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

NCT05926375 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-07-03

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Taiwan Otsuka Pharm. Co., Ltd

    collaborator INDUSTRY

  • Taipei Medical University

    lead OTHER

Principal Investigators

  • Jane C-J Chao, Ph.D. · Taipei Medical University, Taiwan, R.O.C.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-05
Primary Completion
2023-03-24
Completion
2023-06-28

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05926375 on ClinicalTrials.gov