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

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

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Sarcopenia
• Intervention / Treatment: Dietary supplement: Nutrition supplementation; Other: Exercise

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.

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Philippines
  • Metro Manila
    • Taguig, Metro Manila, Philippines, 1631
      • Department of Science and Technology-Food and Nutrition Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Dietary supplement: 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.; Other Names: Protein drink; Other: 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 Names: Resistance and group exercise
Placebo Comparator: 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.	Dietary supplement: 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.; Other Names: Protein drink; Other: 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 Names: Resistance and group exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Food and Nutrition Research Institute, Philippines
• Collaborators: Wageningen University and Research
• Investigators: Principal Investigator: Robby Carlo A Tan, Msc, Department of Science and Technology-Food and Nutrition Research Institute (DOST-FNRI)

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2023
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 31, 2024

Study Registration Dates

• First Submitted: July 12, 2023
• First Submitted That Met QC Criteria: July 12, 2023
• First Posted (Actual): July 19, 2023

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Exercise; Body Composition; Sarcopenia; Protein; Functional Status
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Sarcopenia
• Other Study ID Numbers: FIERC-2022-019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No