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Efficacy and Safety of Protein Product in Volunteers With Sarcopenia

Primary Purpose

Sarcopenia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
whey protein isolate
isolated soy protein
placebo
Sponsored by
Chulalongkorn University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Sarcopenia

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    whey protein isolate group

    isolated soy protein group

    placebo group

    Arm Description

    Whey protein isolate is contained in the sachet.

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

    Base powder without proteins is contained in the sachet

    Outcomes

    Primary Outcome Measures

    Muscle strength
    Using handgrip strength instrument (high value means high strength)
    Muscle mass
    Using Bioelectrical Impedance Analysis instrument (high value means high mass)
    Physical performance
    Using Gait speed (6-meter walk) (low time period and low score of tired mean high physical performance.
    Sarcopenia score
    Sarcopenia questionnaires (score 1 to 10 means low severity to high severity)
    Body weight
    Body weight of the patients
    Body mass index
    Body mass index of the patients

    Secondary Outcome Measures

    Nutritional status
    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)
    Hungry feeling
    Using visual analogue scale 0 to 10 (No hungry to very hungry)
    Quality of life of the patient
    36-Item Short Form Survey questionnaires shows in quality of life score 0 to 100 (High score means a better outcome)
    Concentration of total protein in serum
    Measure concentration of total protein in serum
    Concentration of immunoglobulin in serum
    Measure concentration of immunoglobulin in serum
    Concentration of glucose in serum
    Measure concentration of glucose in serum
    Concentration of calcium in serum
    Measure concentration of calcium in serum
    Concentration of magnesium in serum
    Measure concentration of magnesium in serum
    Concentration of sodium in serum
    Measure concentration of sodium in serum
    Concentration of creatinine in serum
    Measure concentration of creatinine in serum
    Concentration of blood urea nitrogen in serum
    Measure concentration of blood urea nitrogen in serum
    Concentration of aspartate transaminase in serum
    Measure concentration of aspartate transaminase in serum
    Concentration of alanine aminotransferase in serum
    Measure concentration of alanine aminotransferase in serum
    Concentration of alkaline phosphatase in serum
    Measure concentration of alkaline phosphatase in serum
    Skin reaction
    Found or not found
    Respiratory reaction
    Found or not found
    Gastrointestinal tract reaction
    Found or not found

    Full Information

    First Posted
    May 11, 2023
    Last Updated
    May 22, 2023
    Sponsor
    Chulalongkorn University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05869305
    Brief Title
    Efficacy and Safety of Protein Product in Volunteers With Sarcopenia
    Official Title
    Efficacy and Safety of Protein Product in Volunteers With Sarcopenia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 1, 2023 (Anticipated)
    Primary Completion Date
    February 1, 2024 (Anticipated)
    Study Completion Date
    March 20, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Chulalongkorn University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sarcopenia

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    45 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    whey protein isolate group
    Arm Type
    Experimental
    Arm Description
    Whey protein isolate is contained in the sachet.
    Arm Title
    isolated soy protein group
    Arm Type
    Experimental
    Arm Description
    Isolated soy protein, pea protein isolate, and brown rice protein are contained in the sachet.
    Arm Title
    placebo group
    Arm Type
    Experimental
    Arm Description
    Base powder without proteins is contained in the sachet
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    whey protein isolate
    Intervention Description
    Take 1 sachet/day for 12 weeks.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    isolated soy protein
    Intervention Description
    Take 1 sachet/day for 12 weeks.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    placebo
    Intervention Description
    Take 1 sachet/day for 12 weeks.
    Primary Outcome Measure Information:
    Title
    Muscle strength
    Description
    Using handgrip strength instrument (high value means high strength)
    Time Frame
    12 weeks
    Title
    Muscle mass
    Description
    Using Bioelectrical Impedance Analysis instrument (high value means high mass)
    Time Frame
    12 weeks
    Title
    Physical performance
    Description
    Using Gait speed (6-meter walk) (low time period and low score of tired mean high physical performance.
    Time Frame
    12 weeks
    Title
    Sarcopenia score
    Description
    Sarcopenia questionnaires (score 1 to 10 means low severity to high severity)
    Time Frame
    12 weeks
    Title
    Body weight
    Description
    Body weight of the patients
    Time Frame
    12 weeks
    Title
    Body mass index
    Description
    Body mass index of the patients
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    Nutritional status
    Description
    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)
    Time Frame
    12 weeks
    Title
    Hungry feeling
    Description
    Using visual analogue scale 0 to 10 (No hungry to very hungry)
    Time Frame
    12 weeks
    Title
    Quality of life of the patient
    Description
    36-Item Short Form Survey questionnaires shows in quality of life score 0 to 100 (High score means a better outcome)
    Time Frame
    12 weeks
    Title
    Concentration of total protein in serum
    Description
    Measure concentration of total protein in serum
    Time Frame
    12 weeks
    Title
    Concentration of immunoglobulin in serum
    Description
    Measure concentration of immunoglobulin in serum
    Time Frame
    12 weeks
    Title
    Concentration of glucose in serum
    Description
    Measure concentration of glucose in serum
    Time Frame
    12 weeks
    Title
    Concentration of calcium in serum
    Description
    Measure concentration of calcium in serum
    Time Frame
    12 weeks
    Title
    Concentration of magnesium in serum
    Description
    Measure concentration of magnesium in serum
    Time Frame
    12 weeks
    Title
    Concentration of sodium in serum
    Description
    Measure concentration of sodium in serum
    Time Frame
    12 weeks
    Title
    Concentration of creatinine in serum
    Description
    Measure concentration of creatinine in serum
    Time Frame
    12 weeks
    Title
    Concentration of blood urea nitrogen in serum
    Description
    Measure concentration of blood urea nitrogen in serum
    Time Frame
    12 weeks
    Title
    Concentration of aspartate transaminase in serum
    Description
    Measure concentration of aspartate transaminase in serum
    Time Frame
    12 weeks
    Title
    Concentration of alanine aminotransferase in serum
    Description
    Measure concentration of alanine aminotransferase in serum
    Time Frame
    12 weeks
    Title
    Concentration of alkaline phosphatase in serum
    Description
    Measure concentration of alkaline phosphatase in serum
    Time Frame
    12 weeks
    Title
    Skin reaction
    Description
    Found or not found
    Time Frame
    12 weeks
    Title
    Respiratory reaction
    Description
    Found or not found
    Time Frame
    12 weeks
    Title
    Gastrointestinal tract reaction
    Description
    Found or not found
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Learn more about this trial

    Efficacy and Safety of Protein Product in Volunteers With Sarcopenia

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