AzTrials
AzTrials

SupplementationNCT07143305

Effect of Citrulline Malate Supplementation on Physical Function and Biochemical Parameters in Physically Active Older Women

A study testing Multicomponent physical exercise programme in people with Supplementation, run by Universidad de Burgos at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

A randomised, double-blind, placebo-controlled pilot trial was conducted with thirty-three community-dwelling women aged 65 years or over. Participants were assigned to a multicomponent training programme (three days per week) and received either 3 g per day of citrulline malate or a placebo. Read more about this study

Who is it for?
Ages 60 to 75 years, women onlyHealthy volunteers can take part
Conditions the study is for
Supplementation
What is being tested?
Multicomponent physical exercise programme
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteSpain
Study dates
15 Mar 2020to 15 May 2020
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 60 to 75 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Sex: women.
  • Age: 60-75 years.

Who cannot join

  • Functional limitations (Barthel Index <100 and/or Lawton-Brody Scale <8).
  • Musculoskeletal injuries within the past six months.
  • Cardiovascular disease (e.g. advanced heart failure, unstable angina, recent myocardial infarction, arrhythmias, uncontrolled hypertension or hypotension, aortic stenosis, thromboembolic events).
  • Respiratory disorders (e.g. chronic respiratory failure or a moderate/severe BODEx index).
  • Endocrine/metabolic diseases (e.g. uncontrolled diabetes).
  • Neurological or psychiatric disorders (e.g. dementia).
  • Prior use of ergogenic nutritional supplements.
  • Any other condition deemed incompatible with moderate physical activity by the clinical team.

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • City Council of Soria

    Soria

Other trials in Spain

About this study

Official title: Effect of Citrulline Malate Supplementation During a Multicomponent Exercise Program on Physical Function and Biochemical Parameters in Physically Active Older Women: a Randomised Controlled Pilot Trial

A randomised, double-blind, placebo-controlled pilot trial was conducted with thirty-three community-dwelling women aged 65 years or over. Participants were assigned to a multicomponent training programme (three days per week) and received either 3 g per day of citrulline malate or a placebo. Assessments were conducted before and after the intervention, including tests of physical performance (6MWT, sit-to-stand, SPPB), blood biomarkers (vitamin D, glucose, CK, hormones), and perceived quality of life (WHOQOL-BREF).

Conditions
Supplementation
Being tested
Multicomponent physical exercise programme
Keywords
citrulline, Physical Performance, older women

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multicomponent physical exercise programmeOther

    Participants engaged in a multicomponent physical exercise programme designed specifically for older adults. The programme was based on the latest evidence and international recommendations for sarcopenia and functional maintenance in ageing population.

Study groups in NCT07143305
Study groupRoleWhat they receive
PlaceboActive comparatorPlacebo supplementation with 3 g/day of maltodextrine
Receives: Other: Multicomponent physical exercise programme
SupplementationExperimental3 g/day of citrulline malate
Receives: Other: Multicomponent physical exercise programme

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Handgrip strength

    Handgrip strength (kg) was assessed with a digital handheld dynamometer (JAMAR®, 0-90 kg; Performance Health, Warrenville, IL, USA), by standardised procedures.

    Measured: At baseline, immediately before the start of the supplementation protocol, and at the end of the six-week intervention period, within 24 hours of the final exercise session

  2. Cardiorespiratory

    Cardiorespiratory fitness was evaluated using the six-minute walk test (6MWT) on a standardised indoor 400-metre track.

    Measured: At baseline, immediately before the start of the supplementation protocol, and at the end of the six-week intervention period, within 24 hours of the final exercise session

  3. Gait speed

    Gait speed was measured over four metres using photoelectric timing gates. Participants began walking five metres before the start line to ensure a consistent pace throughout the timed section.

    Measured: At baseline, immediately before the start of the supplementation protocol, and at the end of the six-week intervention period, within 24 hours of the final exercise session

  4. Lower limb strength

    Lower limb strength was assessed using the Five Times Sit-to-Stand Test (5xSTS), which involved recording the time taken to rise from a 45 cm highchair five times as quickly as possible without using the arms for support.

    Measured: At baseline, immediately before the start of the supplementation protocol, and at the end of the six-week intervention period, within 24 hours of the final exercise session

  5. Balance

    Balance was assessed via static balance testing in three different stances, held for 10 seconds each: side-by-side, semi-tandem and tandem

    Measured: At baseline, immediately before the start of the supplementation protocol, and at the end of the six-week intervention period, within 24 hours of the final exercise session

  6. Frailty and global physical function

    Frailty and global physical function were evaluated using the Short Physical Performance Battery (SPPB), which incorporates tests of gait speed, balance, and the ability to rise from a chair. Based on the total score obtained in all tests (range from 0 to 10), participants are identified as having severe limitations (0-4), moderate limitations (4-6), mild limitations (7-9) and minimal limitations (10-12).

    Measured: At baseline, immediately before the start of the supplementation protocol, and at the end of the six-week intervention period, within 24 hours of the final exercise session

  7. High-density lipoprotein (HDL)

    High-density lipoprotein (HDL) was evaluated to explore potential cardiovascular implications.

    Venous blood samples were collected under standardised conditions between 08:00 and 08:30 a.m., following a minimum of 12 hours' fasting and at least eight hours' rest overnight. All extractions were performed by a certified nurse at an accredited clinical laboratory (Det Norske Veritas, certification no. 18031, Spain). A total of 10 ml of serum was drawn into clot-activator tubes, centrifuged and stored at -20 °C until analysis. Meanwhile, 3-5 mL of plasma was collected in EDTA® tubes and refrigerated at 4 °C for subsequent processing. All analytical procedures were conducted using standardised and validated platforms. Haematological assessments were performed using the Coulter Counter MAX-M® system, while biochemical and hormonal analyses were conducted using the Architect 2000® analyser (Abbott Diagnostics).

    Measured: At baseline, immediately before the start of the supplementation protocol, and at the end of the six-week intervention period, within 24 hours of the final exercise session

  8. Creatine kinase

    Creatine kinase was measured as an indicator of muscle damage.

    Venous blood samples were collected under standardised conditions between 08:00 and 08:30 a.m., following a minimum of 12 hours' fasting and at least eight hours' rest overnight. All extractions were performed by a certified nurse at an accredited clinical laboratory (Det Norske Veritas, certification no. 18031, Spain).

    A total of 10 ml of serum was drawn into clot-activator tubes, centrifuged and stored at -20 °C until analysis. Meanwhile, 3-5 mL of plasma was collected in EDTA® tubes and refrigerated at 4 °C for subsequent processing.

    All analytical procedures were conducted using standardised and validated platforms. Haematological assessments were performed using the Coulter Counter MAX-M® system, while biochemical and hormonal analyses were conducted using the Architect 2000® analyser (Abbott Diagnostics).

    Measured: At baseline, immediately before the start of the supplementation protocol, and at the end of the six-week intervention period, within 24 hours of the final exercise session

  9. Liver enzyme activity

    Liver enzyme activity was assessed via serum levels of aspartate aminotransferase (AST/GOT) and alanine aminotransferase (ALT/GPT).

    Venous blood samples were collected under standardised conditions between 08:00 and 08:30 a.m., following a minimum of 12 hours' fasting and at least eight hours' rest overnight. All extractions were performed by a certified nurse at an accredited clinical laboratory (Det Norske Veritas, certification no. 18031, Spain).

    A total of 10 ml of serum was drawn into clot-activator tubes, centrifuged and stored at -20 °C until analysis. Meanwhile, 3-5 mL of plasma was collected in EDTA® tubes and refrigerated at 4 °C for subsequent processing.

    All analytical procedures were conducted using standardised and validated platforms. Haematological assessments were performed using the Coulter Counter MAX-M® system, while biochemical and hormonal analyses were conducted using the Architect 2000® analyser (Abbott Diagnostics).

    Measured: At baseline, immediately before the start of the supplementation protocol, and at the end of the six-week intervention period, within 24 hours of the final exercise session

  10. Low-density lipoprotein (LDL)

    Low-density lipoprotein (HDL) was evaluated to explore potential cardiovascular implications.

    Venous blood samples were collected under standardised conditions between 08:00 and 08:30 a.m., following a minimum of 12 hours' fasting and at least eight hours' rest overnight. All extractions were performed by a certified nurse at an accredited clinical laboratory (Det Norske Veritas, certification no. 18031, Spain). A total of 10 ml of serum was drawn into clot-activator tubes, centrifuged and stored at -20 °C until analysis. Meanwhile, 3-5 mL of plasma was collected in EDTA® tubes and refrigerated at 4 °C for subsequent processing. All analytical procedures were conducted using standardised and validated platforms. Haematological assessments were performed using the Coulter Counter MAX-M® system, while biochemical and hormonal analyses were conducted using the Architect 2000® analyser (Abbott Diagnostics).

    Measured: At baseline, immediately before the start of the supplementation protocol, and at the end of the six-week intervention period, within 24 hours of the final exercise session

  11. Glucose

    Glucose provided insight into metabolic regulation. Venous blood samples were collected under standardised conditions between 08:00 and 08:30 a.m., following a minimum of 12 hours' fasting and at least eight hours' rest overnight. All extractions were performed by a certified nurse at an accredited clinical laboratory (Det Norske Veritas, certification no. 18031, Spain). A total of 10 ml of serum was drawn into clot-activator tubes, centrifuged and stored at -20 °C until analysis. Meanwhile, 3-5 mL of plasma was collected in EDTA® tubes and refrigerated at 4 °C for subsequent processing. All analytical procedures were conducted using standardised and validated platforms. Haematological assessments were performed using the Coulter Counter MAX-M® system, while biochemical and hormonal analyses were conducted using the Architect 2000® analyser (Abbott Diagnostics).

    Measured: At baseline, immediately before the start of the supplementation protocol, and at the end of the six-week intervention period, within 24 hours of the final exercise session

  12. Testosterone

    Testosterone was used to evaluate the hormonal status and potential anabolic-catabolic shifts.

    Venous blood samples were collected under standardised conditions between 08:00 and 08:30 a.m., following a minimum of 12 hours' fasting and at least eight hours' rest overnight. All extractions were performed by a certified nurse at an accredited clinical laboratory (Det Norske Veritas, certification no. 18031, Spain). A total of 10 ml of serum was drawn into clot-activator tubes, centrifuged and stored at -20 °C until analysis. Meanwhile, 3-5 mL of plasma was collected in EDTA® tubes and refrigerated at 4 °C for subsequent processing. All analytical procedures were conducted using standardised and validated platforms. Haematological assessments were performed using the Coulter Counter MAX-M® system, while biochemical and hormonal analyses were conducted using the Architect 2000® analyser (Abbott Diagnostics).

    Measured: At baseline, immediately before the start of the supplementation protocol, and at the end of the six-week intervention period, within 24 hours of the final exercise session

Secondary outcomes (1)
  1. Quality of life questionnaire

    Quality of life was measured using the World Health Organization Quality of Life Questionnaire - Brief Version (WHOQOL-BREF). The scale ranges from 0 to 100. Higher scores indicate a higher quality of life.

    Measured: At baseline, immediately before the start of the supplementation protocol, and at the end of the six-week intervention period, within 24 hours of the final exercise session

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2025
  2. Study start15 Mar 2020
  3. Primary completion15 Apr 2020
  4. Study completion15 May 2020

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07143305
Sponsor's protocol ID
CITMAL
Status last verified
Aug 2025
First submitted
8 Aug 2025
Last updated
2 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Multicomponent physical exercise programme in people with Supplementation, run by Universidad de Burgos 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 2 inclusion and 8 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 2 Oct 2025. 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?

Handgrip strength (time frame: At baseline, immediately before the start of the supplementation protocol, and at the end of the six-week intervention period, within 24 hours of the final exercise session). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 2 Oct 2025.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in