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

Chung Shan Medical University50 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Healthy

Interventions

Probiotics fruit vegetable fiber powder productDIETARY_SUPPLEMENT

Eat 16 g for once, and twice a day

PlaceboDIETARY_SUPPLEMENT

Eat 16 g for once, and twice a day

Eligibility

Sex: ALLMin age: 20 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Chung Shan Medical University

Taichung, South, Taiwan

RECRUITING

Outcomes

Primary Outcomes

Change from baseline serum TNF-α at week 12

Compared the difference of serum cytokine TNF-α level between the week 12 and 0

Time frame: 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

Time frame: 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

Time frame: Week0, Week12

Central Contacts

Chin-Lin Hsu, Professor

CONTACT

04-24730022 clhsu@csmu.edu.tw

Data from ClinicalTrials.gov

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