Effects of Probiotic Capsules in Promoting Fat Excretion by Human Trial

NCT ID: NCT05607524

Last Updated: 2022-11-07

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-29

Study Completion Date

2023-01-16

Brief Summary

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The purpose of this study was to evaluate the efficacy of 2 capsules (500 mg per capsule, 1000 mg per day) of Grape King Probiotic Capsules per day in promoting fat excretion in obese patients by clinical human food test.

Detailed Description

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This experiment is carried out in a controlled manner. Before the subjects enter the research experiment, they need to follow their original lifestyle. The habits of maintaining a constant body weight for more than 2 weeks before the test, such as calorie balance in the diet and the amount of activity. Then enter the test to carry out the evaluation test of probiotics to the end. 60 subjects were randomized, 20 to placebo and 40 to probiotics. The subjects took two capsules of Grape King probiotics daily, a total of 1000 mg. Continue to take it for 4 weeks, and perform blood routine tests. Body composition detection, waist and hip circumference measurement, related index analysis and 24-hour dietary questionnaires, gut health questionnaires and stool samples were collected and analyzed for 4 weeks before and after treatment.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Probiotics

Probiotic capsules, 500 mg each, two daily for a total of 1000 mg for 4 weeks

Group Type EXPERIMENTAL

probiotics

Intervention Type DIETARY_SUPPLEMENT

Eat a capsule for once, and twice a day

Placebo

The placebo capsules had the same composition as the experimental capsules, except that they did not contain probiotics, and should be used for 4 weeks.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DIETARY_SUPPLEMENT

Eat a capsule for once, and twice a day

Interventions

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probiotics

Eat a capsule for once, and twice a day

Intervention Type DIETARY_SUPPLEMENT

placebo

Eat a capsule for once, and twice a day

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* male or female participants
* aged 20-40 years old
* body mass index in 25-27 kg/m2
* body fat \> 25% for men and \> 30% for women

Exclusion Criteria

* cancer, chronic heart disease, use drugs which pharmacological effects may affect immunity
* having systemic infections
* using probiotics.
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Grape King Bio Ltd.

INDUSTRY

Sponsor Role collaborator

Chung Shan Medical University

OTHER

Sponsor Role lead

Responsible Party

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Chin-Lin Hsu

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yu-Jou Chien, PhD student

Role: PRINCIPAL_INVESTIGATOR

Chung Shan Medical University

Xin-Bei Lin, MS student

Role: PRINCIPAL_INVESTIGATOR

Chung Shan Medical University

Locations

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Chung Shan Medical University

Taichung, South, Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Chin-Lin Hsu, Professor

Role: CONTACT

04-24730022 ext. 12222

Facility Contacts

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Chin-Lin Hsu, Professor

Role: primary

04-24730022 ext. 12222

Other Identifiers

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CS2-22068

Identifier Type: -

Identifier Source: org_study_id

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