UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037412
Receipt number R000042627
Scientific Title The effects of tart cherry supplementation on reducing late onset muscle soreness and improving sleep quality.
Date of disclosure of the study information 2019/07/29
Last modified on 2020/01/16 10:25:46

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Basic information

Public title

The effects of tart cherry supplementation on reducing late onset muscle soreness and improving sleep quality.

Acronym

The effects of tart cherries on muscle soreness and sleep quality.

Scientific Title

The effects of tart cherry supplementation on reducing late onset muscle soreness and improving sleep quality.

Scientific Title:Acronym

The effects of tart cherries on muscle soreness and sleep quality.

Region

Japan


Condition

Condition

healthy subjects

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to examine the effects of tart cherry supplementation on reducing late onset muscle soreness and improving sleep quality.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Visual analogue scale (VAS) of late-onset muscle soreness and the evaluation of questionnaire on sleep quality

Key secondary outcomes

salivary CRP as inflammatory index


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Placebo

Stratification

NO

Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Tart cherry suplementation

Interventions/Control_2

Placebo

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

60 years-old >

Gender

Male

Key inclusion criteria

Members of Folk dance club

Key exclusion criteria

People with allergy to cherry or with renal dysfunction

Target sample size

10


Research contact person

Name of lead principal investigator

1st name Masanori
Middle name
Last name Ohta

Organization

Fukuoka Women's University

Division name

International College of Arts and Sciences

Zip code

8813-8529

Address

1-1-1 Kasumigaoka, Higashi-ku, Fukuoka 813-8529, Japan

TEL

092-661-2411

Email

m-ohta@fwu.ac.jp


Public contact

Name of contact person

1st name Seiha
Middle name
Last name Harada

Organization

Fukuoka Women's University

Division name

Management Center

Zip code

8813-8529

Address

1-1-1 Kasumigaoka, Higashi-ku, Fukuoka 813-8529, Japan

TEL

092-661-2411

Homepage URL


Email

soumu5@fwu.ac.jp


Sponsor or person

Institute

Fukuoka Women's University

Institute

Department

Personal name



Funding Source

Organization

Fukuoka Women's University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Epidemiological Research Ethics Committee of Fukuoka Women's University

Address

1-1-1 Kasumigaoka, Higashi-ku, Fukuoka 813-8529, Japan

Tel

092-661-2411

Email

soumu5@fwu.ac.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 07 Month 29 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

7

Results

It was suggested that uptake of tart cherry supplementation for 1 week could improve sleep onset.

Results date posted

2020 Year 01 Month 16 Day

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

2019 Year 06 Month 26 Day

Date of IRB

2019 Year 06 Month 26 Day

Anticipated trial start date

2019 Year 07 Month 01 Day

Last follow-up date

2019 Year 10 Month 31 Day

Date of closure to data entry

2019 Year 10 Month 31 Day

Date trial data considered complete

2019 Year 10 Month 31 Day

Date analysis concluded

2020 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2019 Year 07 Month 18 Day

Last modified on

2020 Year 01 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042627


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name