Ignite Creation Date:
2024-05-06 @ 7:12 PM
Last Modification Date:
2024-10-26 @ 3:02 PM
Study NCT ID:
NCT05926375
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-07-03
First Post:
2023-06-19
Brief Title:
Effect of HINEX Jelly on Nutritional Status in People With Possible Sarcopenia or Sarcopenia
Sponsor:
Taipei Medical University
Organization:
Taipei Medical University
Study Overview
Official Title:
Effect of HINEX Jelly on Nutritional Status in People With Possible Sarcopenia or Sarcopenia
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 phasewhich intake 400500 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 100200 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 081220 and 24-hour dietary record were recorded at week 181320
Detailed Description:
Parameters of sarcopenia including the muscle mass assessment handgrip strength and physical performance assessmentMuscle 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None