Clinical trial NCT05926375: Effect of HINEX Jelly on Nutritional Status in People With Possible Sarcopenia or Sarcopenia
Official title: Effect of HINEX Jelly on Nutritional Status in People With Possible Sarcopenia or Sarcopenia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sarcopenia
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
Collaborators: name: Taiwan Otsuka Pharm. Co., Ltd
First posted: 2023-07-03
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The experiment lasted for 20 weeks, including 8 weeks self-controlled phase, 8 weeks supplement phase and 4 weeks washout period. In self-controlled phase would intake 400\~500 kcal breakfast and in supplement phase consume one servings of jelly high protein supplement with 100\~200 kcal food at breakfast. Subjects were randomly divided into "first intervention group" and "post intervention group". The first intervention group used HINEX Jelly as daily breakfast during the first to 8th weeks of the experiment, the 9th to 12th week is the wash out period, the 13th to the 20th week is the selfcontrol period; the post-intervention group is in the first to the 8th week of self-control period,the 9th to 12th week is the wash out period, and the 13th to the 20th week is used HINEX Jelly as daily breakfast, as well as maintained their regular diet and medication, but do exercise lifestyle modification during 20-week experimental period.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: muscle mass
timeFrame: week 0,8,12,20
measure: hand grip strength
timeFrame: week 0,8,12,20
measure: 5-time chair stand test
timeFrame: week 0,8,12,20
Secondary outcomes:
measure: short physical performance battery
timeFrame: week 0,8,12,20
measure: 6-meter gait speed
timeFrame: week 0,8,12,20
measure: Mini nutritional assessment
timeFrame: week 0,8,12,20
Other outcomes:
measure: General clinical chemistry of blood lipid
timeFrame: week 0,8,12,20
measure: General clinical chemistry of blood sugar
timeFrame: week 0,8,12,20
measure: General clinical chemistry of liver function
timeFrame: week 0,8,12,20
measure: General clinical chemistry of kidney function
timeFrame: week 0,8,12,20
measure: General clinical chemistry of nutritional status
timeFrame: week 0,8,12,20
measure: General clinical chemistry of vitamin D status
timeFrame: week 0,8,12,20
measure: C-reactive protein (CRP)
timeFrame: week 0,8,12,20
measure: Tumor Necrosis Factor-α(TNF-α)
timeFrame: week 0,8,12,20
Locations:
city: New Taipei City
country: Taiwan
facility: Taipei Medical University
state: Zhonghe Dist.
Study officials:
affiliation: Taipei Medical University, Taiwan, R.O.C.
name: Jane C-J Chao, Ph.D.
role: STUDY_CHAIR
References: