The Acute Metabolic Impacts of Kaempferia Parviflora Extract in Healthy Men: a Randomized Double Blind Proof of Concept Study
Phase: NA
Conditions: No Disease or Condition is Being Studied, Metabolism
Sponsor: Nova Southeastern University

Title: The Acute Metabolic Impacts of Kampferia parviflora extract in Healthy Men: A 
Randomized Double-Blind Proof of Concept Study 
 
January 28, 2025 
 
NCT:  
 
 

 
Study Protocol 
 
Study Design 
This study followed a randomized, double-blinded, crossover design. Participants reported to the 
clinical site on two separate visits. Participants were instructed to abstain from exercise on 
testing day and arrive at the lab fasted (no food or caffeine ingestion for 4 hours prior). Testing 
sessions consisted of two visits per week with      a minimum of 24 hours between visits.     
During the first visit demographics and anthropometrics were assessed. At every testing each 
subject      completed the following protocol:      baseline Metabolic Rate and Respiratory 
Quotient. Immediately after baseline test, participants consumed supplement 1 or 2. Metabolic 
Rate and Respiratory Quotient Testing was repeated at 60, 120, and 180 minutes after 
supplementation. All participants underwent an informed consent process in accordance with the 
Declaration of Helsinki and an approved IRB protocol approved by     institutional review board 
at Nova Southeastern University, IRB number 2024-209. 
 
 
Metabolic and Respiratory Quotient Testing 
An indirect calorimetry device (Parvo Medics TrueOne 2400) was used to measure RMR and 
RQ. The device was calibrated according to the manufacturer’s instructions. Participants were 
instructed to lay completely still and relax for 15 minutes. The first 5 minutes was allotted for 
acclimatization. The Parvo Metabolic Cart measures the volume of oxygen consumed (VO₂) and 
the volume of carbon dioxide produced (VCO₂) by the patient on a breath-by-breath basis. The 
ratio of these gases is used to determine the Respiratory Quotient (RQ), providing information 
regarding substrate utilization. The parameters that were measured and used for analysis were 
RMR, O2 volume (VO2), CO2 volume (VCO2), the RQ, percentage of utilized fat (Fat%), and 
percentage of utilized carbohydrates (CHO%). 
 
 
Statistical Analysis 
 
All data is expressed as mean SD. Basic descriptive statistics were used for participant 
demographics and anthropometrics. A paired t-test was used to assess any differences between 
the 100 and 200 mg doses for REE and RER at baseline. To determine the effects of 
Gyngerlean™ on energy expenditure, a repeated-measures analysis of variance (ANOVA) was 
used to determine differences between 100mg and 200mg doses for the 60, 120- and 180-time 
intervals. A repeated Dunnett's multiple