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

NCT05926375 | Unknown

• 1 other identifier: N202112052
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcopenia

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• short physical performance battery

  week 0,8,12,20

• 6-meter gait speed

  week 0,8,12,20

• Mini nutritional assessment

  week 0,8,12,20

Other Outcomes (8)

• General clinical chemistry of blood lipid

  week 0,8,12,20

• General clinical chemistry of blood sugar

  week 0,8,12,20

• General clinical chemistry of liver function

  week 0,8,12,20

Study Arms (2)

first intervention group (Supp-Con sequence)

EXPERIMENTAL

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)

post intervention group (Con-Supp sequence)

EXPERIMENTAL

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)

Interventions

HINEX Jelly ( jelly high protein supplement) 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.

first intervention group (Supp-Con sequence); post intervention group (Con-Supp sequence)

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei Medical University: lead
• Taiwan Otsuka Pharm. Co., Ltd: collaborator

Study Sites (1)

Taipei Medical University

New Taipei City, Zhonghe Dist., 235, Taiwan

Location

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Jane C-J Chao, Ph.D.

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 19, 2023
• First Posted: July 3, 2023
• Study Start: January 5, 2022
• Primary Completion: March 24, 2023
• Study Completion: June 28, 2023
• Last Updated: July 3, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)