Effect of Probiotics on Regulating Gut Health and Blood Lipid in Adults

Not Applicable

Recruiting

• Conditions: Obesity
• Interventions: Dietary Supplement: probiotics

• Registration Number: NCT06554314
• Lead Sponsor: Chung Shan Medical University

Brief Summary

The purpose of this study was to evaluate the efficacy of 1 capsules (300 mg per capsule) of Nutrarex Probiotic Capsules per day in regulating gut health and blood lipid in adults by clinical trial.

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. 50 subjects were randomized, 25 to placebo and 25 to probiotics. The subjects took one capsules of Nutrarex probiotics daily, a total of 300 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: 2024-05-17
• Status Verified: 2024-08
• Study First Submitted: 2024-08-12
• Study First Submitted QC: 2024-08-12
• Last Update Submitted: 2024-08-12
• Study First Posted: 2024-08-15
• Last Update Posted: 2024-08-15
• Primary Completion: 2024-12-31
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• male or female participants
• aged 20-65 years old
• body mass index in 25-27 kg/m2 or body fat > 25% for men and > 30% for women

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotics	probiotics	Probiotic capsules, 300 mg each, one daily for a total of 300 mg for 4 weeks
Placebo	probiotics	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.

Primary Outcome Measures

Name	Time	Method
Change from baseline serum lipids at week 4	Week0, Week4	Compared the difference of serum lipids level between the week 4 and 0

Trial Locations

Locations (1)

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