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

NCT ID: NCT05953116

Last Updated: 2025-03-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-04

Study Completion Date

2024-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sarcopenia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators
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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

Nutrition supplementation

Intervention Type 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.

Exercise

Intervention Type 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.

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.

Group Type PLACEBO_COMPARATOR

Nutrition supplementation

Intervention Type 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.

Exercise

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nutrition supplementation

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.

Intervention Type DIETARY_SUPPLEMENT

Exercise

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.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Protein drink Resistance and group exercise

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Wageningen University and Research

OTHER

Sponsor Role collaborator

Food and Nutrition Research Institute, Philippines

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Robby Carlo A. Tan

Senior Science Research Specialist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Robby Carlo A Tan, Msc

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Science and Technology-Food and Nutrition Research Institute

City of Taguig, National Capital Region, Philippines

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Philippines

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

FIERC-2022-019

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Sarcopenic Obesity as a Risk of Premature Aging
NCT05443711 ACTIVE_NOT_RECRUITING
Breathing & Blood Pressure
NCT05632406 RECRUITING