ClinicalTrials.gg
Status unknownNCT03436277Updated Feb 20, 2018

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

A Phase 2 interventional study of L-Carnitine and Sucralose in Body Weight Changes, sponsored by University of Guadalajara. Status unknown at 1 site in Mexico. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-20.

Sponsored by University of Guadalajara · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study summary

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

Read the 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.

02

Conditions studied

  • Body Weight Changes

Keywords

  • Overweight
  • Obesity
  • L-Carnitine
  • Body weight
  • Body fat percentage
03

In context

Body Weight Changes

231 studies on the registry are indexed under Body Weight Changes; 30 are open to participants now.

This study's planned enrollment of 24 is below the median of 80 across 179 interventional studies indexed under Body Weight Changes.

Browse Body Weight Changes studies →

Lead sponsor

University of Guadalajara is the lead sponsor of 95 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Volunteers who practice crossfit regularly (who have 3 months prior to the beginning of the study practicing crossfit).
  • Volunteers with a equal to or greater than 25 Kg/m2.
  • Volunteers who do not have allergies to L-Carnitine or any of its components.
  • 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

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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
24 participants (estimated)

Study arms

  • Placebo comparator
    Placebo

    Sucralose 1,5 g

    Dietary Supplement: Sucralose

  • Experimental
    L-Carnitine

    L- Carnitine 1,5 g

    Drug: L-Carnitine

Interventions

  • L-Carnitine oral solution 1.5 g diluted in 250 ml of water, before crossfit training, 5 times a week for 8 weeks

    Also known as: Levocarnitine, Vitamin BT

  • Dietary supplementSucralose

    Sucralose 1.5 g diluted in 250 ml of water, before crossfit training, 5 times a week for 8 weeks

    Also known as: Trichlorogalacto-sucrose

06

What researchers measure

Primary outcomes

  1. Body Fat

    Calulated by Durnin formula. Results are reported in percentage and kg

    Time frame: 8 weeks

  2. Lean body mass

    Calulated by Durnin formula. Results are reported in percentage and kg

    Time frame: 8 weeks

  3. 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.

    Time frame: 8 weeks

Secondary outcomes

  1. 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

    Time frame: 8 weeks

  2. 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.

    Time frame: 8 weeks

  3. Body Mass Index

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

    Time frame: 8 weeks

07

Study locations

1 site
  • Centro Universitario de Tonalá
    Tonalá, Jalisco 45425, Mexico
08

References and documents

Publications

  • 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. PubMed 23075564 ↗
  • 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. PubMed 10861338 ↗
  • 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. PubMed 12514272 ↗
  • 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. PubMed 21813919 ↗
  • 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. PubMed 22030098 ↗
  • 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. PubMed 16826026 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Dec 2018; primary completion for Feb 2019, 2 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 11, 2018
First posted
Feb 19, 2018
StartEst.
Dec 17, 2018
Primary completionEst.
Feb 2019
CompletionEst.
May 2019
Last update
Feb 20, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 20, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03436277
Lead sponsor
University of Guadalajara
Responsible party
Diana Mercedes Hernández Corona (PhD of Pharmacology, University of Guadalajara) — Principal investigator
First posted
Feb 19, 2018
Start date
Dec 17, 2018 (estimated)
Primary completion
Feb 2019 (estimated)
Completion
May 2019 (estimated)
Last update
Feb 20, 2018

Study contacts

Diana M Hernández, PhD
Contact
diana.hcorona@academicos.udg.mx
+521 3314856584
Tonatiuh González, PhD
Contact
drtonatiuhgh@live.com.mx
+521 3314664863
Diana M Hernández
principal investigator · University of Guadalajara

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Carnitine

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