Managing the Nutritional Needs of Older Filipino With Due Attention to Protein Nutrition and Functional Health (ManoPo) Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 68
- Locations
- 2
- Primary Endpoint
- Change in muscle strength, as measured by grip strength and leg strength (Jamar, MicroFET)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, 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 Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Intervention Group
A 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: Nutrition supplementation (Dietary Supplement)
Intervention Group
A 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: Exercise (Other)
Placebo Group
An 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: Nutrition supplementation (Dietary Supplement)
Placebo Group
An 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: Exercise (Other)
Outcomes
Primary Outcomes
Change in muscle strength, as measured by grip strength and leg strength (Jamar, MicroFET)
Time Frame: 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
Time Frame: Baseline, 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 battery
Time Frame: 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
Time Frame: 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)
Time Frame: 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 Outcomes
No secondary outcomes reported
Investigators
Robby Carlo A. Tan
Senior Science Research Specialist
Food and Nutrition Research Institute, Philippines