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Managing the Nutritional Needs of Older Filipino with Due Attention to Protein Nutrition and Functional Health Study

Not Applicable
Completed
Conditions
Sarcopenia
Interventions
Dietary Supplement: Nutrition supplementation
Other: Exercise
Registration Number
NCT05953116
Lead Sponsor
Food and Nutrition Research Institute, Philippines
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
68
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Placebo GroupExerciseAn isocaloric product (made with maltodextrin) in powdered form with flavoring. Product will be added to 180-200 mL of warm water prior to consumption.
Intervention GroupExerciseA protein product (combination of whey protein and plant-derived protein) in powdered form with flavoring. Product will be added to 180-200 mL of warm water prior to consumption.
Intervention GroupNutrition supplementationA protein product (combination of whey protein and plant-derived protein) in powdered form with flavoring. Product will be added to 180-200 mL of warm water prior to consumption.
Placebo GroupNutrition supplementationAn isocaloric product (made with maltodextrin) in powdered form with flavoring. Product will be added to 180-200 mL of warm water prior to consumption.
Primary Outcome Measures
NameTimeMethod
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 testBaseline, Midline (6 weeks), Endline (12 weeks)

Faster time duration to complete the test indicate lesser risk for falls

Change in physical performance, as measured by short physical performance batteryBaseline, 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 testBaseline, 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

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Department of Science and Technology-Food and Nutrition Research Institute

🇵🇭

Taguig, Metro Manila, Philippines

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