CompletedNot Applicable

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

Spain20 participantsStarted 2020-03-15

Plain-language 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. 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).

Who can participate

Age range60 Years – 75 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Each participant underwent a comprehensive medical evaluation by their primary care physician to confirm their health status and eligibility. Inclusion criteria: * Sex: women. * Age: 60-75 years. Exclusion criteria: * 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.

What they're measuring

Handgrip strength

Timeframe: 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

Cardiorespiratory

Timeframe: 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

Gait speed

Timeframe: 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

Lower limb strength

Timeframe: 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

Balance

Timeframe: 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

Frailty and global physical function

Timeframe: 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

Trial details

NCT IDNCT07143305

SponsorUniversidad de Burgos

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-04-15

View on ClinicalTrials.gov More Supplementation trials

Plain-language summary

Who can participate

Age range60 Years – 75 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Handgrip strength

Timeframe: 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

Cardiorespiratory

Timeframe: 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

Gait speed

Timeframe: 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

Lower limb strength

Timeframe: 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

Balance

Timeframe: 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

Frailty and global physical function

Timeframe: 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