Sarcopenia
Conditions
Keywords
Sarcopenia, Body Composition, Protein, Exercise, Functional Status
Brief summary
The study aims to determine the effect of protein nutrition and exercise on the body composition and functional capacity of Filipino older adults.
Detailed description
The objective of the study is to determine the effects of nutrition supplementation and exercise intervention on the main indicators of sarcopenia in older adults such as body composition (fat mass and lean mass), muscle strength (leg and handgrip), and physical performance.
Interventions
DIETARY_SUPPLEMENTNutrition supplementation
Blinded researchers will provide the randomly assigned supplement product to the trial participants for a period of 90 days. Used packaging will be collected at the end of every week from each trial participant to monitor compliance.
OTHERExercise
Trained researchers will facilitate resistance-based exercises two to three times a week in an enclosed venue (gym). Trial participants will be assessed at baseline for one repetition maximum (1RM) which will serve as a basis for load progression. A target of 3 sets and 6-15 repetitions with at least 30 seconds rest in between sets will be performed by the trial participants under supervision of a trained researcher.
Sponsors
Wageningen University and Research
Food and Nutrition Research Institute, Philippines
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Masking description
The trial participants and researchers will be blinded during the conduct of the 12-week intervention. An independent third party will handle randomization and allocation of participants to either intervention group (DOST-FNRI protein drink + physical activity) or placebo group (placebo product + physical activity), while trying to ensure a balanced sex distribution between the groups. The intervention group will receive a protein-containing product which shall meet the target of 30g of protein per day of supplementation. Meanwhile, the placebo group will receive an isocaloric product (similar caloric value but with minimal to no protein content). Both products will have similar packaging, appearance, taste, and flavoring. A unique serial number only known by the independent third party will be used to differentiate between the two products. Unblinding of trial participants will be done after data analysis of a locked dataset.
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Pre-sarcopenia/pre-frail * Aged 60 years old and above, male or female * Free-living in the community, ambulatory * Able to respond to food recall/interview as self-declared * Normal cardiac function as measured by resting ECG
Exclusion criteria
* Bed ridden, unable to perform exercise independently * Presence of serious medical condition (i.e. cancer, existing fracture) * Presence of unmanaged hypertension and/or type 2 diabetes or upon assessment of physician * Renal Problem * Under controlled or medically-supervised diet not flexible to include the intervention agent * Allergic to any ingredients in the nutrition supplementation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in physical performance, as measured by short physical performance battery | Baseline, Midline (6 weeks), Endline (12 weeks) | Score ranges from 0 to 12 with a higher score indicating better functionality |
| Change in physical performance, as measured by 10-meter walk test | Baseline, Midline (6 weeks), Endline (12 weeks) | Faster walking speed (in meters per second) indicate better functionality |
| Change in muscle mass, as measured by dual-energy x-ray absorptiometry (DXA) | Baseline, Midline (6 weeks), Endline (12 weeks) | Measurement of appendicular skeletal muscle mass index (ASMI) by dividing total muscle mass (kg) of appendages with height in meters squared |
| Change in muscle strength, as measured by grip strength and leg strength (Jamar, MicroFET) | Baseline, Midline (6 weeks), Endline (12 weeks) | Handgrip strength is measured using a hydraulic hand dynamometer through maximum exertion of grip force (in kilograms). Leg strength is measured using a hand-held dynamometer. Participant will use strongest leg force to push against the resistance brought upon by the researcher while holding the measuring device. |
| Change in physical performance, as measured by timed up-and-go test | Baseline, Midline (6 weeks), Endline (12 weeks) | Faster time duration to complete the test indicate lesser risk for falls |
Countries
Philippines
Outcome results
None listed