UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035545
Receipt number R000040498
Scientific Title The effect of the algal food intake on bowel movement and on intestinal environment a randomized, double-blind, placebo-controlled, cross-over study
Date of disclosure of the study information 2020/01/10
Last modified on 2020/04/03 13:36:37

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Basic information

Public title

The effect of the algal food intake on bowel movement and on intestinal environment
a randomized, double-blind, placebo-controlled, cross-over study

Acronym

The effect of the algal food intake on bowel movement and on intestinal environment

Scientific Title

The effect of the algal food intake on bowel movement and on intestinal environment
a randomized, double-blind, placebo-controlled, cross-over study

Scientific Title:Acronym

The effect of the algal food intake on bowel movement and on intestinal environment

Region

Japan


Condition

Condition

Healthy young woman

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effect of the algal food intake on bowel movement and on intestinal environment

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Defecation frequency

Key secondary outcomes

Fecal amount, Fecal properties.
Intestinal flora, Subjective evaluation (Sleep, Feeling of exhaustion, Feeling)


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

algal food

Interventions/Control_2

placebo control food

Interventions/Control_3


Interventions/Control_4


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

29 years-old >=

Gender

Female

Key inclusion criteria

(1)Healty woman who are 18 or more to less than 29 years old
(2)Healthy Japanese subjects who defecate three to five times per week
(3)Healty Japanese subjects who do not have major changes in the living environment during the experiment

Key exclusion criteria

(1)Individuals who has treatment or history of malignant tumor, heart failure, myocardial infarction, psychiatric disorder.
(2)Individuals who is being treated for arrhythmia, liver disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes, erectile dysfunction, thyroid disorder.
(3)Subjects who use or take "Foods for Specified Health Uses", "Foods with Function Claims", or other functional food/beverage in daily
(4)Individuals who intake algal food.
(5)Subjects who are currently taking medications (including herbal medicines) and dietary supplements
(6)Subjects who are allergic to medicines and/or the test food related
(7)Subjects who are pregnant, breast-feeding, or planning to become pregnant
(8)Individuals who have participated in other clinical studies within the past 1 month.
(9)Individuals judged inappropriate for the study by the principal

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiramatsu Satoko

Organization

Okayama Prefectural University

Division name

Faculty of Health and Welfare Science

Zip code


Address

111 Kuboki, Soja-shi, Okayama, 719-1197, Japan

TEL

0866-94-2111

Email

shiramatsu@fhw.oka-pu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takahashi Madoka

Organization

KOBELCO ECO-SOULUTIONS CO.,LTD.

Division name

Technical Develop Center

Zip code


Address

1-1-4, Murotani, Nishi-ku, Kobe 651-2241, Japan

TEL

078-992-6957

Homepage URL


Email

md.takahashi@kobelco-eco.co.jp


Sponsor or person

Institute

Okayama Prefectural University

Institute

Department

Personal name



Funding Source

Organization

KOBELCO ECO-SOULUTIONS CO.,LTD.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2020 Year 01 Month 10 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


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

Completed

Date of protocol fixation

2018 Year 11 Month 22 Day

Date of IRB

2018 Year 11 Month 22 Day

Anticipated trial start date

2019 Year 01 Month 23 Day

Last follow-up date

2019 Year 04 Month 18 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 01 Month 15 Day

Last modified on

2020 Year 04 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040498


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name