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Pennisetum Purpureum in Sarcopenia Patients

Primary Purpose

Sarcopenia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Pennisetum purpureum
Placebo
Sponsored by
Taipei Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcopenia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: adult between 18-75 years old skeletal muscle mass in extremities by dual-energy X-ray absorptiometry less than 7.0 kg/m2 in men and less than 5.4 kg/m2 in women one of the following criteria were met: (1) handgrip strength less than 28 kg in men and less than 18 kg in women and (2) 5-time chair stand test over than 12 seconds Exclusion Criteria: The volunteers have history of cardiovascular, liver, kidney, and diabetes mellitus acute sport injury participated in any clinical trials or experimental research in the last 3 months before our experiment taking supplement during the experimental period did not maintain their regular eating habit or drink alcohol

Sites / Locations

  • Taipei Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Pennisetum purpureum group

Placebo group

Arm Description

Outcomes

Primary Outcome Measures

Body height
Body height
Body height
Body weight
Body weight
Body weight
BMI (body mass index)
BMI (body mass index)
BMI (body mass index)
Systolic blood pressure
Systolic blood pressure
Systolic blood pressure
Diastolic blood pressure
Diastolic blood pressure
Diastolic blood pressure
ASM (Appendicular Skeletal Muscle Mass)
ASM (Appendicular Skeletal Muscle Mass)
Upper Arm Circumference
Upper Arm Circumference
Upper Arm Circumference
Thigh Circumference
Thigh Circumference
Thigh Circumference
Grip Strength
Grip Strength
Grip Strength
10-Meter Walk Test
10-Meter Walk Test
10-Meter Walk Test
Testosterone level
Testosterone level
Testosterone level
Cortisol level
Cortisol level
Cortisol level
Growth Hormone level
Growth Hormone level
Growth Hormone level
Insulin-like Growth Factor-1
Insulin-like Growth Factor-1
Insulin-like Growth Factor-1
follistain level
follistain level
follistain level
myostain level
myostain level
myostain level

Secondary Outcome Measures

Full Information

First Posted
May 26, 2023
Last Updated
August 8, 2023
Sponsor
Taipei Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05911516
Brief Title
Pennisetum Purpureum in Sarcopenia Patients
Official Title
Effects of Pennisetum Purpureum Health Food Supplementation on Muscle Mass and Muscle Strength
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Medical University

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
The purpose of this study was to investigate the effects of Pennisetum purpureum health food supplementation on muscle mass and muscle strength.
Detailed Description
All participants performed anthropometric measurements (body height, body weight, BMI, blood pressure, body composition, upper arm circumference, and lower thigh circumference), blood collection (hormones, liver function, and kidney function), exercise test (grip strength and 10-m walking test), as well as questionnaire survey before supplementation. Participants were assigned to either the experimental (n=20) or placebo (n=20) group according to their body composition, upper arm circumference, and lower thigh circumference. The definition of insufficient muscle mass was based on the Asian working group for sarcopenia (AWGS) that skeletal muscle mass in extremities by dual-energy X-ray absorptiometry less than 7.0 kg/m2 in men and less than 5.4 kg/m2 in women is a necessary condition, and one of the following criteria were met: (1) handgrip strength less than 28 kg in men and less than 18 kg in women and (2) 5-time chair stand test over than12 seconds. The anthropometric measurements (body height, body weight, BMI, blood pressure, body composition, upper arm circumference, and lower thigh circumference), blood collection (hormones, liver function, and kidney function), exercise test (grip strength and 10-m walking test), as well as questionnaire survey, were collected after 8 weeks and 12 weeks of supplementation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants were assigned to either the experimental (n=20) or placebo (n=20) group according to their body composition, upper arm circumference, and lower thigh circumference.
Masking
ParticipantInvestigator
Masking Description
A double-blind, matched-pair study design
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pennisetum purpureum group
Arm Type
Experimental
Arm Title
Placebo group
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Pennisetum purpureum
Intervention Description
300mg Participants received 900mg of Pennisetum purpureum orally daily for 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Body height
Time Frame
Baseline (before supplementation)
Title
Body height
Time Frame
8 weeks of supplementation
Title
Body height
Time Frame
12 weeks of supplementation
Title
Body weight
Time Frame
Baseline (before supplementation)
Title
Body weight
Time Frame
8 weeks of supplementation
Title
Body weight
Time Frame
12 weeks of supplementation
Title
BMI (body mass index)
Time Frame
Baseline (before supplementation)
Title
BMI (body mass index)
Time Frame
8 weeks of supplementation
Title
BMI (body mass index)
Time Frame
12 weeks of supplementation
Title
Systolic blood pressure
Time Frame
Baseline (before supplementation)
Title
Systolic blood pressure
Time Frame
8 weeks of supplementation
Title
Systolic blood pressure
Time Frame
12 weeks of supplementation
Title
Diastolic blood pressure
Time Frame
Baseline (before supplementation)
Title
Diastolic blood pressure
Time Frame
8 weeks of supplementation
Title
Diastolic blood pressure
Time Frame
12 weeks of supplementation
Title
ASM (Appendicular Skeletal Muscle Mass)
Time Frame
12 weeks of supplementation
Title
ASM (Appendicular Skeletal Muscle Mass)
Time Frame
8 weeks of supplementation
Title
Upper Arm Circumference
Time Frame
Baseline (before supplementation)
Title
Upper Arm Circumference
Time Frame
8 weeks of supplementation
Title
Upper Arm Circumference
Time Frame
12 weeks of supplementation
Title
Thigh Circumference
Time Frame
Baseline (before supplementation)
Title
Thigh Circumference
Time Frame
8 weeks of supplementation
Title
Thigh Circumference
Time Frame
12 weeks of supplementation
Title
Grip Strength
Time Frame
Baseline (before supplementation)
Title
Grip Strength
Time Frame
8 weeks of supplementation
Title
Grip Strength
Time Frame
12 weeks of supplementation
Title
10-Meter Walk Test
Time Frame
Baseline (before supplementation)
Title
10-Meter Walk Test
Time Frame
8 weeks of supplementation
Title
10-Meter Walk Test
Time Frame
12 weeks of supplementation
Title
Testosterone level
Time Frame
Baseline (before supplementation)
Title
Testosterone level
Time Frame
8 weeks of supplementation
Title
Testosterone level
Time Frame
12 weeks of supplementation
Title
Cortisol level
Time Frame
Baseline (before supplementation)
Title
Cortisol level
Time Frame
8 weeks of supplementation
Title
Cortisol level
Time Frame
12 weeks of supplementation
Title
Growth Hormone level
Time Frame
Baseline (before supplementation)
Title
Growth Hormone level
Time Frame
8 weeks of supplementation
Title
Growth Hormone level
Time Frame
12 weeks of supplementation
Title
Insulin-like Growth Factor-1
Time Frame
Baseline (before supplementation)
Title
Insulin-like Growth Factor-1
Time Frame
8 weeks of supplementation
Title
Insulin-like Growth Factor-1
Time Frame
12 weeks of supplementation
Title
follistain level
Time Frame
Baseline (before supplementation)
Title
follistain level
Time Frame
8 weeks of supplementation
Title
follistain level
Time Frame
12 weeks of supplementation
Title
myostain level
Time Frame
Baseline (before supplementation)
Title
myostain level
Time Frame
8 weeks of supplementation
Title
myostain level
Time Frame
12 weeks of supplementation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: adult between 18-75 years old skeletal muscle mass in extremities by dual-energy X-ray absorptiometry less than 7.0 kg/m2 in men and less than 5.4 kg/m2 in women one of the following criteria were met: (1) handgrip strength less than 28 kg in men and less than 18 kg in women and (2) 5-time chair stand test over than 12 seconds Exclusion Criteria: The volunteers have history of cardiovascular, liver, kidney, and diabetes mellitus acute sport injury participated in any clinical trials or experimental research in the last 3 months before our experiment taking supplement during the experimental period did not maintain their regular eating habit or drink alcohol
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ming Ta Yang, Doctorate
Phone
886-2-27361661
Ext
2275
Email
yangrugby@tmu.edu.tw
Facility Information:
Facility Name
Taipei Medical University
City
Taipei
ZIP/Postal Code
110
Country
Taiwan

12. IPD Sharing Statement

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Pennisetum Purpureum in Sarcopenia Patients

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