UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044236
Receipt number R000050519
Scientific Title Effects of the combined use of hougu mixi and probiotics on intestinal flora, intestinal colonization of probiotics, and blood biochemical indicators in Chinese adults: a randomized crossover intervention trial
Date of disclosure of the study information 2021/05/17
Last modified on 2021/05/17 22:05:12

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Basic information

Public title

Effects of the combined use of hougu mixi and probiotics on intestinal flora, intestinal colonization of probiotics, and blood biochemical indicators in Chinese adults: a randomized crossover intervention trial

Acronym

hougu mixi and probiotics on health status

Scientific Title

Effects of the combined use of hougu mixi and probiotics on intestinal flora, intestinal colonization of probiotics, and blood biochemical indicators in Chinese adults: a randomized crossover intervention trial

Scientific Title:Acronym

hougu mixi and probiotics on health status

Region

Asia(except Japan)


Condition

Condition

healthy population

Classification by specialty

Medicine in general

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To determine whether hougumixi could improve health status among chinese adults.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The differences in serum lipid and gut microbiota changes.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Factorial

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -investigator(s) and assessor(s) are blinded

Control

Active

Stratification

YES

Dynamic allocation

NO

Institution consideration


Blocking


Concealment



Intervention

No. of arms

4

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

hougu mixi

Interventions/Control_2

hougu mixi plus probiotics

Interventions/Control_3

placebo plus probiotics

Interventions/Control_4

placebo

Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

18 years-old <=

Age-upper limit

60 years-old >=

Gender

Male and Female

Key inclusion criteria

(1)Male and female over 18 years old;

(2)Not taking other health care products in the last 6 months.

Key exclusion criteria

(1)participants who are taking health supplements in the last 6 months;
(2)with any physical diseases or mental diseases;
(3)taking antibiofic in the last 6 months;

(4)unable to complete intervention and examination over 6 months.

Target sample size

24


Research contact person

Name of lead principal investigator

1st name Kaijun
Middle name
Last name Niu

Organization

Tianjin Medical University

Division name

Nutrition and epidemiology institution

Zip code

300050

Address

22 Qixiangtai Road, Heping District, Tianjin, P.R.China.

TEL

+86(0)22-83336613

Email

nkj0809@gmail.com


Public contact

Name of contact person

1st name Huiping
Middle name
Last name Li

Organization

Tianjin Medical University

Division name

Nutrition and epidemiology institution

Zip code

300050

Address

22 Qixiangtai Road, Heping District, Tianjin, P.R.China.

TEL

+86(0)22-83336613

Homepage URL


Email

lihuiping1222@163.com


Sponsor or person

Institute

Tianjin Medical University,Nutrition and epidemiology institution

Institute

Department

Personal name



Funding Source

Organization

JIANGZHONG PHARMACEUTICAL CO.LTD

Organization

Division

Category of Funding Organization

Outside Japan

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Tianjin Medical University

Address

22 Qixiangtai Road, Heping District, Tianjin, P.R.China.

Tel

+86(0)22-83336613

Email

nkj0809@gmail.com


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2021 Year 05 Month 17 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled

24

Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

No longer recruiting

Date of protocol fixation

2020 Year 05 Month 30 Day

Date of IRB

2019 Year 12 Month 25 Day

Anticipated trial start date

2020 Year 06 Month 20 Day

Last follow-up date

2020 Year 12 Month 10 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 05 Month 17 Day

Last modified on

2021 Year 05 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050519


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name