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A Randomized Control Trial of Hinex Jelly on the Changes in Muscle Quality and Quantity

Primary Purpose

Nutrition, Healthy, Muscle Weakness, Elderly

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Hinex Jelly
Sponsored by
Kaohsiung Medical University Chung-Ho Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Nutrition, Healthy

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Adults over the age of 50 (include 50 years old). Can cooperate with the study. No surgical intervention within 3 months. Exclusion Criteria: Those who have obvious difficulty in movement (such as amputation) and cannot cooperate with the study. Those who are equipped with pacemakers or internal electronic medical devices. Pregnant women. Use of drugs or interventional therapy that may affect changes in body weight or muscle mass (such as other oral nutritional supplements, medicine, weight reduction medicine, bariatric gastric endoscopy therapy, bariatric surgery, acupuncture, acupuncture, electrical stimulation, etc.). Allergic to dairy or soy products.

Sites / Locations

  • Kaohsiung Medical University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Hinex Jelly Nutritional Supplement Intervention Group

Routine care group

Arm Description

Week 0th, Week 4th (14 days before and after), Week 8th (14 days before and after), Week 12th (14 days before and after), diet and exercise health education was given, with daily intervention of Hinex Jelly nutritional supplements 1 serving per day during 0th to 8th Week;

Week 0th, Week 4th (14 days before and after), Week 8th (14 days before and after), Week 12th (14 days before and after), the subjects were given regular dietary and exercise health education.

Outcomes

Primary Outcome Measures

Change from Baseline Appendicular skeletal muscle mass index at 8 weeks
Appendicular skeletal muscle mass index assessed using the Inbody S10
Change from Baseline handgrip strength at 8 weeks
assessed with a Jamar handheld dynamometer in kilograms
Change from Baseline performance on the 5-repetition sit-to-stand test at 8 weeks
assessed in seconds
Change from Baseline performance on 6-metre walk test at 8 weeks
assessed in seconds

Secondary Outcome Measures

Full Information

First Posted
June 5, 2023
Last Updated
July 9, 2023
Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05917353
Brief Title
A Randomized Control Trial of Hinex Jelly on the Changes in Muscle Quality and Quantity
Official Title
A Randomized Control Trial of Hinex Jelly on the Changes in Muscle Quality and Quantity
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Taiwan is about to enter a super-aged society in 2025. The health problems of the elderly are getting more and more attention. Among these geriatric issues, sarcopenia is an important issue. Sarcopenia is the culprit of disability in old age. It is characterized by persistent and general loss of skeletal muscle mass and function throughout the body, which may lead to disability, decreased quality of life, and even inability to take care of yourself and an increased risk of death. Human skeletal muscle decreases with age. After the age of 40, muscle mass will be lost at a rate of 8% per decade; after the age of 70, it will be lost at a faster rate of 15% per decade in average. Although all elderly will lose muscle mass due to aging, the degree and speed of loss vary from person to person. In addition to aging, it may also be caused by chronic diseases. Exercise intervention and nutritional intervention are the first choices for sarcopenia intervention. Regarding nutritional requirements, the elderly need at least 15 grams of essential amino acids per day for muscle building. Among them, leucine is the most important, which can increase protein production and reduce decomposition. Foods rich in leucine include soybeans, fish or beef. However, elderly people may not be able to get enough protein from their daily diet smoothly, often because of dysphagia, such as dental problems or chewing and swallowing problems. Therefore, oral nutritional supplements are relatively important for the improvement of muscle mass. Nutritional Supplement Hinex Jelly has 303 calories per serving, contains up to 15g of high-quality protein and a high amount of branched-chain amino acids, which is beneficial for muscle synthesis and tissue repair, plus a variety of minerals, vitamins, water-soluble dietary fiber, hydrolyzed collagen and other ingredients can strengthen nutritional supplements, maintain good health. In summary, this study intends to explore the effect of Hinex Jelly nutritional supplemental intervention on muscle mass quality and quantity changes by means of randomized intervention and controlled trials.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nutrition, Healthy, Muscle Weakness, Elderly

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hinex Jelly Nutritional Supplement Intervention Group
Arm Type
Experimental
Arm Description
Week 0th, Week 4th (14 days before and after), Week 8th (14 days before and after), Week 12th (14 days before and after), diet and exercise health education was given, with daily intervention of Hinex Jelly nutritional supplements 1 serving per day during 0th to 8th Week;
Arm Title
Routine care group
Arm Type
No Intervention
Arm Description
Week 0th, Week 4th (14 days before and after), Week 8th (14 days before and after), Week 12th (14 days before and after), the subjects were given regular dietary and exercise health education.
Intervention Type
Dietary Supplement
Intervention Name(s)
Hinex Jelly
Intervention Description
Name: Hinex Jelly Dosage form: Semi-solid jelly/ A-114001297-00000-2 Dose(s): 300g/pack (per serving) Dosing schedule: one pack (serving) per day Mechanism of action: Nutritional supplement semi-solid food (content 61-91g/100g, protein 4.0-6.0/100g, saturated fatty acid 0.72-1.08g/100g, carbohydrate 12.56-18.84g/100g, dietary fiber 1.0-1.4g/100g), It is used as a nutritional supplement food.
Primary Outcome Measure Information:
Title
Change from Baseline Appendicular skeletal muscle mass index at 8 weeks
Description
Appendicular skeletal muscle mass index assessed using the Inbody S10
Time Frame
8 weeks after the first session
Title
Change from Baseline handgrip strength at 8 weeks
Description
assessed with a Jamar handheld dynamometer in kilograms
Time Frame
8 weeks after the first session
Title
Change from Baseline performance on the 5-repetition sit-to-stand test at 8 weeks
Description
assessed in seconds
Time Frame
8 weeks after the first session
Title
Change from Baseline performance on 6-metre walk test at 8 weeks
Description
assessed in seconds
Time Frame
8 weeks after the first session

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Adults over the age of 50 (include 50 years old). Can cooperate with the study. No surgical intervention within 3 months. Exclusion Criteria: Those who have obvious difficulty in movement (such as amputation) and cannot cooperate with the study. Those who are equipped with pacemakers or internal electronic medical devices. Pregnant women. Use of drugs or interventional therapy that may affect changes in body weight or muscle mass (such as other oral nutritional supplements, medicine, weight reduction medicine, bariatric gastric endoscopy therapy, bariatric surgery, acupuncture, acupuncture, electrical stimulation, etc.). Allergic to dairy or soy products.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chen-Cheng Yang, MD
Phone
+886-7-803-6783
Ext
3460
Email
kmshhinexjelly@gmail.com
Facility Information:
Facility Name
Kaohsiung Medical University Hospital
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chen-Cheng Yang, MD
Phone
+886-7-803-6783
Ext
3460
Email
kmshhinexjelly@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Randomized Control Trial of Hinex Jelly on the Changes in Muscle Quality and Quantity

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