Exercise and Nutrition for Healthy AgeiNg

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

Interventions

BEHAVIORAL

Home-based training program

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.

DIETARY_SUPPLEMENT

High-quality protein 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.

DIETARY_SUPPLEMENT

Omega-3 fatty acid

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.

DRUG

Placebo protein powder

Isocaloric maltodextrin powder. Amount based on food diary.

DRUG

Placebo omega-3

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

Sponsors & Collaborators

• KU Leuven

  collaborator OTHER

• VISTA-Life

  collaborator UNKNOWN

• Nestle Health Science

  collaborator INDUSTRY

• Universitaire Ziekenhuizen KU Leuven

  lead OTHER

Principal Investigators

• Evelien Gielen, Prof MD PhD · Gerontology and Geriatrics, Department of Public Health and primary care KU Leuven

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-02-12

Primary Completion

2024-12-31

Completion

2025-06-30

Countries

• Belgium

Study Locations