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

Sponsor

Food and Nutrition Research Institute, Philippines (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05953116

Collaborator

Wageningen University and Research (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

5.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Sarcopenia	Dietary Supplement: Nutrition supplementation Other: Exercise	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

72 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

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.

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Aug 31, 2024

Arms and Interventions

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

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

Other Names:

Protein drink

Other: Exercise

Other Names:

Resistance and group exercise

Outcome Measures

Primary Outcome Measures

Change in muscle mass, as measured by dual-energy x-ray absorptiometry (DXA) [Baseline, Midline (6 weeks), Endline (12 weeks)]
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) [Baseline, Midline (6 weeks), Endline (12 weeks)]
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 [Baseline, Midline (6 weeks), Endline (12 weeks)]
Faster time duration to complete the test indicate lesser risk for falls
Change in physical performance, as measured by short physical performance battery [Baseline, Midline (6 weeks), Endline (12 weeks)]
Score ranges from 0 to 12 with a higher score indicating better functionality
Change in physical performance, as measured by 10-meter walk test [Baseline, Midline (6 weeks), Endline (12 weeks)]
Faster walking speed (in meters per second) indicate better functionality

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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