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

NCT ID: NCT06554314

Last Updated: 2024-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-17

Study Completion Date

2025-05-31

Brief Summary

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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

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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.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Probiotics

Probiotic capsules, 300 mg each, one daily for a total of 300 mg for 4 weeks

Group Type EXPERIMENTAL

probiotics

Intervention Type DIETARY_SUPPLEMENT

Eat a capsule for once, and once a day

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.

Group Type PLACEBO_COMPARATOR

probiotics

Intervention Type DIETARY_SUPPLEMENT

Eat a capsule for once, and once a day

Interventions

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probiotics

Eat a capsule for once, and once a day

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nutrarex Biotech Ltd.

UNKNOWN

Sponsor Role collaborator

Chung Shan Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yin-Chin Liu, MS student

Role: PRINCIPAL_INVESTIGATOR

Chung Shan Medical University

Locations

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Chung Shan Medical University

Taichung, South, Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Chin-Lin Hsu, Professor

Role: CONTACT

04-24730022 ext. 12222

Facility Contacts

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Chin-Lin Hsu, Professor

Role: primary

04-24730022 ext. 12222

Other Identifiers

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CS2-23191

Identifier Type: -

Identifier Source: org_study_id

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