Efficacy Assessment of Probiotics Product on Intestinal Health and Immune System Improvement

Efficacy Assessment of Probiotics Fruit Vegetable Fiber Powder on Intestinal Health and Immune System Improvement in Human Trial

The aim of this study is to investigate the effects of probiotics product (probiotics fruit vegetable fiber powder) on intestinal health and immune system improvement in adults

Study Overview

• Status: Recruiting
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Probiotics fruit vegetable fiber powder product; Dietary supplement: Placebo

Detailed Description

This 12 weeks randomized, single-blind and placebo-controlled study will be conduct in fifty adults. Subjects will be recruited and assigned into two groups in a 1:1 ratio (placebo, n = 25; probiotics, n=25). During the 12 weeks intervention, the subjects should take 32 g powder of placebo or probiotics product (eat 16 g for once, and twice a day). The two powder supplied in an aluminum sachet, and all products were identical in taste. Subjects also should complete the assessment of anthropometric measurement, health conditions, food record, and sample collection (feces and blood) at week 0, 4, 8 and week 12.

• Study Type: Interventional
• Enrollment (Anticipated): 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: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Inclusion criteria include male or female participants to be aged 20-60 years old, who had colds more than four times in the past year or had gastric Infection by Helicobacter pylori or peptic ulcer, body mass index within a healthy range (18.5-27 kg/m2) and willing to commit throughout the experiment.

Exclusion Criteria:

• Exclusion criteria included cancer, chronic heart disease, use drugs which pharmacological effects may affect immunity, have systemic infections, use probiotics, prebiotics, fruit vegetable fiber supplementation, and lactose Intolerance or cow's milk allergic. Individuals who, in opinion of the investigator, seemed unlikely to complete the trial were also excluded.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Probiotics; 32g probiotics fruit vegetable fiber powder product contained 1.12*10(11) CFU of probiotics for 12 weeks	Dietary supplement: Probiotics fruit vegetable fiber powder product; Eat 16 g for once, and twice a day; Other Names: Probiotics
Placebo Comparator: Placebo; 32g placebo contained only maltodextrin (100%) for 12 weeks	Dietary supplement: Placebo; Eat 16 g for once, and twice a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline serum TNF-α at week 12	Compared the difference of serum cytokine TNF-α level between the week 12 and 0	Week0, Week12
Change from baseline serum IL-6 at week 12	Compared the difference of serum IL-6 level between the week 12 and 0	Week0, Week12
Change from baseline serum IL-10 at week 12	Compared the difference of serum IL-10 level between the week 12 and 0	Week0, Week12

Collaborators and Investigators

• Sponsor: Chung Shan Medical University
• Collaborators: TCI Co., Ltd.
• Investigators: Principal Investigator: Yu-Jou Chien, PhD Student, Chung Shan Medical University; Principal Investigator: Ying-Chi Chen, MS Student, Chung Shan Medical University

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2021
• Primary Completion (Anticipated): September 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: May 23, 2021
• First Submitted That Met QC Criteria: May 23, 2021
• First Posted (Actual): May 26, 2021

Study Record Updates

• Last Update Posted (Actual): September 14, 2021
• Last Update Submitted That Met QC Criteria: September 12, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: CS2-21043

Drug and device information, study documents

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