Dietary ModificationNCT02533479
Erythrocytes and Skeletal-muscle Fatty Acids Are Positively Correlated After Caloric Restriction and Exercise
A study testing Caloric restriction in people with Dietary Modification, run by Centre d'Alt Rendiment at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Dietary Modification
- What is being tested?
- Caloric restriction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2010to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- age (18-50 years old),
- sex (male),
- equilibrate diet and physical activity of 3 days weekly.
Who cannot join
- sex (female),
- smokers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Dietary Modification
- Being tested
- Caloric restriction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caloric restrictionOther
three alternate days weekly along 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Caloric restriction | Experimental | three alternate days weekly along 4 weeks. Receives: Other: Caloric restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 8 weeks
Secondary outcomes (2)
Densitometry
Densitometry was performed by Lunar IDXA (General Electric, USA)
Measured: 8 weeks
Exercise stress test energy efficiency
Standardized maximal treadmill exercise test
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2015 (estimated)
- Study startJan 2010
- Primary completionJan 2012
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dietary ModificationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre d'Alt Rendiment
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, FRANCISCO DROBNIC, MD, PhD, Centre d'Alt Rendiment
- Investigators
- Franchek Drobnic, Ph D, Study chair, Centre d'Alt Rendiment, Sant Cugat
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02533479
- Sponsor's protocol ID
- CAR-1
- Status last verified
- Aug 2015
- First submitted
- 7 Jul 2015
- Last updated
- 26 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 25960826Pons 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.
PubMed 29556158
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erythrocytes and Skeletal-muscle Unsaturated and Omega-6 Fatty Acids Are Positively Correlated After Caloric Restriction and Exercise
- ClinicalTrials.gov ID
- NCT02533479
- Acronym / sponsor ID
- CAR-1
- Conditions
- Dietary Modification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Centre d'Alt RendimentUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 26 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Caloric restriction | Experimental | Other: Caloric restrictionthree alternate days weekly along 4 weeks. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- age (18-50 years old),
- sex (male),
- equilibrate diet and physical activity of 3 days weekly.
Key exclusion criteria (2 listed)
- sex (female),
- smokers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caloric restrictionthree alternate days weekly along 4 weeks. | Other | Caloric restriction |
Primary outcome
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.
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.
2 secondary outcomes
Densitometry
Time frame: 8 weeks
Exercise stress test energy efficiency
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2015.
- Background: PubMed 25960826Capo 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.
- Derived from this study: PubMed 29556158Pons 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Franchek Drobnic, Ph D study chair
Centre d'Alt Rendiment, Sant Cugat
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caloric restriction in people with Dietary Modification, run by Centre d'Alt Rendiment at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in skeletal muscle FAs profiles in adult healthy human after caloric restriction and acute exercise (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02533479, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2015.