NCT03649698 Exercise and Nutrition for Healthy AgeiNg
| NCT ID | NCT03649698 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universitaire Ziekenhuizen KU Leuven |
| Condition | Sarcopenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 180 participants |
| Start Date | 2018-02-12 |
| Primary Completion | 2024-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 180 participants in total. It began in 2018-02-12 with a primary completion date of 2024-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The aim of this randomized placebo-controlled 5-arm clinical trial is to evaluate the effect of combined anabolic interventions compared to single or placebo interventions on physical performance in community-dwelling (pre)sarcopenic elderly (≥ 65 years) and to determine the underlying mechanisms of action. Important secondary outcome measures are muscle mass, muscle strength, compliance to the interventions (exercise program, protein and omega-3 supplementation) and functional, cognitive and nutritional status.
Eligibility Criteria
Inclusion Criteria: 1. Male or female persons with (pre)sarcopenia according to the European Working Group on Sarcopenia in Older People (EWGSOP): reduced muscle mass without (presarcopenia) or with (sarcopenia) reduced walking speed (≤ 0.8m/s) or muscle strength OR probable, confirmed or severe sarcopenia according to EWGSOP 2. 2. 65 years or older; 3. Community-dwelling elderly or assisted living; 4. In case of one or more positive answer(s) on the health screen for exercise, subjects need approval of their general practitioner to participate in this randomized controlled trial (RCT). * Uncontrolled or unstable health problems * Uncontrolled pain or feeling unwell the day of the exercise * Recently diagnosed cardiovascular events * systolic blood pressure (SBP) ≥ 180 mmHg and/or diastolic blood pressure (DBP) ≥ 100 mmHg * Resting tachycardia \> 100 bpm * Uncontrolled atrial or ventricular arrhythmias * Unstable or acute heart failure * Lasting, increased pain following a previous session * Suspected acute injury * Recent injurious fall without medical assessment * Severe breathlessness or dizziness * Uncontrolled pulmonary problems * Rheumatoid arthritis flare up or acute systemic illness/infection * Unexplained lethargy Exclusion Criteria: 1. Impairments/diseases that impose problems to participation in the study; 2. Allergy to milk or soy or peanut; 3. Mini-Mental State Examination (MMSE) \< 21; 4. Terminal illness (prognosis \< 6 months); 5. Persons who followed a physical training program in the last 6 months (twice or more/week); 6. Persons with a daily intake of \> 1.5 g protein/kg body weight (BW)/day; 7. Diagnosis of severe kidney disease (GFR \< 30 ml/min) or diabetes mellitus; 8. Unable to communicate in Dutch, English or French.
Contact & Investigator
Evelien Gielen, Prof MD PhD
PRINCIPAL INVESTIGATOR
Gerontology and Geriatrics, Department of Public Health and primary care KU Leuven
Frequently Asked Questions
Who can join the NCT03649698 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Sarcopenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03649698 currently recruiting?
Yes, NCT03649698 is actively recruiting participants. Contact the research team at laura.vercauteren@kuleuven.be for enrollment information.
Where is the NCT03649698 trial being conducted?
This trial is being conducted at Leuven, Belgium.
Who is sponsoring the NCT03649698 clinical trial?
NCT03649698 is sponsored by Universitaire Ziekenhuizen KU Leuven. The principal investigator is Evelien Gielen, Prof MD PhD at Gerontology and Geriatrics, Department of Public Health and primary care KU Leuven. The trial plans to enroll 180 participants.