Efficacy and Safety of Protein Product in Volunteers With Sarcopenia

May 22, 2023 updated by: Pornanong Aramwit, Pharm.D., Ph.D, Chulalongkorn University
The objective of this study are to evaluate efficacy and safety of protein product in volunteers with sarcopenia.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: whey protein isolate group
Whey protein isolate is contained in the sachet.
Dietary supplement: whey protein isolate
Take 1 sachet/day for 12 weeks.
Experimental: isolated soy protein group
Isolated soy protein, pea protein isolate, and brown rice protein are contained in the sachet.
Dietary supplement: isolated soy protein
Take 1 sachet/day for 12 weeks.
Experimental: placebo group
Base powder without proteins is contained in the sachet
Dietary supplement: placebo
Take 1 sachet/day for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Muscle strength
Time Frame: 12 weeks
Using handgrip strength instrument (high value means high strength)
12 weeks
Muscle mass
Time Frame: 12 weeks
Using Bioelectrical Impedance Analysis instrument (high value means high mass)
12 weeks
Physical performance
Time Frame: 12 weeks
Using Gait speed (6-meter walk) (low time period and low score of tired mean high physical performance.
12 weeks
Sarcopenia score
Time Frame: 12 weeks
Sarcopenia questionnaires (score 1 to 10 means low severity to high severity)
12 weeks
Body weight
Time Frame: 12 weeks
Body weight of the patients
12 weeks
Body mass index
Time Frame: 12 weeks
Body mass index of the patients
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Nutritional status
Time Frame: 12 weeks
Nutritional score (score 0 to 17 means lack of nutrition, score 17 to 23.5 means risk to have lack of nutrition, score 24 to 30 means normal nutrition)
12 weeks
Hungry feeling
Time Frame: 12 weeks
Using visual analogue scale 0 to 10 (No hungry to very hungry)
12 weeks
Skin reaction
Time Frame: 12 weeks
Found or not found
12 weeks
Respiratory reaction
Time Frame: 12 weeks
Found or not found
12 weeks
Gastrointestinal tract reaction
Time Frame: 12 weeks
Found or not found
12 weeks
Quality of life of the patient
Time Frame: 12 weeks
36-Item Short Form Survey questionnaires shows in quality of life score 0 to 100 (High score means a better outcome)
12 weeks
Concentration of total protein in serum
Time Frame: 12 weeks
Measure concentration of total protein in serum
12 weeks
Concentration of immunoglobulin in serum
Time Frame: 12 weeks
Measure concentration of immunoglobulin in serum
12 weeks
Concentration of glucose in serum
Time Frame: 12 weeks
Measure concentration of glucose in serum
12 weeks
Concentration of calcium in serum
Time Frame: 12 weeks
Measure concentration of calcium in serum
12 weeks
Concentration of magnesium in serum
Time Frame: 12 weeks
Measure concentration of magnesium in serum
12 weeks
Concentration of sodium in serum
Time Frame: 12 weeks
Measure concentration of sodium in serum
12 weeks
Concentration of creatinine in serum
Time Frame: 12 weeks
Measure concentration of creatinine in serum
12 weeks
Concentration of blood urea nitrogen in serum
Time Frame: 12 weeks
Measure concentration of blood urea nitrogen in serum
12 weeks
Concentration of aspartate transaminase in serum
Time Frame: 12 weeks
Measure concentration of aspartate transaminase in serum
12 weeks
Concentration of alanine aminotransferase in serum
Time Frame: 12 weeks
Measure concentration of alanine aminotransferase in serum
12 weeks
Concentration of alkaline phosphatase in serum
Time Frame: 12 weeks
Measure concentration of alkaline phosphatase in serum
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chulalongkorn University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2023

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 20, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 11, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 22, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 24, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRBRTA 426/2566

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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