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Pennisetum Purpureum in Sarcopenia Patients

NCT ID: NCT05911516

Last Updated: 2023-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2024-03-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Sarcopenia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
A double-blind, matched-pair study design

Study Groups

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Pennisetum purpureum group

Group Type EXPERIMENTAL

Pennisetum purpureum

Intervention Type DIETARY_SUPPLEMENT

300mg Participants received 900mg of Pennisetum purpureum orally daily for 12 weeks

Placebo group

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo

Interventions

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Pennisetum purpureum

300mg Participants received 900mg of Pennisetum purpureum orally daily for 12 weeks

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taipei Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Taipei Medical University

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Ming Ta Yang, Doctorate

Role: CONTACT

Phone: 886-2-27361661

Email: [email protected]

Facility Contacts

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Ming Ta Yang, Doctorate

Role: primary

Other Identifiers

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N202305092

Identifier Type: -

Identifier Source: org_study_id