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

Phase 2

• Conditions: Body Weight Changes
• Interventions: Dietary Supplement: Sucralose; Drug: L-Carnitine

• Registration Number: NCT03436277
• Lead Sponsor: University of Guadalajara

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.

Study Timeline

• Status Verified: 2018-02
• Study First Submitted: 2018-02-11
• Study First Submitted QC: 2018-02-11
• Last Update Submitted: 2018-02-18
• Study First Posted: 2018-02-19
• Last Update Posted: 2018-02-20
• Study Start: 2018-12-17
• Primary Completion: 2019-02
• Study Completion: 2019-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Sucralose	Sucralose 1,5 g
L-Carnitine	L-Carnitine	L- Carnitine 1,5 g

Primary Outcome Measures

Name	Time	Method
Body Fat	8 weeks	Calulated by Durnin formula. Results are reported in percentage and kg
Body Weight	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.
Lean body mass	8 weeks	Calulated by Durnin formula. Results are reported in percentage and kg

Secondary Outcome Measures

Name	Time	Method
Body Mass Index	8 weeks	Body mass divided by the square of the body height, and reported in units of kg/m2.
Arm muscle circumference	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
Waist circumference	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.

Trial Locations

Locations (1)

Centro Universitario de Tonalá; 🇲🇽 Tonalá, Jalisco, Mexico