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

NCT ID: NCT05926375

Last Updated: 2023-07-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-05
• Study Completion Date: 2023-06-28

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.

Conditions

Sarcopenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

HINEX Jelly ( jelly high protein supplement)

Intervention Type: DIETARY_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.

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.

Group Type: EXPERIMENTAL

HINEX Jelly ( jelly high protein supplement)

Intervention Type: DIETARY_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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Taiwan Otsuka Pharm. Co., Ltd

INDUSTRY

Sponsor Role: collaborator

Taipei Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jane C-J Chao, Ph.D.

Role: STUDY_CHAIR

Taipei Medical University, Taiwan, R.O.C.

Locations

Taipei Medical University

New Taipei City, Zhonghe Dist., Taiwan

Countries

Taiwan

Other Identifiers

N202112052

Identifier Type: -

Identifier Source: org_study_id