Body Weight ChangesPhase 2NCT03436277
Effect of the Administration of L-Carnitine on Body Weight in Women in Crossfit Training
A Phase 2 study testing L-Carnitine and Sucralose in people with Body Weight Changes, run by University of Guadalajara at 1 site in Mexico.
Trial summary
The L-carnitine has demonstrated effects in the treatment of obesity mainly promoting the fat degradation during exercise. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Body Weight Changes
- What is being tested?
- L-Carnitine and Sucralose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteMexico
- Study dates
- 17 Dec 2018to May 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of the Administration of L-Carnitine on Body Fat Percentage and Body Weight in Overweight Women in Crossfit Training.
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.
- Conditions
- Body Weight Changes
- Being tested
- L-Carnitine, Sucralose
- Keywords
- Overweight, Obesity, L-Carnitine, Body weight, Body fat percentage
- Medical subject headings
- Body Weight Changes, Overweight, Obesity, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-CarnitineDrug
Also called Levocarnitine, Vitamin BT
L-Carnitine oral solution 1.5 g diluted in 250 ml of water, before crossfit training, 5 times a week for 8 weeks
SucraloseDietary supplement
Also called Trichlorogalacto-sucrose
Sucralose 1.5 g diluted in 250 ml of water, before crossfit training, 5 times a week for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Sucralose 1,5 g Receives: Dietary Supplement: Sucralose |
| L-Carnitine | Experimental | L- Carnitine 1,5 g Receives: Drug: L-Carnitine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Fat
Calulated by Durnin formula. Results are reported in percentage and kg
Measured: 8 weeks
Lean body mass
Calulated by Durnin formula. Results are reported in percentage and kg
Measured: 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.
Measured: 8 weeks
Secondary outcomes (3)
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
Measured: 8 weeks
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.
Measured: 8 weeks
Body Mass Index
Body mass divided by the square of the body height, and reported in units of kg/m2.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start17 Dec 2018 (estimated)
- Primary completionFeb 2019 (estimated)
- Study completionMay 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Body Weight ChangesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Guadalajara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diana Mercedes Hernández Corona, University of Guadalajara
- Investigators
- Diana M Hernández, Principal investigator, University of Guadalajara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03436277
- Sponsor's protocol ID
- LC-CUT-DMHC
- Status last verified
- Feb 2018
- First submitted
- 11 Feb 2018
- Last updated
- 20 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 23075564Villani 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 10861338Hongu 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 12514272Broad 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 21813919Behrend 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 22030098Kraemer 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.
PubMed 16826026
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Administration of L-Carnitine on Body Fat Percentage and Body Weight in Overweight Women in Crossfit Training.
- ClinicalTrials.gov ID
- NCT03436277
- Acronym / sponsor ID
- LC-CUT-DMHC
- Conditions
- Body Weight Changes
- Keywords
- Overweight, Obesity, L-Carnitine, Body weight, Body fat percentage
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of GuadalajaraUniversity, hospital or other
- Study start
- 17 Dec 2018 (estimated)
- Primary completion
- Feb 2019 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 19 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: SucraloseSucralose 1,5 g |
| L-Carnitine | Experimental | Drug: L-CarnitineL- Carnitine 1,5 g |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L-CarnitineAlso: Levocarnitine, Vitamin BTL-Carnitine oral solution 1.5 g diluted in 250 ml of water, before crossfit training, 5 times a week for 8 weeks | Drug | L-Carnitine |
| SucraloseAlso: Trichlorogalacto-sucroseSucralose 1.5 g diluted in 250 ml of water, before crossfit training, 5 times a week for 8 weeks | Dietary supplement | Placebo |
Primary outcome
Body Fat
Time frame: 8 weeks
Calulated by Durnin formula. Results are reported in percentage and kg
Lean body mass
Time frame: 8 weeks
Calulated by Durnin formula. Results are reported in percentage and kg
Body Weight
Time frame: 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.
3 secondary outcomes
Arm muscle circumference
Time frame: 8 weeks
Waist circumference
Time frame: 8 weeks
Body Mass Index
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2018.
- Background: PubMed 23075564Huang 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.
- Background: PubMed 10861338Villani 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.
- Background: PubMed 12514272Hongu 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.
- Background: PubMed 21813919Broad 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.
- Background: PubMed 22030098Behrend 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.
- Background: PubMed 16826026Kraemer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diana M Hernández principal investigator
University of Guadalajara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing L-Carnitine and Sucralose in people with Body Weight Changes, run by University of Guadalajara at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Diana M Hernández, PhD (+521 3314856584, diana.hcorona@academicos.udg.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Fat (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03436277, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2018.