Efficacy and Safety of Protein Product in Volunteers With Sarcopenia

NCT ID: NCT05869305

Last Updated: 2023-05-24

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2024-03-20

Brief Summary

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The objective of this study are to evaluate efficacy and safety of protein product in volunteers with sarcopenia.

Detailed Description

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There are 45 patients in this study. They are randomly divided into 3 groups which are whey protein isolate group, isolated soy protein group, placebo group. They will take the sample 1 sachet/day for 12 weeks. Muscle strength, muscle mass, physical performance, sarcopenia score, body weight, body mass index, protein, immunoglobulins, quality of life, liver function, kidney function, other laboratory value, and adverse effects are evaluated.

Conditions

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Sarcopenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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whey protein isolate group

Whey protein isolate is contained in the sachet.

Group Type EXPERIMENTAL

whey protein isolate

Intervention Type DIETARY_SUPPLEMENT

Take 1 sachet/day for 12 weeks.

isolated soy protein group

Isolated soy protein, pea protein isolate, and brown rice protein are contained in the sachet.

Group Type EXPERIMENTAL

isolated soy protein

Intervention Type DIETARY_SUPPLEMENT

Take 1 sachet/day for 12 weeks.

placebo group

Base powder without proteins is contained in the sachet

Group Type EXPERIMENTAL

placebo

Intervention Type DIETARY_SUPPLEMENT

Take 1 sachet/day for 12 weeks.

Interventions

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whey protein isolate

Take 1 sachet/day for 12 weeks.

Intervention Type DIETARY_SUPPLEMENT

isolated soy protein

Take 1 sachet/day for 12 weeks.

Intervention Type DIETARY_SUPPLEMENT

placebo

Take 1 sachet/day for 12 weeks.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Age more than 20 years
* Sarcopenia score more than 4
* Handgrip strength less than 28 kg in male and less than 18 kg in female and muscle mass less than 7 kg/m2 in male and less than 5.7 kg/m2 in female or Gait speed (6-meter walk) less than 1 m/s
* Can take protein from animal
* Can read and write or have people to look after
* Willing to participate in this study

Exclusion Criteria

* Allergic to protein from animals and plants
* Hepatitis or cirrhosis
* Glomerular disease or glomerular filtration rate less than 60 ml/min/1.73m2
* Cancer or heart disease
* Cannot walk
* Pregnancy and lactation
* Duodenal surgery
* Take protein supplement within 2 weeks
* Take protein in normal food more than 1.2 g/body weight/day
* Participating in other studies
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chulalongkorn University

OTHER

Sponsor Role lead

Responsible Party

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Pornanong Aramwit, Pharm.D., Ph.D

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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IRBRTA 426/2566

Identifier Type: -

Identifier Source: org_study_id

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