Effects of Probiotic Capsules in Promoting Fat Excretion by Human Trial

Not Applicable

Recruiting

• Conditions: Obesity
• Interventions: Dietary Supplement: placebo; Dietary Supplement: probiotics

• Registration Number: NCT05607524
• Lead Sponsor: Chung Shan Medical University

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.

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 Timeline

• Study Start: 2022-09-29
• Study First Submitted: 2022-10-28
• Status Verified: 2022-11
• Study First Submitted QC: 2022-11-01
• Last Update Submitted: 2022-11-01
• Study First Posted: 2022-11-07
• Last Update Posted: 2022-11-07
• Primary Completion: 2022-12-29
• Study Completion: 2023-01-16

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	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.
Probiotics	probiotics	Probiotic capsules, 500 mg each, two daily for a total of 1000 mg for 4 weeks

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Chung Shan Medical University; 🇨🇳 Taichung, South, Taiwan