Effect of HINEX Jelly on Nutritional Status in People With Possible Sarcopenia or Sarcopenia

Sarcopenia Clinical Trial

Official title:

Effect of HINEX Jelly on Nutritional Status in People With Possible Sarcopenia or Sarcopenia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05926375
• Other study ID #: N202112052
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 5, 2022
• Est. completion date: June 28, 2023

Study information

• Verified date: January 2023
• Source: Taipei Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

HINEX Jelly is a jelly high protein supplement. This report is to investigate whether jelly high protein supplement can achieve greater muscle mass, muscle strength, physical performance and nutritional status in sarcopenia or possible sarcopenia subjects. It is 20 weeks randomized, crossover, self-controlled trials. The screening, recruitment and trial period were carried out from Feb, 2022 to Mar, 2023. Patients were randomized to either a self-controlled phase,which intake 400~500 kcal breakfast, or a supplement phase consume one servings of jelly high protein supplement (303 kcal, 15 g protein and 2400 mg BCAA per serving) and 100~200 kcal food at breakfast per day, for 8 weeks. After a 4-week washout they cross over to the alternate treatment. The anthropometric measurements, sarcopenia parameters, nutritional assessment and hematology assessment data were measured at the week 0,8,12,20 and 24-hour dietary record were recorded at week 1,8,13,20.

Description:

Parameters of sarcopenia, including the muscle mass assessment, handgrip strength and physical performance assessment.Muscle mass and body composition were measured by bioelectrical impedance analysis (BIA). A hand dynamometer was used to measure handgrip strength. Physical performance was measured by short physical performance battery (SPPB), 6-meter gait speed and 5-time chair stand test. Mini nutritional assessment (MNA) used to measure nutritional status. The hematology assessment including total protein, albumin, pre-albumin, transferrin, c-reactive protein (CRP), vitamin D, calcium, glucose, insulin, homeostasis model assessment-estimated insulin resistance (HOMA-IR), total cholesterol, triacylglycerol, creatinine, creatine-kinase, alkaline phosphatase, glutamic oxaloacetic transaminase (GOT), glutamic pyruvic transaminase (GPT) and complete blood count.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: June 28, 2023
• Est. primary completion date: March 24, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

Inclusion Criteria:

• 40-85 years old, middle-aged and elderly subjects with possible sarcopenia or sarcopenia. According to AWGS 2019, possible sarcopenia is defined as (1) handgrip strength < 28 kg in men and < 18 kg in women or (2) 5-time chair stand test = 12 seconds; sarcopenia is defined as meet (1) or (2) plus appendicular skeletal muscle mass index (ASMI) < 7.0 kg/m2 in men and < 5.7 kg/m2 in women.

Exclusion Criteria:

• BMI>35 kg/m2, Taking any special diet (i.e. vegan), be allergic to ingredient (i.e. milk or soy bean) and any seriously acute or chronic lung, liver, kidney, gastrointestinal, cancers diseases history.

Related Conditions & MeSH terms

• Sarcopenia

Intervention

Dietary Supplement:
• HINEX Jelly ( jelly high protein supplement)
In self-controlled phase,which intake 400~500 kcal breakfast, or in supplement phase consume one servings of jelly high protein supplement (303 kcal, 15 g protein and 2400 mg BCAA per serving) and 100~200 kcal food at breakfast per day, for 8 weeks.

Locations

Country	Name	City	State
Taiwan	Taipei Medical University	New Taipei City	Zhonghe Dist.

Sponsors (2)

Lead Sponsor	Collaborator
Taipei Medical University	Taiwan Otsuka Pharm. Co., Ltd

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	General clinical chemistry of blood lipid	the change of lipid profile (total cholesterol and triglyceride) and measured via automated clinical chemistry analyzer	week 0,8,12,20
Other	General clinical chemistry of blood sugar	the change of blood sugar (glucose, insulin) and measured via automated clinical chemistry analyzer. Use the glucose, insulin concentration to calculate homeostasis model assessment-estimated insulin resistance (HOMA-IR).	week 0,8,12,20
Other	General clinical chemistry of liver function	the change of liver function function ( glutamic oxaloacetic transaminase (GOT), glutamic pyruvic transaminase (GPT)) and measured via automated clinical chemistry analyzer	week 0,8,12,20
Other	General clinical chemistry of kidney function	the change of liver function and kidney function (creatinine) and measured via automated clinical chemistry analyzer	week 0,8,12,20
Other	General clinical chemistry of nutritional status	the change of nutritional status (total protein in g/dL, albumin in g/dL, pre-albumin in mg/dL, transferrin in mg/dL) and measured via automated clinical chemistry analyzer	week 0,8,12,20
Other	General clinical chemistry of vitamin D status	the change of vitamin D status and measured via automated clinical chemistry analyzer	week 0,8,12,20
Other	C-reactive protein (CRP)	the change of inflammatory marker C-reactive protein (CRP) measured via automated clinical chemistry analyzer	week 0,8,12,20
Other	Tumor Necrosis Factor-a(TNF-a)	the change of inflammatory marker Tumor Necrosis Factor-a(TNF-a) measured via commercial kit	week 0,8,12,20
Primary	muscle mass	the change of muscle mass and measured via bioelectrical impedance analysis(BIA)	week 0,8,12,20
Primary	hand grip strength	the change of hand grip strength as the marker of muscle strength.Measured via hand grip dynamometry.	week 0,8,12,20
Primary	5-time chair stand test	the change of 5-time chair stand test as the marker of physical performance.	week 0,8,12,20
Secondary	short physical performance battery	the change of short physical performance battery as the marker of physical performance.	week 0,8,12,20
Secondary	6-meter gait speed	the change of 6-meter gait speed as the marker of physical performance.	week 0,8,12,20
Secondary	Mini nutritional assessment	the change of 6-meter gait speed as the marker of nutritional status.	week 0,8,12,20