UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034277
Receipt number R000038981
Scientific Title The effect of the algal food intake on elderly volunteers a randomized, double-blind, placebo-controlled, parallel-group study
Date of disclosure of the study information 2019/09/19
Last modified on 2020/06/12 11:21:43

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Basic information

Public title

The effect of the algal food intake on elderly volunteers
a randomized, double-blind, placebo-controlled, parallel-group study

Acronym

The effect of the algal food intake on elderly volunteers

Scientific Title

The effect of the algal food intake on elderly volunteers
a randomized, double-blind, placebo-controlled, parallel-group study

Scientific Title:Acronym

The effect of the algal food intake on elderly volunteers

Region

Japan


Condition

Condition

Healthy elderly people

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effect of the algal food intake on testosterone

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

testosterone

Key secondary outcomes

QOL
Immune function


Base

Study type

Interventional


Study design

Basic design

Parallel

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

65 years-old <=

Age-upper limit

75 years-old >=

Gender

Male and Female

Key inclusion criteria

(1)Healty people who are 65 or more to less than 75 years old.
(2)individual who can be ambulatory.
(3)Individuals who can answer the quetionair.
(4)Individuals who don't increase or decrease the amount of meals.
(5)Individuals who don't have irregular or disturbed life style such as night shifts.

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)Individuals who is diagnosed as menopausal disorder and not treated.
(4)Individuals who are prone to allergies for foods.
(5)Individuals who have participated in other clinical studies within the past 3 months.
(6)Individuals who intake algal food.
(7)Individuals judged inappropriate for the study by the principal.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Madoka
Middle name
Last name Takahashi

Organization

KOBELCO ECO-SOULUTIONS CO.,LTD

Division name

Technical Develop Center

Zip code

651-2241

Address

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

TEL

078-992-6957

Email

md.takahashi@kobelco-eco.co.jp


Public contact

Name of contact person

1st name Madoka
Middle name
Last name Takahashi

Organization

KOBELCO ECO-SOULUTIONS CO.,LTD

Division name

Technical Develop Center

Zip code

651-2241

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

Medical Corporation Hokubukai Utsukushigaoka hospital

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

Medical Corporation Hokubukai Utsukushigaoka hospital

Address

61-1, Shinei, Kiyota-ku, Sapporo 651-2241, Japan

Tel

011-882-0111

Email

wakimoto@ughp-cpc.jp


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

2019 Year 09 Month 19 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 09 Month 12 Day

Date of IRB

2018 Year 09 Month 13 Day

Anticipated trial start date

2018 Year 10 Month 04 Day

Last follow-up date

2018 Year 12 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 09 Month 26 Day

Last modified on

2020 Year 06 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038981


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name