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

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ClinicalTrials.gov Identifier: NCT03436277
Recruitment Status : Not yet recruiting
First Posted : February 16, 2018
Last Update Posted : February 20, 2018
Sponsor:
Information provided by (Responsible Party):
Diana Mercedes Hernández Corona, University of Guadalajara

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

Condition or disease Intervention/treatment Phase
Body Weight Changes Drug: L-Carnitine Dietary Supplement: Sucralose Phase 2

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  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of the Administration of L-Carnitine on Body Fat Percentage and Body Weight in Overweight Women in Crossfit Training.
Estimated Study Start Date : December 17, 2018
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight
U.S. FDA Resources

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 Name: 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



Primary Outcome Measures :
  1. Body Fat [ Time Frame: 8 weeks ]
    Calulated by Durnin formula. Results are reported in percentage and kg

  2. Lean body mass [ Time Frame: 8 weeks ]
    Calulated by Durnin formula. Results are reported in percentage and kg

  3. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.


  3. Body Mass Index [ Time Frame: 8 weeks ]
    Body mass divided by the square of the body height, and reported in units of kg/m2.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03436277


Contacts
Contact: Diana M Hernández, PhD +521 3314856584 diana.hcorona@academicos.udg.mx
Contact: Tonatiuh González, PhD +521 3314664863 drtonatiuhgh@live.com.mx

Locations
Mexico
Centro Universitario de Tonalá Enrolling by invitation
Tonalá, Jalisco, Mexico, 45425
Sponsors and Collaborators
University of Guadalajara
Investigators
Principal Investigator: Diana M Hernández University of Guadalajara

Publications:
Responsible Party: Diana Mercedes Hernández Corona, PhD of Pharmacology, University of Guadalajara
ClinicalTrials.gov Identifier: NCT03436277     History of Changes
Other Study ID Numbers: LC-CUT-DMHC
First Posted: February 16, 2018    Key Record Dates
Last Update Posted: February 20, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Diana Mercedes Hernández Corona, University of Guadalajara:
Overweight
Obesity
L-Carnitine
Body weight
Body fat percentage

Additional relevant MeSH terms:
Body Weight
Body Weight Changes
Signs and Symptoms