NCT02533479

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 7, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 26, 2015

Completed
Last Updated

August 26, 2015

Status Verified

August 1, 2015

Enrollment Period

2 years

First QC Date

July 7, 2015

Last Update Submit

August 25, 2015

Conditions

Dietary Modification

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Secondary Outcomes (2)

  • Densitometry

    8 weeks

  • Exercise stress test energy efficiency

    8 weeks

Study Arms (1)

Caloric restriction

EXPERIMENTAL

three alternate days weekly along 4 weeks.

Other: Caloric restriction

Interventions

Caloric restrictionOTHER

three alternate days weekly along 4 weeks.

Caloric restriction

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • sex (female),
  • smokers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre D'Alt Rendinemt, Sant Cugat

Barcelona, 08174, Spain

Location

Related Publications (2)

  • 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.

    PMID: 25960826BACKGROUND

  • 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.

    PMID: 29556158DERIVED

MeSH Terms

Interventions

Caloric Restriction

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsEnergy IntakeDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Franchek Drobnic, Ph D

    Centre d'Alt Rendiment, Sant Cugat

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD in Medicine

Study Record Dates

First Submitted

July 7, 2015

First Posted

August 26, 2015

Study Start

January 1, 2010

Primary Completion

January 1, 2012

Study Completion

October 1, 2014

Last Updated

August 26, 2015

Record last verified: 2015-08

Locations

ES(1)