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Completed

NCT Number: NCT02533479

Erythrocytes and Skeletal-muscle 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.

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Key information

Conditions

Dietary Modification

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Centre D'Alt Rendinemt, Sant Cugat

Barcelona, 08174, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • sex (female),
  • smokers.

Treatment and study plan

Caloric restriction

Other

three alternate days weekly along 4 weeks.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Densitometry

    Time frame: 8 weeks

    Densitometry was performed by Lunar IDXA (General Electric, USA)

  2. Exercise stress test energy efficiency

    Time frame: 8 weeks

    Standardized maximal treadmill exercise test

Sponsors and collaborators

Lead sponsor

Centre d'Alt Rendiment

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2014
First posted
Aug 26, 2015
Registry last updated
Aug 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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