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

Dietary Modification Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02533479
• Other study ID #: CAR-1
• Status: Completed
• Phase: N/A
• First received: July 7, 2015
• Last updated: August 25, 2015
• Start date: January 2010
• Est. completion date: October 2014

Study information

• Verified date: August 2015
• Source: Centre d'Alt Rendiment
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: October 2014
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• age (18-50 years old),

• sex (male),

• equilibrate diet and physical activity of 3 days weekly.

Exclusion Criteria:

• sex (female),

• smokers.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Dietary Modification

Intervention

Other:
• Caloric restriction
three alternate days weekly along 4 weeks.

Locations

Country	Name	City	State
Spain	Centre D'Alt Rendinemt, Sant Cugat	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Centre d'Alt Rendiment

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Capó 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in skeletal muscle FAs profiles in adult healthy human after caloric restriction and acute exercise	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	Yes
Primary	Changes in erythrocytes FAs profiles in adult healthy human after caloric restriction and acute exercise	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	Yes
Secondary	Densitometry	Densitometry was performed by Lunar IDXA (General Electric, USA)	8 weeks	Yes
Secondary	Exercise stress test energy efficiency	Standardized maximal treadmill exercise test	8 weeks	Yes