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

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

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.

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

Conditions
-----------------
Body Weight Changes

Intervention / Treatment
-----------------
* Drug: L-Carnitine
* Dietary Supplement: Sucralose


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Sucralose 1,5 g | Dietary Supplement: Sucralose<br>* Sucralose 1.5 g diluted in 250 ml of water, before crossfit training, 5 times a week for 8 weeks<br>* Other names: Trichlorogalacto-sucrose;|
| Experimental: L-Carnitine<br>L- Carnitine 1,5 g | Drug: L-Carnitine<br>* L-Carnitine oral solution 1.5 g diluted in 250 ml of water, before crossfit training, 5 times a week for 8 weeks<br>* Other names: Vitamin BT;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Fat | Calulated by Durnin formula. Results are reported in percentage and kg | 8 weeks | 
| Lean body mass | Calulated by Durnin formula. Results are reported in percentage and kg | 8 weeks | 
| Body Weight | 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 | 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 | 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 | Body mass divided by the square of the body height, and reported in units of kg/m2. | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Overweight, Obesity, L-Carnitine, Body weight, Body fat percentage