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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Active Comparator | Placebo supplementation with 3 g/day of maltodextrine |
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| Supplementation | Experimental | 3 g/day of citrulline malate |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multicomponent physical exercise programme | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Handgrip strength | Handgrip strength (kg) was assessed with a digital handheld dynamometer (JAMAR®, 0-90 kg; Performance Health, Warrenville, IL, USA), by standardised procedures. | 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 | Cardiorespiratory fitness was evaluated using the six-minute walk test (6MWT) on a standardised indoor 400-metre track. | 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 | 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. | 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 | 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. | 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 | Balance was assessed via static balance testing in three different stances, held for 10 seconds each: side-by-side, semi-tandem and tandem | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 |
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Each participant underwent a comprehensive medical evaluation by their primary care physician to confirm their health status and eligibility.
Inclusion criteria:
Exclusion criteria:
Identified as women
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City Council of Soria | Soria | Spain |
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| 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). | 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 |
| 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). | 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 |
| 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). | 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 |
| 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). | 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 |
| 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). | 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 |
| 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). | 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 |
| 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). | 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 |