UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031005
Receipt number R000035398
Scientific Title Effect of Daily Intake of Nutritional Jelly on Fatigue: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study
Date of disclosure of the study information 2018/01/26
Last modified on 2018/09/25 16:13:58

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Basic information

Public title

Effect of Daily Intake of Nutritional Jelly on Fatigue: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study

Acronym

Beneficial Effects of Nutritional Jelly on Fatigue

Scientific Title

Effect of Daily Intake of Nutritional Jelly on Fatigue: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study

Scientific Title:Acronym

Beneficial Effects of Nutritional Jelly on Fatigue

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To prove clinical benefits associated with 8 week daily intake of nutritional jelly on fatigue and other feeling accompanying nutrition improvement.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Chalder fatigue scale at 4 and 8 weeks after beginning the intake of test food.

Key secondary outcomes

VAS questionnaire assessed fatigue, salivary chromogranin A before and after fatigue loading, POMS-2, LF/HF ratio, Alb, TP, A/G ratio, ChE, Hb, MCV, ferritin, UIBC, TIBC, Fe, Zinc, selenium, copper,V.A, V.B1,V.B2,V.B6, V.B12, 1-alpha,25-(OH)2-V.D, V.E, V.C, folic acid, serum cortisol, d-ROM, BAP, food frequency questionnaire, questionnaire assessed feeling after ingesting test food, diary-test food intake situation (taste, ingestion situation, hunger, tiredness, feeling etc.)


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

NO

Institution consideration


Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Daily intake of 150 g of active test food for 8 weeks.

Interventions/Control_2

Daily intake of 150 g of placebo food for 8 weeks.

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

20 years-old <=

Age-upper limit

70 years-old >

Gender

Male and Female

Key inclusion criteria

1.Subjects with feeling fatigue daily.
2.Subjects with unbalanced dietary habit.
3.Subjects who agree to participate in this study with a written informed consent.

Key exclusion criteria

1.Subjects who are under physician's advice, treatment, and/or medication for schizophrenia, depression, mania, neurological disorders, and/or sleep disorders.
2.Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, and/or affected with infectious diseases requiring reports to the authorities.
3.Subjects with major surgical history relevant to the digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc.
4.Subjects with unusually high and/or low blood pressure and/or abnormal hematological data.
5.Subjects with severe anemia.
6.Pre- or post-menopausal women complaining of obvious physical changes.
7.Subjects who are at risk of having allergic reactions to drugs.
8.Subjects who take medicine, functional foods, nutritional food, and/or nutritional drink which contain V.A and/or V.D.
9.Subjects who take medicine, functional foods, nutritional food, and/or nutritional drink which contain vitamin other than V.A /V.D and/or mineral (iron, zinc, copper, and selenium).
10.Heavy smokers, alcohol addicts or subjects with eating disordered lifestyle.
11.Subjects who donated either 400 ml whole blood within 16 weeks (women), 12 weeks (men), 200 ml whole blood within 4 weeks (men and women), or blood components within 2 weeks (men and women), prior to the current study.
12.Pregnant or lactating women or women who expect to be pregnant during this study.
13.Subjects who currently participate in other clinical trials, or participated within the last 4 weeks prior to the current study.
14.Any other medical and/or health reasons unfavorable to participation in the current study, as judged by the principal investigator.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Prof. Jun NISHIHIRA, M.D., Ph.D.

Organization

Hokkaido Information University

Division name

Department of Medical Management and Informatics

Zip code


Address

59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan

TEL

011-385-4411

Email

nishihira@do-johodai.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Dir. Prof. Jun NISHIHIRA, M.D., Ph.D.

Organization

Hokkaido Information University

Division name

Health Information Science Research Center

Zip code


Address

59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan

TEL

011-385-4430

Homepage URL


Email

nishihira@do-johodai.ac.jp


Sponsor or person

Institute

Hokkaido Information University

Institute

Department

Personal name



Funding Source

Organization

Meiji Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


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

北海道情報大学 保健センター(北海道)


Other administrative information

Date of disclosure of the study information

2018 Year 01 Month 26 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

2017 Year 12 Month 22 Day

Date of IRB


Anticipated trial start date

2018 Year 01 Month 31 Day

Last follow-up date

2018 Year 05 Month 18 Day

Date of closure to data entry

2018 Year 05 Month 22 Day

Date trial data considered complete

2018 Year 05 Month 23 Day

Date analysis concluded

2018 Year 08 Month 31 Day


Other

Other related information



Management information

Registered date

2018 Year 01 Month 25 Day

Last modified on

2018 Year 09 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035398


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name