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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity
• Intervention / Treatment: Dietary supplement: probiotics

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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chin-Lin Hsu, Professor; Phone Number: 12222 04-24730022; Email: clhsu@csmu.edu.tw

Study Locations

• Taiwan
  • South
    • Taichung, South, Taiwan, 402
      • Recruiting
      • Chung Shan Medical University
      • Contact: Chin-Lin Hsu, Professor; Phone Number: 12222 04-24730022; Email: clhsu@csmu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: probiotics; Eat a capsule for once, and once a day
Experimental: Probiotics; Probiotic capsules, 300 mg each, one daily for a total of 300 mg for 4 weeks	Dietary supplement: probiotics; Eat a capsule for once, and once a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline serum lipids at week 4	Compared the difference of serum lipids level between the week 4 and 0	Week0, Week4

Collaborators and Investigators

• Sponsor: Chung Shan Medical University
• Collaborators: Nutrarex Biotech Ltd.
• Investigators: Principal Investigator: Yin-Chin Liu, MS student, Chung Shan Medical University

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): May 31, 2025

Study Registration Dates

• First Submitted: August 12, 2024
• First Submitted That Met QC Criteria: August 12, 2024
• First Posted (Actual): August 15, 2024

Study Record Updates

• Last Update Posted (Actual): August 15, 2024
• Last Update Submitted That Met QC Criteria: August 12, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: CS2-23191

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No