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

Sarcopenia Clinical Trial

— ManoPo  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05953116
• Other study ID #: FIERC-2022-019
• Status: Enrolling by invitation
• Phase: N/A
• Start date: September 4, 2023
• Est. completion date: August 31, 2024

Study information

• Verified date: February 2024
• Source: Food and Nutrition Research Institute, Philippines
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 72
• Est. completion date: August 31, 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sarcopenia

Intervention

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:
• 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.

Locations

Country	Name	City	State
Philippines	Department of Science and Technology-Food and Nutrition Research Institute	Taguig	Metro Manila

Sponsors (2)

Lead Sponsor	Collaborator
Food and Nutrition Research Institute, Philippines	Wageningen University and Research

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)