Exercise and Nutrition for Healthy AgeiNg

• Status: Recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universitaire Ziekenhuizen Leuven
• Collaborators: KU Leuven; Nestlé Health Science Belgium; VISTA-Life

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.