Leucine and ACEi to treat sarcopenia

Perindopril and leucine to improve muscle function in older people (LACE study)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN90094835

Enrollment

352

Registered

2015-02-18

Start date

2015-05-01

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Topic: Primary Care, Musculoskeletal disorders, Ageing

Interventions

Oral perindopril 4mg once daily vs placebo, and oral leucine 2.5g three times per day with meals vs placebo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age 70 and over 2. Sarcopenia criteria according to EWGSOP definition, based on: 2.1. Low total skeletal muscle mass on BioImpedance Assay (BIA) using the BIA 101 device (<13Kg for women, <20.5Kg for men) 2.2. Either low gait speed (<0.8 m/s on 4m walk) or low handgrip strength (<20Kg for women, <30Kg for men)

Exclusion criteria

Exclusion criteria: 1. Contraindications or existing indications to therapies or placebo 1.1. Known clinical diagnosis of chronic heart failure (by European Society of Cardiology criteria) 1.2. Confirmed LV systolic dysfunction on any imaging modality 1.3. Known aortic stenosis (peak gradient >30mmHg) 1.4. Systolic BP20/10mmHg (asymptomatic orthostatic hypotension will not be a contraindication) 1.6. Serum Creatinine >180 umol/L or eGFR5.0 mmol/L; Na10% in last 6 months (to exclude significant cachexia) 3.6. Known uncontrolled thyrotoxicosis 3.7. 7.5mg/day or greater prednisolone use (or equivalent)

Design outcomes

Primary

Measure	Time frame
Between group difference in Short Physical Performance Battery (SPPB) score at 12 months	—

Secondary

Measure	Time frame
Between group differences in: 1. Appendicular muscle mass/height squared (measured by dual energy-X ray absorptiometry) 2. Grip strength 3. Quadriceps strength (handheld dynamometry) 4. 6 minute walk test 5. Gait speed (4m walk) 6. Chair stands (Sit to stand test x 10) 7. Activities of daily living (Nottingham extended ADL questionnaire) and quality of life (EuroQol 5D questionnaire). 8. HOMA IR (Homeostatic Index of insulin resistance; measured from glucose and insulin levels) 9. Falls frequency, collected by monthly falls diary 10. Biomarkers of muscle metabolism and predictors of response to treatment: baseline 3 and 12 months Measured at baseline, 6 and 12 months, except for muscle mass, which is baseline and 12 months	—

Measure

Time frame

Between group differences in: 1. Appendicular muscle mass/height squared (measured by dual energy-X ray absorptiometry) 2. Grip strength 3. Quadriceps strength (handheld dynamometry) 4. 6 minute walk test 5. Gait speed (4m walk) 6. Chair stands (Sit to stand test x 10) 7. Activities of daily living (Nottingham extended ADL questionnaire) and quality of life (EuroQol 5D questionnaire). 8. HOMA IR (Homeostatic Index of insulin resistance; measured from glucose and insulin levels) 9. Falls frequency, collected by monthly falls diary 10. Biomarkers of muscle metabolism and predictors of response to treatment: baseline 3 and 12 months Measured at baseline, 6 and 12 months, except for muscle mass, which is baseline and 12 months

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Countries

Scotland, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 7, 2026