Clinical trial NCT05911516: Pennisetum Purpureum in Sarcopenia Patients
Official title: Effects of Pennisetum Purpureum Health Food Supplementation on Muscle Mass and Muscle Strength
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sarcopenia
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2023-06-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Body height
timeFrame: Baseline (before supplementation)
measure: Body height
timeFrame: 8 weeks of supplementation
measure: Body height
timeFrame: 12 weeks of supplementation
measure: Body weight
timeFrame: Baseline (before supplementation)
measure: Body weight
timeFrame: 8 weeks of supplementation
measure: Body weight
timeFrame: 12 weeks of supplementation
measure: BMI (body mass index)
timeFrame: Baseline (before supplementation)
measure: BMI (body mass index)
timeFrame: 8 weeks of supplementation
measure: BMI (body mass index)
timeFrame: 12 weeks of supplementation
measure: Systolic blood pressure
timeFrame: Baseline (before supplementation)
measure: Systolic blood pressure
timeFrame: 8 weeks of supplementation
measure: Systolic blood pressure
timeFrame: 12 weeks of supplementation
measure: Diastolic blood pressure
timeFrame: Baseline (before supplementation)
measure: Diastolic blood pressure
timeFrame: 8 weeks of supplementation
measure: Diastolic blood pressure
timeFrame: 12 weeks of supplementation
measure: ASM (Appendicular Skeletal Muscle Mass)
timeFrame: 12 weeks of supplementation
measure: ASM (Appendicular Skeletal Muscle Mass)
timeFrame: 8 weeks of supplementation
measure: Upper Arm Circumference
timeFrame: Baseline (before supplementation)
measure: Upper Arm Circumference
timeFrame: 8 weeks of supplementation
measure: Upper Arm Circumference
timeFrame: 12 weeks of supplementation
measure: Thigh Circumference
timeFrame: Baseline (before supplementation)
measure: Thigh Circumference
timeFrame: 8 weeks of supplementation
measure: Thigh Circumference
timeFrame: 12 weeks of supplementation
measure: Grip Strength
timeFrame: Baseline (before supplementation)
measure: Grip Strength
timeFrame: 8 weeks of supplementation
measure: Grip Strength
timeFrame: 12 weeks of supplementation
measure: 10-Meter Walk Test
timeFrame: Baseline (before supplementation)
measure: 10-Meter Walk Test
timeFrame: 8 weeks of supplementation
measure: 10-Meter Walk Test
timeFrame: 12 weeks of supplementation
measure: Testosterone level
timeFrame: Baseline (before supplementation)
measure: Testosterone level
timeFrame: 8 weeks of supplementation
measure: Testosterone level
timeFrame: 12 weeks of supplementation
measure: Cortisol level
timeFrame: Baseline (before supplementation)
measure: Cortisol level
timeFrame: 8 weeks of supplementation
measure: Cortisol level
timeFrame: 12 weeks of supplementation
measure: Growth Hormone level
timeFrame: Baseline (before supplementation)
measure: Growth Hormone level
timeFrame: 8 weeks of supplementation
measure: Growth Hormone level
timeFrame: 12 weeks of supplementation
measure: Insulin-like Growth Factor-1
timeFrame: Baseline (before supplementation)
measure: Insulin-like Growth Factor-1
timeFrame: 8 weeks of supplementation
measure: Insulin-like Growth Factor-1
timeFrame: 12 weeks of supplementation
measure: follistain level
timeFrame: Baseline (before supplementation)
measure: follistain level
timeFrame: 8 weeks of supplementation
measure: follistain level
timeFrame: 12 weeks of supplementation
measure: myostain level
timeFrame: Baseline (before supplementation)
measure: myostain level
timeFrame: 8 weeks of supplementation
measure: myostain level
timeFrame: 12 weeks of supplementation
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University
Study officials:
References: