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

NCT ID: NCT07143305

Last Updated: 2025-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-15
• Study Completion Date: 2020-05-15

Brief 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).

Conditions

Supplementation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Placebo supplementation with 3 g/day of maltodextrine

Group Type: ACTIVE_COMPARATOR

Multicomponent physical exercise programme

Intervention Type: OTHER

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.

Supplementation

3 g/day of citrulline malate

Group Type: EXPERIMENTAL

Multicomponent physical exercise programme

Intervention Type: OTHER

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.

Interventions

Multicomponent physical exercise programme

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Universidad de Burgos

OTHER

Sponsor Role: lead

Responsible Party

Juan Francisco Mielgo

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

City Council of Soria

Soria, , Spain

Countries

Spain

Other Identifiers

CITMAL

Identifier Type: -

Identifier Source: org_study_id