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

Primary Purpose

Sarcopenia

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Philippines
Study Type
Interventional
Intervention
Nutrition supplementation
Exercise
Sponsored by
Food and Nutrition Research Institute, Philippines
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sarcopenia focused on measuring Sarcopenia, Body Composition, Protein, Exercise, Functional Status

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Science and Technology-Food and Nutrition Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Intervention Group

Placebo Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
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.
Change in physical performance, as measured by timed up-and-go test
Faster time duration to complete the test indicate lesser risk for falls
Change in physical performance, as measured by short physical performance battery
Score ranges from 0 to 12 with a higher score indicating better functionality
Change in physical performance, as measured by 10-meter walk test
Faster walking speed (in meters per second) indicate better functionality

Secondary Outcome Measures

Full Information

First Posted
July 12, 2023
Last Updated
August 22, 2023
Sponsor
Food and Nutrition Research Institute, Philippines
Collaborators
Wageningen University and Research
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1. Study Identification

Unique Protocol Identification Number
NCT05953116
Brief Title
Managing the Nutritional Needs of Older Filipino With Due Attention to Protein Nutrition and Functional Health Study
Acronym
MANO PO
Official Title
Managing the Nutritional Needs of Older Filipino With Due Attention to Protein Nutrition and Functional Health (Mano Po) Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 4, 2023 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Food and Nutrition Research Institute, Philippines
Collaborators
Wageningen University and Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia
Keywords
Sarcopenia, Body Composition, Protein, Exercise, Functional Status

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
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.
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Nutrition supplementation
Other Intervention Name(s)
Protein drink
Intervention Description
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
Other
Intervention Name(s)
Exercise
Other Intervention Name(s)
Resistance and group exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in muscle mass, as measured by dual-energy x-ray absorptiometry (DXA)
Description
Measurement of appendicular skeletal muscle mass index (ASMI) by dividing total muscle mass (kg) of appendages with height in meters squared
Time Frame
Baseline, Midline (6 weeks), Endline (12 weeks)
Title
Change in muscle strength, as measured by grip strength and leg strength (Jamar, MicroFET)
Description
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.
Time Frame
Baseline, Midline (6 weeks), Endline (12 weeks)
Title
Change in physical performance, as measured by timed up-and-go test
Description
Faster time duration to complete the test indicate lesser risk for falls
Time Frame
Baseline, Midline (6 weeks), Endline (12 weeks)
Title
Change in physical performance, as measured by short physical performance battery
Description
Score ranges from 0 to 12 with a higher score indicating better functionality
Time Frame
Baseline, Midline (6 weeks), Endline (12 weeks)
Title
Change in physical performance, as measured by 10-meter walk test
Description
Faster walking speed (in meters per second) indicate better functionality
Time Frame
Baseline, Midline (6 weeks), Endline (12 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robby Carlo A Tan, Msc
Organizational Affiliation
Department of Science and Technology-Food and Nutrition Research Institute (DOST-FNRI)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Science and Technology-Food and Nutrition Research Institute
City
Taguig
State/Province
Metro Manila
ZIP/Postal Code
1631
Country
Philippines

12. IPD Sharing Statement

Plan to Share IPD
No

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

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