Skip to main content
OpenTrials
Completed

NCT Number: NCT05953116

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

The study aims to determine the effect of protein nutrition and exercise on the body composition and functional capacity of Filipino older adults.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Science and Technology-Food and Nutrition Research Institute

City of Taguig, National Capital Region, 1631, Philippines

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Protein drink

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.

Other names: Resistance and group exercise

Primary outcomes

  1. 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

  2. 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.

  3. 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

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

Food and Nutrition Research Institute, Philippines

Other Gov

Collaborators

  • Wageningen University and Research

Registry information

Official study title

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

Acronym: ManoPo

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 19, 2023
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.