabetics, have Celiac disease, or individuals with pre-existing heart or kidney disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Supplement 1
GyngerLean™ 100 mg
Dietary supplement: Gyngerlean
Alpinia galangal (Red Ginger), Kaempferia parviflora (Black Ginger), and Zingiber officinale (Yellow Ginger).
Experimental: Supplement 2
GyngerLean™ 200 mg
Dietary supplement: Gyngerlean
Alpinia galangal (Red Ginger), Kaempferia parviflora (Black Ginger), and Zingiber officinale (Yellow Ginger).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resting Metabolic rate
Time Frame: 180 minutes
The amount of energy/calories the body needs to function while at rest.
180 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Respiratory quotient
Time Frame: 180 minutes
The ratio between carbon dioxide production and oxygen consumption.
180 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nova Southeastern University

Investigators

  • Principal Investigator: Lia Jiannine, ljiannine@nova.edu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 23, 2024

Primary Completion (Actual)

August 8, 2024

Study Completion (Actual)

August 8, 2024

Study Registration Dates

First Submitted

January 21, 2025

First Submitted That Met QC Criteria

January 29, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 29, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • IRB 2024-319

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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