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

Primary Purpose

Body Weight Changes

Status
Unknown status
Phase
Phase 2
Locations
Mexico
Study Type
Interventional
Intervention
L-Carnitine
Sucralose
Sponsored by
University of Guadalajara
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Body Weight Changes focused on measuring Overweight, Obesity, L-Carnitine, Body weight, Body fat percentage

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Centro Universitario de Tonalá

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

L-Carnitine

Arm Description

Sucralose 1,5 g

L- Carnitine 1,5 g

Outcomes

Primary Outcome Measures

Body Fat
Calulated by Durnin formula. Results are reported in percentage and kg
Lean body mass
Calulated by Durnin formula. Results are reported in percentage and kg
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.

Secondary Outcome Measures

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
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.
Body Mass Index
Body mass divided by the square of the body height, and reported in units of kg/m2.

Full Information

First Posted
February 11, 2018
Last Updated
February 18, 2018
Sponsor
University of Guadalajara
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1. Study Identification

Unique Protocol Identification Number
NCT03436277
Brief Title
Effect of the Administration of L-Carnitine on Body Weight in Women in Crossfit Training
Official Title
Effect of the Administration of L-Carnitine on Body Fat Percentage and Body Weight in Overweight Women in Crossfit Training.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 17, 2018 (Anticipated)
Primary Completion Date
February 2019 (Anticipated)
Study Completion Date
May 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Guadalajara

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Weight Changes
Keywords
Overweight, Obesity, L-Carnitine, Body weight, Body fat percentage

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Sucralose 1,5 g
Arm Title
L-Carnitine
Arm Type
Experimental
Arm Description
L- Carnitine 1,5 g
Intervention Type
Drug
Intervention Name(s)
L-Carnitine
Other Intervention Name(s)
Levocarnitine, Vitamin BT
Intervention Description
L-Carnitine oral solution 1.5 g diluted in 250 ml of water, before crossfit training, 5 times a week for 8 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Sucralose
Other Intervention Name(s)
Trichlorogalacto-sucrose
Intervention Description
Sucralose 1.5 g diluted in 250 ml of water, before crossfit training, 5 times a week for 8 weeks
Primary Outcome Measure Information:
Title
Body Fat
Description
Calulated by Durnin formula. Results are reported in percentage and kg
Time Frame
8 weeks
Title
Lean body mass
Description
Calulated by Durnin formula. Results are reported in percentage and kg
Time Frame
8 weeks
Title
Body Weight
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Arm muscle circumference
Description
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
Time Frame
8 weeks
Title
Waist circumference
Description
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.
Time Frame
8 weeks
Title
Body Mass Index
Description
Body mass divided by the square of the body height, and reported in units of kg/m2.
Time Frame
8 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Diana M Hernández, PhD
Phone
+521 3314856584
Email
diana.hcorona@academicos.udg.mx
First Name & Middle Initial & Last Name or Official Title & Degree
Tonatiuh González, PhD
Phone
+521 3314664863
Email
drtonatiuhgh@live.com.mx
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diana M Hernández
Organizational Affiliation
University of Guadalajara
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro Universitario de Tonalá
City
Tonalá
State/Province
Jalisco
ZIP/Postal Code
45425
Country
Mexico

12. IPD Sharing Statement

Citations:
PubMed Identifier
23075564
Citation
Huang A, Owen K. Role of supplementary L-carnitine in exercise and exercise recovery. Med Sport Sci. 2012;59:135-142. doi: 10.1159/000341934. Epub 2012 Oct 15.
Results Reference
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PubMed Identifier
10861338
Citation
Villani RG, Gannon J, Self M, Rich PA. L-Carnitine supplementation combined with aerobic training does not promote weight loss in moderately obese women. Int J Sport Nutr Exerc Metab. 2000 Jun;10(2):199-207. doi: 10.1123/ijsnem.10.2.199.
Results Reference
background
PubMed Identifier
12514272
Citation
Hongu N, Sachan DS. Carnitine and choline supplementation with exercise alter carnitine profiles, biochemical markers of fat metabolism and serum leptin concentration in healthy women. J Nutr. 2003 Jan;133(1):84-9. doi: 10.1093/jn/133.1.84.
Results Reference
background
PubMed Identifier
21813919
Citation
Broad EM, Maughan RJ, Galloway S DR. Effects of exercise intensity and altered substrate availability on cardiovascular and metabolic responses to exercise after oral carnitine supplementation in athletes. Int J Sport Nutr Exerc Metab. 2011 Oct;21(5):385-97. doi: 10.1123/ijsnem.21.5.385. Epub 2011 Aug 3.
Results Reference
background
PubMed Identifier
22030098
Citation
Behrend AM, Harding CO, Shoemaker JD, Matern D, Sahn DJ, Elliot DL, Gillingham MB. Substrate oxidation and cardiac performance during exercise in disorders of long chain fatty acid oxidation. Mol Genet Metab. 2012 Jan;105(1):110-5. doi: 10.1016/j.ymgme.2011.09.030. Epub 2011 Oct 1.
Results Reference
background
PubMed Identifier
16826026
Citation
Kraemer WJ, Spiering BA, Volek JS, Ratamess NA, Sharman MJ, Rubin MR, French DN, Silvestre R, Hatfield DL, Van Heest JL, Vingren JL, Judelson DA, Deschenes MR, Maresh CM. Androgenic responses to resistance exercise: effects of feeding and L-carnitine. Med Sci Sports Exerc. 2006 Jul;38(7):1288-96. doi: 10.1249/01.mss.0000227314.85728.35. Erratum In: Med Sci Sports Exerc. 2006 Oct;38(10):1861.
Results Reference
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Effect of the Administration of L-Carnitine on Body Weight in Women in Crossfit Training

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