Exercise and Nutrition for Healthy AgeiNg

NCT03649698 | Recruiting

• 1 other identifier: S60763
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcopenia

Keywords

Sarcopenia; Nutrition; Protein; Vitamin D; Exercise; Older people; Frailty

Outcome Measures

Primary Outcomes (2)

• Change in physical functioning

  Change in SPPB score

  Measured at baseline, week 12 and week 24.

• Percentage of participants with change in physical functioning

  the percentage of participants with more than 1 or 1 point increase in SPPB score.

  Measured at baseline, week 12 and week 24.

Secondary Outcomes (44)

• Change in muscle mass (after intervention-baseline)

  Measured at screening, week 12 and week 24 with DXA or when screening is 6 weeks prior to baseline, DXA will also be performed at baseline. At screening, baseline, week 12 and week 24 with BIA.

• Change in muscle strength (after intervention-baseline)

  Hand grip measured at screening, baseline, week 12 and week 24. Biodex measured at baseline, week 12 and week 24.

• Compliance to the exercise intervention, subjective

  baseline until week 12

• Compliance to the exercise intervention, objective

  baseline until week 12

• Compliance to the exercise intervention, subjective, detailed

  baseline until week 12

Study Arms (5)

Home-based training program

EXPERIMENTAL

Home-based training program + protein placebo + omega-3 placebo

Behavioral: Home-based training program; Drug: Placebo protein powder; Drug: Placebo omega-3

High-quality protein supplement

EXPERIMENTAL

High-quality protein supplement + omega-3 placebo

Dietary Supplement: High-quality protein supplement; Drug: Placebo omega-3

2 Anabolic interventions

EXPERIMENTAL

Home-based training program and high quality protein supplement

Behavioral: Home-based training program; Dietary Supplement: High-quality protein supplement; Drug: Placebo omega-3

3 Anabolic interventions

EXPERIMENTAL

Home-based training program, high-quality protein supplement and omega-3 fatty acids

Behavioral: Home-based training program; Dietary Supplement: High-quality protein supplement; Dietary Supplement: Omega-3 fatty acid

Placebo protein powder and omega-3

PLACEBO COMPARATOR

Control group: protein placebo + omega-3 placebo

Drug: Placebo protein powder; Drug: Placebo omega-3

Interventions

Home-based training program BEHAVIORAL

Exercise intervention: During the intervention period, the participant will perform the optimized and personally adapted Otago Exercise Program (OEP). The participant is encouraged to perform the resistance exercises three times a week with a rest day in between. The participant is advised to perform the exercises in close temporal proximity to one of the moments of the intake of the protein supplement. The participant will also follow a walking plan in which he or she needs to walk 30 minutes twice a week. These 30 minutes can be broken down to three 10-minute walks throughout the day. During the follow-up period, participants may continue the OEP, but no personal encouragement will be given during this period.

2 Anabolic interventions; 3 Anabolic interventions; Home-based training program

High-quality protein supplement DIETARY_SUPPLEMENT

The participant will receive an individually adapted protein supplement to achieve the recommend total (usual diet and supplements) daily intake of 1.5 g/protein/kg for frail elderly. This will be realized by adding an individualized amount (g) of protein powder during breakfast, lunch, dinner or snack between meals, or before breakfast or after dinner, based on the subjects' food intake assessed by a food diary. The participant will take the protein supplement from 5 days before the start of the intervention. The protein powder is commercially available and consists of 4.5g protein/5g powder. During the follow-up, no protein supplement is added.

2 Anabolic interventions; 3 Anabolic interventions; High-quality protein supplement

Omega-3 fatty acid DIETARY_SUPPLEMENT

Four weeks before the start of the intervention, the participant will start the intake of 1 omega-3 capsule providing in total 500 mg EPA and 450 mg DHA until the end of the intervention. He or she has to take the supplement once daily at a chosen time. During the follow-up, no omega-3 supplement will be given.

3 Anabolic interventions

Placebo protein powder DRUG

Isocaloric maltodextrin powder. Amount based on food diary.

Home-based training program; Placebo protein powder and omega-3

Placebo omega-3 DRUG

Peanut oil soft gel capsules. 1g/ capsule. 1 capsule/day

2 Anabolic interventions; High-quality protein supplement; Home-based training program; Placebo protein powder and omega-3

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.
• years or older;
• Community-dwelling elderly or assisted living;
• 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

You may not qualify if:

• Impairments/diseases that impose problems to participation in the study;
• Allergy to milk or soy or peanut;
• Mini-Mental State Examination (MMSE) \< 21;
• Terminal illness (prognosis \< 6 months);
• Persons who followed a physical training program in the last 6 months (twice or more/week);
• Persons with a daily intake of \> 1.5 g protein/kg body weight (BW)/day;
• Diagnosis of severe kidney disease (GFR \< 30 ml/min) or diabetes mellitus;
• Unable to communicate in Dutch, English or French.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• KU Leuven: collaborator
• VISTA-Life: collaborator
• Nestle Health Science: collaborator

Study Sites (1)

Gerontology and Geriatrics, Department of Public Health and Primary Care, KU Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

Related Publications (4)

• Amini N, Dupont J, Lapauw L, Vercauteren L, Peeters L, Dedeyne L, Verschueren S, Tournoy J, Gielen E. A multicomponent intervention consisting of exercise, proteins and omega-3 supplementation to improve sarcopenia in community-dwelling older adults: Lessons learned from a 5-armed randomized controlled feasibility trial. J Frailty Aging. 2026 Feb 2;15(1):100129. doi: 10.1016/j.tjfa.2025.100129. Online ahead of print.

  PMID: 41632571 DERIVED

• Amini N, Devriendt A, Lapauw L, Dupont J, Vercauteren L, Verbeke K, Verschueren S, Tournoy J, Gielen E. Estimating protein intake in sarcopenic older adults: combining food diaries and weighed powders versus 24-hour urine collections. J Nutr Health Aging. 2025 Mar;29(3):100474. doi: 10.1016/j.jnha.2024.100474. Epub 2025 Jan 8.

  PMID: 39787986 DERIVED

• Lapauw L, Dupont J, Amini N, Vercauteren L, Verschueren S, Tournoy J, Raes J, Gielen E. Trial in Elderly with Musculoskeletal Problems due to Underlying Sarcopenia-Faeces to Unravel the Gut and Inflammation Translationally (TEMPUS-FUGIT): protocol of a cross-sequential study to explore the gut-muscle axis in the development and treatment of sarcopenia in community-dwelling older adults. BMC Geriatr. 2023 Sep 26;23(1):599. doi: 10.1186/s12877-023-04291-5.

  PMID: 37752426 DERIVED

• Dedeyne L, Dupont J, Koppo K, Verschueren S, Tournoy J, Gielen E. Exercise and Nutrition for Healthy AgeiNg (ENHANce) project - effects and mechanisms of action of combined anabolic interventions to improve physical functioning in sarcopenic older adults: study protocol of a triple blinded, randomized controlled trial. BMC Geriatr. 2020 Dec 10;20(1):532. doi: 10.1186/s12877-020-01900-5.

  PMID: 33302879 DERIVED

MeSH Terms

Conditions

Sarcopenia; Motor Activity; Frailty

Interventions

Fatty Acids, Omega-3

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Behavior; Pathologic Processes

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• Evelien Gielen, Prof MD PhD

  Gerontology and Geriatrics, Department of Public Health and primary care KU Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laur Vercauteren, MSc

CONTACT

+32 16 34 38 67; laura.vercauteren@kuleuven.be

Jolan Dupont, MD

CONTACT

+32 16 34 32 01; jolan.dupont@uzleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: * Participant: Yes blinded for protein and omega-3 * Investigator: Yes blinded for protein and omega-3 * Outcomes Assessor: Yes blinded for protein and omega-3 * No blinding for exercise intervention. * Statistician is blinded for protein, omega-3 and exercise intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2018
• First Posted: August 28, 2018
• Study Start: February 12, 2018
• Primary Completion: December 1, 2024
• Study Completion: June 1, 2025
• Last Updated: June 28, 2024

Record last verified: 2024-06

Locations

BE (1)