- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02533479
Erythrocytes and Skeletal-muscle Fatty Acids Are Positively Correlated After Caloric Restriction and Exercise
August 25, 2015 updated by: FRANCISCO DROBNIC, MD, PhD, Centre d'Alt Rendiment
Erythrocytes and Skeletal-muscle Unsaturated and Omega-6 Fatty Acids Are Positively Correlated After Caloric Restriction and Exercise
The aim is compare and correlate skeletal muscle and erythrocytes fatty acids (FAs) profiles in adult healthy human after caloric restriction and acute exercise in order to validate erythrocyte FAs profile as marker of changes in muscle fatty acid composition.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The study was performed with 11 healthy sportsmen participating in a caloric restriction trial for 1 month.
The participants follow a caloric restriction, 30-40% respect to the usual diet of each participant, three alternate days weekly along 4 weeks.
After the caloric restriction period the participants realized an exercise stress test.
For each participant one blood sample and muscular biopsy were obtained after acute exercise and caloric restriction intervention.
All the participants were informed of the purpose and demands of the study before giving their written consent to participate.
The study protocol was in accordance with the Declaration of Helsinki for research on human participants and was approved by the local Ethics Committee of the Consell Català de l'Esport.
Study Type
Interventional
Enrollment (Actual)
11
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Barcelona, Spain, 08174
- Centre D'Alt Rendinemt, Sant Cugat
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- age (18-50 years old),
- sex (male),
- equilibrate diet and physical activity of 3 days weekly.
Exclusion Criteria:
- sex (female),
- smokers.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Caloric restriction
three alternate days weekly along 4 weeks.
|
three alternate days weekly along 4 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in skeletal muscle FAs profiles in adult healthy human after caloric restriction and acute exercise
Time Frame: 8 weeks
|
Muscular biopsy was obtained from vastus lateralis of the quadricipitalis muscle.
The dermis was cut for to display muscular aponeurosis (<2.5 cm) after clean and sterilize the biopsy zone.
Next the aponeurosis was cut and a puncture with Vacora® device (Bard Biopsy Systems, Tempe, AZ, USA) was realized.
The injury was cleaned and sutured, and the muscular sample was stored at -80ºC until FA analyses..FA composition of skeletal muscle were determined by gas chromatography.
|
8 weeks
|
Changes in erythrocytes FAs profiles in adult healthy human after caloric restriction and acute exercise
Time Frame: 8 weeks
|
Venous blood samples were obtained from the antecubital vein of participants with vacutainers containing EDTA (ethylenediaminetetraacetic acid) as anticoagulant (6 mL) to purify erythrocytes following an adaptation of the method described elsewhere (Boyum, 1964; Sureda et al., 2006).
Erythrocyte fraction was obtained after centrifugation (900 x g, 30 min, 4ºC).
Then, erythrocytes were cleaned with phosphate buffered saline (PBS), centrifuged (900 x g, 20 min, 4ºC) and lysed with water at initial blood volume.
Cell lysates were stored at -80ºC until FA analyses.
FA composition of erythrocytes were determined by gas chromatography.
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Densitometry
Time Frame: 8 weeks
|
Densitometry was performed by Lunar IDXA (General Electric, USA)
|
8 weeks
|
Exercise stress test energy efficiency
Time Frame: 8 weeks
|
Standardized maximal treadmill exercise test
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Franchek Drobnic, Ph D, Centre D'Alt Rendiment, Sant Cugat
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Capo X, Martorell M, Sureda A, Tur JA, Pons A. Effects of docosahexaenoic supplementation and in vitro vitamin C on the oxidative and inflammatory neutrophil response to activation. Oxid Med Cell Longev. 2015;2015:187849. doi: 10.1155/2015/187849. Epub 2015 Apr 19.
- Pons V, Riera J, Capo X, Martorell M, Sureda A, Tur JA, Drobnic F, Pons A. Calorie restriction regime enhances physical performance of trained athletes. J Int Soc Sports Nutr. 2018 Mar 9;15:12. doi: 10.1186/s12970-018-0214-2. eCollection 2018.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (Actual)
January 1, 2012
Study Completion (Actual)
October 1, 2014
Study Registration Dates
First Submitted
July 7, 2015
First Submitted That Met QC Criteria
August 25, 2015
First Posted (Estimate)
August 26, 2015
Study Record Updates
Last Update Posted (Estimate)
August 26, 2015
Last Update Submitted That Met QC Criteria
August 25, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- CAR-1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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