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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Sarcopenia
• Intervention / Treatment: Dietary supplement: HINEX Jelly ( jelly high protein supplement)

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Zhonghe Dist.
    • New Taipei City, Zhonghe Dist., Taiwan, 235
      • Taipei Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: first intervention group (Supp-Con sequence); 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.	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.
Experimental: post intervention group (Con-Supp sequence); 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
muscle mass	the change of muscle mass and measured via bioelectrical impedance analysis(BIA)	week 0,8,12,20
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
short physical performance battery	the change of short physical performance battery as the marker of physical performance.	week 0,8,12,20
6-meter gait speed	the change of 6-meter gait speed as the marker of physical performance.	week 0,8,12,20
Mini nutritional assessment	the change of 6-meter gait speed as the marker of nutritional status.	week 0,8,12,20

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
C-reactive protein (CRP)	the change of inflammatory marker C-reactive protein (CRP) measured via automated clinical chemistry analyzer	week 0,8,12,20
Tumor Necrosis Factor-α(TNF-α)	the change of inflammatory marker Tumor Necrosis Factor-α(TNF-α) measured via commercial kit	week 0,8,12,20

Collaborators and Investigators

• Sponsor: Taipei Medical University
• Collaborators: Taiwan Otsuka Pharm. Co., Ltd
• Investigators: Study Chair: Jane C-J Chao, Ph.D., Taipei Medical University, Taiwan, R.O.C.

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2022
• Primary Completion (Actual): March 24, 2023
• Study Completion (Estimated): June 28, 2023

Study Registration Dates

• First Submitted: June 19, 2023
• First Submitted That Met QC Criteria: June 28, 2023
• First Posted (Actual): July 3, 2023

Study Record Updates

• Last Update Posted (Actual): July 3, 2023
• Last Update Submitted That Met QC Criteria: June 28, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Sarcopenia
• Other Study ID Numbers: N202112052

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No