NCT06805201

Brief 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 extract on substrate utilization

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 23, 2024

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 8, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 8, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 3, 2025

Completed
Last Updated

February 3, 2025

Status Verified

January 1, 2025

Enrollment Period

16 days

First QC Date

January 21, 2025

Last Update Submit

January 29, 2025

Conditions

No Disease or Condition is Being StudiedMetabolism

Outcome Measures

Primary Outcomes (1)

  • Resting Metabolic rate

    The amount of energy/calories the body needs to function while at rest.

    180 minutes

Secondary Outcomes (1)

  • Respiratory quotient

    180 minutes

Study Arms (2)

Supplement 1

EXPERIMENTAL

GyngerLean™ 100 mg

Dietary Supplement: Gyngerlean

Supplement 2

EXPERIMENTAL

GyngerLean™ 200 mg

Dietary Supplement: Gyngerlean

Interventions

GyngerleanDIETARY_SUPPLEMENT

Alpinia galangal (Red Ginger), Kaempferia parviflora (Black Ginger), and Zingiber officinale (Yellow Ginger).

Supplement 1Supplement 2

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nova Southeastern University

Davie, Florida, 333328, United States

Location

Study Officials

  • Lia Jiannine

    ljiannine@nova.edu

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
co-investigator

Study Record Dates

First Submitted

January 21, 2025

First Posted

February 3, 2025

Study Start

July 23, 2024

Primary Completion

August 8, 2024

Study Completion

August 8, 2024

Last Updated

February 3, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)