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

NCT05953116 | Completed DMC

• 1 other identifier: FIERC-2022-019
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcopenia

Keywords

Sarcopenia; Body Composition; Protein; Exercise; Functional Status

Outcome Measures

Primary Outcomes (5)

• 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)

Study Arms (2)

Intervention Group

ACTIVE COMPARATOR

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; Other: Exercise

Placebo Group

PLACEBO COMPARATOR

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; Other: Exercise

Interventions

Nutrition supplementation DIETARY_SUPPLEMENT

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.

Also known as: Protein drink

Intervention Group; Placebo Group

Exercise OTHER

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.

Also known as: Resistance and group exercise

Intervention Group; Placebo Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Food and Nutrition Research Institute, Philippines: lead
• Wageningen University and Research: collaborator

Study Sites (1)

Department of Science and Technology-Food and Nutrition Research Institute

City of Taguig, National Capital Region, 1631, Philippines

Location

MeSH Terms

Conditions

Sarcopenia; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Robby Carlo A Tan, Msc

  Department of Science and Technology-Food and Nutrition Research Institute (DOST-FNRI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Science Research Specialist

Study Record Dates

• First Submitted: July 12, 2023
• First Posted: July 19, 2023
• Study Start: September 4, 2023
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

PH (1)