Pennisetum Purpureum in Sarcopenia Patients | NCT05911516

Studies
Pennisetum Purpureum in Sarcopenia Patients

NCT05911516

Sponsor

Taipei Medical University

Status

Unknown status

Last Update Posted

Dec 19, 2023Actual

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Sarcopenia

Interventions

Pennisetum purpureum
Placebo

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2023Actual

Primary Completion Date

Mar 2024Estimated

Completion Date

Mar 2024Estimated

First Submitted Date

May 26, 2023

First Submission Date that Met QC Criteria

Jun 19, 2023

First Posted Date

Jun 22, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 18, 2023

Last Update Posted Date

Dec 19, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pennisetum purpureum group	Experimental		Dietary Supplement: Pennisetum purpureum
Placebo group	Placebo Comparator		Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pennisetum purpureum	Dietary Supplement	300mg Participants received 900mg of Pennisetum purpureum orally daily for 12 weeks	Pennisetum purpureum group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ming Ta Yang, Doctorate	Contact	886-2-27361661	2275	yangrugby@tmu.edu.tw

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Taipei Medical University	Recruiting	Taipei		110	Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D055948	Sarcopenia

Ancestor Terms

ID	Term
D009133	Muscular Atrophy
D020879	Neuromuscular Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

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.