Efficacy and Safety of Protein Product in Volunteers With Sarcopenia

Sarcopenia Clinical Trial

Official title:

Efficacy and Safety of Protein Product in Volunteers With Sarcopenia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05869305
• Other study ID #: IRBRTA 426/2566
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: March 20, 2024

Study information

• Verified date: May 2023
• Source: Chulalongkorn University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: March 20, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sarcopenia

Intervention

Dietary Supplement:
• whey protein isolate
Take 1 sachet/day for 12 weeks.
• isolated soy protein
Take 1 sachet/day for 12 weeks.
• placebo
Take 1 sachet/day for 12 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle strength	Using handgrip strength instrument (high value means high strength)	12 weeks
Primary	Muscle mass	Using Bioelectrical Impedance Analysis instrument (high value means high mass)	12 weeks
Primary	Physical performance	Using Gait speed (6-meter walk) (low time period and low score of tired mean high physical performance.	12 weeks
Primary	Sarcopenia score	Sarcopenia questionnaires (score 1 to 10 means low severity to high severity)	12 weeks
Primary	Body weight	Body weight of the patients	12 weeks
Primary	Body mass index	Body mass index of the patients	12 weeks
Secondary	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)	12 weeks
Secondary	Hungry feeling	Using visual analogue scale 0 to 10 (No hungry to very hungry)	12 weeks
Secondary	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)	12 weeks
Secondary	Concentration of total protein in serum	Measure concentration of total protein in serum	12 weeks
Secondary	Concentration of immunoglobulin in serum	Measure concentration of immunoglobulin in serum	12 weeks
Secondary	Concentration of glucose in serum	Measure concentration of glucose in serum	12 weeks
Secondary	Concentration of calcium in serum	Measure concentration of calcium in serum	12 weeks
Secondary	Concentration of magnesium in serum	Measure concentration of magnesium in serum	12 weeks
Secondary	Concentration of sodium in serum	Measure concentration of sodium in serum	12 weeks
Secondary	Concentration of creatinine in serum	Measure concentration of creatinine in serum	12 weeks
Secondary	Concentration of blood urea nitrogen in serum	Measure concentration of blood urea nitrogen in serum	12 weeks
Secondary	Concentration of aspartate transaminase in serum	Measure concentration of aspartate transaminase in serum	12 weeks
Secondary	Concentration of alanine aminotransferase in serum	Measure concentration of alanine aminotransferase in serum	12 weeks
Secondary	Concentration of alkaline phosphatase in serum	Measure concentration of alkaline phosphatase in serum	12 weeks
Secondary	Skin reaction	Found or not found	12 weeks
Secondary	Respiratory reaction	Found or not found	12 weeks
Secondary	Gastrointestinal tract reaction	Found or not found	12 weeks