Pennisetum Purpureum in Sarcopenia Patients

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

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

Study Overview

• Status: Recruiting
• Conditions: Sarcopenia
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Pennisetum purpureum

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ming Ta Yang, Doctorate; Phone Number: 2275 886-2-27361661; Email: yangrugby@tmu.edu.tw

Study Locations

• Taiwan
  • Taipei, Taiwan, 110
    • Recruiting
    • Taipei Medical University
    • Contact: Ming Ta Yang, Doctorate; Phone Number: 2275 886-2-27361661; Email: yangrugby@tmu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo group	Dietary supplement: Placebo; Placebo
Experimental: Pennisetum purpureum group	Dietary supplement: Pennisetum purpureum; 300mg Participants received 900mg of Pennisetum purpureum orally daily for 12 weeks

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Taipei Medical University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: May 26, 2023
• First Submitted That Met QC Criteria: June 19, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Estimated): December 19, 2023
• Last Update Submitted That Met QC Criteria: December 18, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Sarcopenia
• Other Study ID Numbers: N202305092

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No