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Clinical Trials/NCT02533479
NCT02533479CompletedNot Applicable

Erythrocytes and Skeletal-muscle Unsaturated and Omega-6 Fatty Acids Are Positively Correlated After Caloric Restriction and Exercise

Centre d'Alt Rendiment2 sites in 1 country11 target enrollmentStarted: January 1, 2010Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
11
Locations
2
Primary Endpoint
Changes in erythrocytes FAs profiles in adult healthy human after caloric restriction and acute exercise

Study Overview

Brief Summary

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.

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
18 Years to 50 Years (Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • age (18-50 years old),
  • sex (male),
  • equilibrate diet and physical activity of 3 days weekly.

Exclusion Criteria

  • sex (female),

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

  • Exercise stress test energy efficiency(8 weeks)
  • Densitometry(8 weeks)

Investigators

Sponsor
Centre d'Alt Rendiment
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

FRANCISCO DROBNIC, MD, PhD

PhD in Medicine

Centre d'Alt Rendiment

Study Sites (2)

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