NCT03436277

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2018

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 19, 2018

Completed
10 months until next milestone

Study Start

First participant enrolled

December 17, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

February 20, 2018

Status Verified

February 1, 2018

Enrollment Period

2 months

First QC Date

February 11, 2018

Last Update Submit

February 18, 2018

Conditions

Keywords

OverweightObesityL-CarnitineBody weightBody fat percentage

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (3)

  • Arm muscle circumference

    8 weeks

  • Waist circumference

    8 weeks

  • Body Mass Index

    8 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Sucralose 1,5 g

Dietary Supplement: Sucralose

L-Carnitine

EXPERIMENTAL

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
L-Carnitine
SucraloseDIETARY_SUPPLEMENT

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
Placebo

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro Universitario de Tonalá

Tonalá, Jalisco, 45425, Mexico

Location

Related Publications (6)

  • 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.

    PMID: 23075564BACKGROUND
  • 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.

    PMID: 10861338BACKGROUND
  • 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.

    PMID: 12514272BACKGROUND
  • 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.

    PMID: 21813919BACKGROUND
  • 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.

    PMID: 22030098BACKGROUND
  • 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.

    PMID: 16826026BACKGROUND

MeSH Terms

Conditions

Body Weight ChangesOverweightObesityBody Weight

Interventions

Carnitinetrichlorosucrose

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsOvernutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Trimethyl Ammonium CompoundsQuaternary Ammonium CompoundsAminesOrganic Chemicals

Study Officials

  • Diana M Hernández

    University of Guadalajara

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tonatiuh González, PhD

CONTACT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD of Pharmacology

Study Record Dates

First Submitted

February 11, 2018

First Posted

February 19, 2018

Study Start

December 17, 2018

Primary Completion

February 1, 2019

Study Completion

May 1, 2019

Last Updated

February 20, 2018

Record last verified: 2018-02

Locations