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
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
68 participants
INTERVENTIONAL
2023-09-04
2024-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
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
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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.
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.
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.
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.
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.
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
60 Years
ALL
Yes
Sponsors
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Wageningen University and Research
OTHER
Food and Nutrition Research Institute, Philippines
OTHER_GOV
Responsible Party
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Robby Carlo A. Tan
Senior Science Research Specialist
Principal Investigators
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Robby Carlo A Tan, Msc
Role: PRINCIPAL_INVESTIGATOR
Department of Science and Technology-Food and Nutrition Research Institute (DOST-FNRI)
Locations
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Department of Science and Technology-Food and Nutrition Research Institute
City of Taguig, National Capital Region, Philippines
Countries
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Other Identifiers
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FIERC-2022-019
Identifier Type: -
Identifier Source: org_study_id
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