Clinical trial NCT03436277: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Body Weight Changes
Keywords: Overweight
Obesity
L-Carnitine
Body weight
Body fat percentage
Lead sponsor: University of Guadalajara
Sponsor class: OTHER
First posted: 2018-02-19
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Body Fat
timeFrame: 8 weeks
measure: Lean body mass
timeFrame: 8 weeks
measure: Body Weight
timeFrame: 8 weeks
Secondary outcomes:
measure: Arm muscle circumference
timeFrame: 8 weeks
measure: Waist circumference
timeFrame: 8 weeks
measure: Body Mass Index
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Tonalá
country: Mexico
facility: Centro Universitario de Tonalá
state: Jalisco
Study officials:
affiliation: University of Guadalajara
name: Diana M Hernández
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.