Pennisetum Purpureum in Sarcopenia Patients

Not Applicable

Recruiting

• Conditions: Sarcopenia
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Pennisetum purpureum

• Registration Number: NCT05911516
• Lead Sponsor: Taipei Medical University

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.

Study Timeline

• Status Verified: 2023-05
• Study First Submitted: 2023-05-26
• Study Start: 2023-06-01
• Study First Submitted QC: 2023-06-19
• Study First Posted: 2023-06-22
• Last Update Submitted: 2023-12-18
• Last Update Posted: 2023-12-19
• Primary Completion: 2024-03
• Study Completion: 2024-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	Placebo	-
Pennisetum purpureum group	Pennisetum purpureum	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

Taipei Medical University; 🇨🇳 Taipei, Taiwan