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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Managing the Nutritional Needs of Older Filipino With Due Attention to Protein Nutrition and Functional Health (Mano Po) Study

Conditions
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Sarcopenia

Intervention / Treatment
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* Dietary Supplement: Nutrition supplementation
* Other: Exercise


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention Group<br>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. | Dietary Supplement: Nutrition supplementation<br>* 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.<br>* Other names: Protein drink;Other: Exercise<br>* 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.<br>* Other names: Resistance and group exercise;|
| Placebo Comparator: Placebo Group<br>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. | Dietary Supplement: Nutrition supplementation<br>* 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.<br>* Other names: Protein drink;Other: Exercise<br>* 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.<br>* Other names: Resistance and group exercise;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in muscle mass, as measured by dual-energy x-ray absorptiometry (DXA) | Measurement of appendicular skeletal muscle mass index (ASMI) by dividing total muscle mass (kg) of appendages with height in meters squared | Baseline, Midline (6 weeks), Endline (12 weeks) | 
| Change in muscle strength, as measured by grip strength and leg strength (Jamar, MicroFET) | 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. | Baseline, Midline (6 weeks), Endline (12 weeks) | 
| Change in physical performance, as measured by timed up-and-go test | Faster time duration to complete the test indicate lesser risk for falls | Baseline, Midline (6 weeks), Endline (12 weeks) | 
| Change in physical performance, as measured by short physical performance battery | Score ranges from 0 to 12 with a higher score indicating better functionality | Baseline, Midline (6 weeks), Endline (12 weeks) | 
| Change in physical performance, as measured by 10-meter walk test | Faster walking speed (in meters per second) indicate better functionality | Baseline, Midline (6 weeks), Endline (12 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sarcopenia, Body Composition, Protein, Exercise, Functional Status