NCT04903600

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 22, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 23, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 26, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

September 14, 2021

Status Verified

September 1, 2021

Enrollment Period

4 months

First QC Date

May 23, 2021

Last Update Submit

September 12, 2021

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

Probiotics

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

32g placebo contained only maltodextrin (100%) for 12 weeks

Dietary Supplement: Placebo

Interventions

Probiotics fruit vegetable fiber powder productDIETARY_SUPPLEMENT

Eat 16 g for once, and twice a day

Also known as: Probiotics
Probiotics
PlaceboDIETARY_SUPPLEMENT

Eat 16 g for once, and twice a day

Placebo

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chung Shan Medical University

Taichung, South, 402, Taiwan

RECRUITING

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Yu-Jou Chien, PhD Student

    Chung Shan Medical University

    PRINCIPAL INVESTIGATOR

  • Ying-Chi Chen, MS Student

    Chung Shan Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chin-Lin Hsu, Professor

CONTACT

04-24730022clhsu@csmu.edu.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 23, 2021

First Posted

May 26, 2021

Study Start

April 22, 2021

Primary Completion

September 1, 2021

Study Completion

December 1, 2021

Last Updated

September 14, 2021

Record last verified: 2021-09

Locations

TW(1)