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Status unknownNCT05607524Updated Nov 7, 2022

Effects of Probiotic Capsules in Promoting Fat Excretion by Human Trial

An interventional study of probiotics and placebo in Obesity, sponsored by Chung Shan Medical University. Status unknown at 1 site in Taiwan. Open to participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-07.

Sponsored by Chung Shan Medical University · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Nov 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
20 Years to 40 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Obesity
03

In context

Lead sponsor

Chung Shan Medical University is the lead sponsor of 124 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • cancer, chronic heart disease, use drugs which pharmacological effects may affect immunity
  • having systemic infections
  • using probiotics.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Probiotics

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

    Dietary Supplement: probiotics

  • Placebo comparator
    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.

    Dietary Supplement: placebo

Interventions

  • Dietary supplementprobiotics

    Eat a capsule for once, and twice a day

  • Dietary supplementplacebo

    Eat a capsule for once, and twice a day

06

What researchers measure

Primary outcomes

  1. Change from baseline fecel lipid weight at week 4

    Compared the difference of fecel lipid weight level between the week 4 and 0

    Time frame: Week0, Week4

07

Study locations

1 of 1 sites recruiting
  • Chung Shan Medical University
    Taichung, South 402, Taiwan
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 7, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05607524
Lead sponsor
Chung Shan Medical University
Collaborators
Grape King Bio Ltd.
Responsible party
Chin-Lin Hsu (Professor, Chung Shan Medical University) — Principal investigator
First posted
Nov 7, 2022
Start date
Sep 29, 2022
Primary completion
Dec 29, 2022 (estimated)
Completion
Jan 16, 2023 (estimated)
Last update
Nov 7, 2022

Study contacts

Chin-Lin Hsu, Professor
Contact
clhsu@csmu.edu.tw
04-24730022 ext. 12222
Yu-Jou Chien, PhD student
principal investigator · Chung Shan Medical University
Xin-Bei Lin, MS student
principal investigator · Chung Shan Medical University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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