Clinical trial NCT05869305: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Sarcopenia
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2023-05-22
Enrollment: 45
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Muscle strength
timeFrame: 12 weeks
measure: Muscle mass
timeFrame: 12 weeks
measure: Physical performance
timeFrame: 12 weeks
measure: Sarcopenia score
timeFrame: 12 weeks
measure: Body weight
timeFrame: 12 weeks
measure: Body mass index
timeFrame: 12 weeks
Secondary outcomes:
measure: Nutritional status
timeFrame: 12 weeks
measure: Hungry feeling
timeFrame: 12 weeks
measure: Quality of life of the patient
timeFrame: 12 weeks
measure: Concentration of total protein in serum
timeFrame: 12 weeks
measure: Concentration of immunoglobulin in serum
timeFrame: 12 weeks
measure: Concentration of glucose in serum
timeFrame: 12 weeks
measure: Concentration of calcium in serum
timeFrame: 12 weeks
measure: Concentration of magnesium in serum
timeFrame: 12 weeks
measure: Concentration of sodium in serum
timeFrame: 12 weeks
measure: Concentration of creatinine in serum
timeFrame: 12 weeks
measure: Concentration of blood urea nitrogen in serum
timeFrame: 12 weeks
measure: Concentration of aspartate transaminase in serum
timeFrame: 12 weeks
measure: Concentration of alanine aminotransferase in serum
timeFrame: 12 weeks
measure: Concentration of alkaline phosphatase in serum
timeFrame: 12 weeks
measure: Skin reaction
timeFrame: 12 weeks
measure: Respiratory reaction
timeFrame: 12 weeks
measure: Gastrointestinal tract reaction
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
References: