Combining exercise and nutrition to improve health in older adults

Exercise and Nutrition for Healthy AgeiNg: Anabolic Interventions for Older People With (Pre)Sarcopenia to Improve Physical Functioning, Muscle Mass and Muscle Strength and to Understand the Underlying Mechanisms of Action.

This study is testing whether combining exercise with nutritional supplements can help older adults with muscle loss feel stronger and improve their overall health.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 180 (estimated)
• Ages: 65 Years and up
• Sex: All
• Sponsor: Universitaire Ziekenhuizen KU Leuven (other)
• Locations: 1 site (Leuven, Vlaams-Brabant)
• Trial ID: NCT03649698 on ClinicalTrials.gov

What this trial studies

This randomized placebo-controlled clinical trial evaluates the effects of combined anabolic interventions, including exercise and nutritional supplements, on physical performance in elderly individuals aged 65 and older who are experiencing (pre)sarcopenia. Participants will be assigned to one of five groups: exercise only, protein supplement only, exercise plus protein, omega-3 supplement, or placebo. The study will assess various outcomes such as muscle mass, strength, compliance with interventions, and overall functional and cognitive status. The trial aims to uncover the underlying mechanisms of action through blood measures and muscle biomarkers.

Who should consider this trial

Good fit: Ideal candidates are community-dwelling elderly individuals aged 65 and older with (pre)sarcopenia as defined by the European Working Group on Sarcopenia.

Not a fit: Patients with uncontrolled health issues, recent cardiovascular events, or significant pain on the day of exercise may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance physical performance and overall health in older adults, potentially reducing the impact of sarcopenia.

How similar studies have performed: Other studies have shown promising results with similar combined approaches to address sarcopenia, indicating potential for success.

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.

Where this trial is running

Leuven, Vlaams-Brabant

• Gerontology and Geriatrics, Department of Public Health and Primary Care, KU Leuven — Leuven, Vlaams-Brabant, Belgium (RECRUITING)

Study contacts

• Principal investigator: Evelien Gielen, Prof MD PhD — Gerontology and Geriatrics, Department of Public Health and primary care KU Leuven
• Study coordinator: Laur Vercauteren, MSc

Conditions: Sarcopenia, Nutrition, Protein, Vitamin D, Exercise, Older people, Frailty