Pennisetum Purpureum in Sarcopenia Patients

Sarcopenia Clinical Trial

Official title:

Effects of Pennisetum Purpureum Health Food Supplementation on Muscle Mass and Muscle Strength

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05911516
• Other study ID #: N202305092
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: March 2024

Study information

• Verified date: May 2023
• Source: Taipei Medical University
• Contact: Ming Ta Yang, Doctorate
• Phone: 886-2-27361661
• Email: yangrugby[@]tmu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to investigate the effects of Pennisetum purpureum health food supplementation on muscle mass and muscle strength.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. adult between 18-75 years old

2. 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

3. 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:

1. The volunteers have history of cardiovascular, liver, kidney, and diabetes mellitus

2. acute sport injury

3. participated in any clinical trials or experimental research in the last 3 months before our experiment

4. taking supplement during the experimental period

5. did not maintain their regular eating habit or drink alcohol

Related Conditions & MeSH terms

• Sarcopenia

Intervention

Dietary Supplement:
• Pennisetum purpureum
300mg Participants received 900mg of Pennisetum purpureum orally daily for 12 weeks
• Placebo
Placebo

Locations

Country	Name	City	State
Taiwan	Taipei Medical University	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body height		Baseline (before supplementation)
Primary	Body height		8 weeks of supplementation
Primary	Body height		12 weeks of supplementation
Primary	Body weight		Baseline (before supplementation)
Primary	Body weight		8 weeks of supplementation
Primary	Body weight		12 weeks of supplementation
Primary	BMI (body mass index)		Baseline (before supplementation)
Primary	BMI (body mass index)		8 weeks of supplementation
Primary	BMI (body mass index)		12 weeks of supplementation
Primary	Systolic blood pressure		Baseline (before supplementation)
Primary	Systolic blood pressure		8 weeks of supplementation
Primary	Systolic blood pressure		12 weeks of supplementation
Primary	Diastolic blood pressure		Baseline (before supplementation)
Primary	Diastolic blood pressure		8 weeks of supplementation
Primary	Diastolic blood pressure		12 weeks of supplementation
Primary	ASM (Appendicular Skeletal Muscle Mass)		12 weeks of supplementation
Primary	ASM (Appendicular Skeletal Muscle Mass)		8 weeks of supplementation
Primary	Upper Arm Circumference		Baseline (before supplementation)
Primary	Upper Arm Circumference		8 weeks of supplementation
Primary	Upper Arm Circumference		12 weeks of supplementation
Primary	Thigh Circumference		Baseline (before supplementation)
Primary	Thigh Circumference		8 weeks of supplementation
Primary	Thigh Circumference		12 weeks of supplementation
Primary	Grip Strength		Baseline (before supplementation)
Primary	Grip Strength		8 weeks of supplementation
Primary	Grip Strength		12 weeks of supplementation
Primary	10-Meter Walk Test		Baseline (before supplementation)
Primary	10-Meter Walk Test		8 weeks of supplementation
Primary	10-Meter Walk Test		12 weeks of supplementation
Primary	Testosterone level		Baseline (before supplementation)
Primary	Testosterone level		8 weeks of supplementation
Primary	Testosterone level		12 weeks of supplementation
Primary	Cortisol level		Baseline (before supplementation)
Primary	Cortisol level		8 weeks of supplementation
Primary	Cortisol level		12 weeks of supplementation
Primary	Growth Hormone level		Baseline (before supplementation)
Primary	Growth Hormone level		8 weeks of supplementation
Primary	Growth Hormone level		12 weeks of supplementation
Primary	Insulin-like Growth Factor-1		Baseline (before supplementation)
Primary	Insulin-like Growth Factor-1		8 weeks of supplementation
Primary	Insulin-like Growth Factor-1		12 weeks of supplementation
Primary	follistain level		Baseline (before supplementation)
Primary	follistain level		8 weeks of supplementation
Primary	follistain level		12 weeks of supplementation
Primary	myostain level		Baseline (before supplementation)
Primary	myostain level		8 weeks of supplementation
Primary	myostain level		12 weeks of supplementation