Effect of the Administration of L-Carnitine on Body Weight in Women in Crossfit Training

February 18, 2018 updated by: Diana Mercedes Hernández Corona, University of Guadalajara

Effect of the Administration of L-Carnitine on Body Fat Percentage and Body Weight in Overweight Women in Crossfit Training.

The L-carnitine has demonstrated effects in the treatment of obesity mainly promoting the fat degradation during exercise.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

A randomized, double-blind, placebo-controlled clinical trial will be carry out in 24 woman with body mass index ≥ 25 to 29.9 kg/m2. The patients will receive 1.5 g of L-Carnitine deluded in 250 ml of water or placebo before crossfit training, 5 times a week for 8 weeks. Before and after intervention the investigators evaluate: The body composition (body fat, lean body mass), arm muscle circumference, waist circumference, body weight and body mass index.

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Phase 2

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • Mexico
    • Jalisco
      • Tonalá, Jalisco, Mexico, 45425
        • Centro Universitario de Tonalá

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

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Volunteers who practice crossfit regularly (who have 3 months prior to the beginning of the study practicing crossfit).
  • Volunteers with a body mass index equal to or greater than 25 Kg/m2.
  • Volunteers who do not have allergies to L-Carnitine or any of its components.
  • Informed consent signed
  • Women with a recommendation of nutrition two weeks prior to the start of the study.
  • Body weight stable the last 3 months.

Exclusion Criteria:

  • Volunteers with pathologies such as diabetes, hypertension, metabolic syndrome and allergies.
  • Women with confirmed or suspected pregnancy.
  • Women under lactation and/or puerperium.
  • Hypersensibilility to L-Carnitine or Sucralose.
  • Kown of renal, hepatic or thyroid deseased.
  • Current or previous treatment diet (3 months before inclusion to the study).
  • Current pharmacological treatment for loose body weight or 3 months before inclusion to the study.

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Sucralose 1,5 g
Dietary supplement: Sucralose
Sucralose 1.5 g diluted in 250 ml of water, before crossfit training, 5 times a week for 8 weeks
Other Names:
  • Trichlorogalacto-sucrose
Experimental: L-Carnitine
L- Carnitine 1,5 g
Drug: L-Carnitine
L-Carnitine oral solution 1.5 g diluted in 250 ml of water, before crossfit training, 5 times a week for 8 weeks
Other Names:
  • Levocarnitine
  • Vitamin BT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body Fat
Time Frame: 8 weeks
Calulated by Durnin formula. Results are reported in percentage and kg
8 weeks
Lean body mass
Time Frame: 8 weeks
Calulated by Durnin formula. Results are reported in percentage and kg
8 weeks
Body Weight
Time Frame: 8 weeks
Subject go up onto the scale and stand still over the center of the scale with body weight evenly distributed between both feet. Omron hbf-514c an digital scale and results are reported in kg with a decimal.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Arm muscle circumference
Time Frame: 8 weeks
The right arm measure to the nearest centimeter with a measuring tape. Then, triceps skinfold thickness, an established measure of fat stores, measure to the nearest millimeter in the right arm using a skinfold caliper
8 weeks
Waist circumference
Time Frame: 8 weeks

Flexible tape in the midpoint between the lowest rib and the iliac crest and is expressed in centimeters.

Waist circumference was measured with a flexible tape in the midpoint between the lowest rib and the iliac crest and is expressed in centimeters.

Waist circumference was measured with a flexible tape in the midpoint between the lowest rib and the iliac crest and is expressed in centimeters.
8 weeks
Body Mass Index
Time Frame: 8 weeks
Body mass divided by the square of the body height, and reported in units of kg/m2.
8 weeks

Collaborators and Investigators

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

Sponsor

University of Guadalajara

Investigators

  • Principal Investigator: Diana M Hernández, University of Guadalajara

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Anticipated)

December 17, 2018

Primary Completion (Anticipated)

February 1, 2019

Study Completion (Anticipated)

May 1, 2019

Study Registration Dates

First Submitted

February 11, 2018

First Submitted That Met QC Criteria

February 11, 2018

First Posted (Actual)

February 19, 2018

Study Record Updates

Last Update Posted (Actual)

February 20, 2018

Last Update Submitted That Met QC Criteria

February 18, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LC-CUT-DMHC

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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