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NCT05869305 | Not yet recruiting | Sarcopenia

Efficacy and Safety of Protein Product in Volunteers With Sarcopenia
Sponsor:

Chulalongkorn University

Information provided by (Responsible Party):

Pornanong Aramwit, Pharm.D., Ph.D

Brief Summary:

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

Condition or disease

Sarcopenia

Intervention/treatment

whey protein isolate

isolated soy protein

placebo

Phase

Not Applicable

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 : Interventional
Estimated Enrollment : 45 participants
Masking : Quadruple
Primary Purpose : Supportive Care
Official Title : Efficacy and Safety of Protein Product in Volunteers With Sarcopenia
Actual Study Start Date : June 1, 2023
Estimated Primary Completion Date : February 1, 2024
Estimated Study Completion Date : March 20, 2024
Arm Intervention/treatment

Experimental: whey protein isolate group

Whey protein isolate is contained in the sachet.

Dietary Supplement: whey protein isolate

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

Experimental: placebo group

Base powder without proteins is contained in the sachet

Dietary Supplement: placebo
Ages Eligible for Study: 20 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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
Efficacy and Safety of Protein Product in Volunteers With Sarcopenia

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Efficacy and Safety of Protein Product in Volunteers With Sarcopenia

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