Effects of Probiotic Capsules in Promoting Fat Excretion by Human Trial

Sponsor
Chung Shan Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05607524
Collaborator
Grape King Bio Ltd. (Industry)
60
1
2
3.6
16.8

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: probiotics
  • Dietary Supplement: placebo
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Prevention
Official Title:
Effects of Grape King Bio Probiotic Capsules in Promoting Fat Excretion by Human Trial
Actual Study Start Date :
Sep 29, 2022
Anticipated Primary Completion Date :
Dec 29, 2022
Anticipated Study Completion Date :
Jan 16, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Probiotics

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

Dietary Supplement: probiotics
Eat a capsule for once, and twice a day

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
Eat a capsule for once, and twice a day

Outcome Measures

Primary Outcome Measures

  1. Change from baseline fecel lipid weight at week 4 [Week0, Week4]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 40 Years
Sexes Eligible for Study:
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:
  • cancer, chronic heart disease, use drugs which pharmacological effects may affect immunity

  • having systemic infections

  • using probiotics.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chung Shan Medical University Taichung South Taiwan 402

Sponsors and Collaborators

  • Chung Shan Medical University
  • Grape King Bio Ltd.

Investigators

  • Principal Investigator: Yu-Jou Chien, PhD student, Chung Shan Medical University
  • Principal Investigator: Xin-Bei Lin, MS student, Chung Shan Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Chin-Lin Hsu, Professor, Chung Shan Medical University
ClinicalTrials.gov Identifier:
NCT05607524
Other Study ID Numbers:
  • CS2-22068
First Posted:
Nov 7, 2022
Last Update Posted:
Nov 7, 2022
Last Verified:
Nov 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Nov 7, 2022