UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036638
Receipt number R000041733
Scientific Title Study on the actions of MAF (high molecular-weight polyphenol) on the effects of light exercise conducted by middle-aged and elderly women
Date of disclosure of the study information 2019/05/06
Last modified on 2023/05/13 16:09:49

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Basic information

Public title

Study on the actions of MAF (high molecular-weight polyphenol) on the effects of light exercise conducted by middle-aged and elderly women

Acronym

Study on the actions of MAF on the effects of light exercise

Scientific Title

Study on the actions of MAF (high molecular-weight polyphenol) on the effects of light exercise conducted by middle-aged and elderly women

Scientific Title:Acronym

Study on the actions of MAF on the effects of light exercise

Region

Japan


Condition

Condition

lifestyle-related diseases

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the efficacy of MAF on the effects of light exercise conducted by middle-aged and elderly women

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

physical fitness age, before and after 80 days intervention study

Key secondary outcomes

muscle mass, strength and fat mass, before and after 80 days intervention study


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

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

placebo

Interventions/Control_2

intervention period: 80 days

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

55 years-old <=

Age-upper limit

69 years-old >=

Gender

Female

Key inclusion criteria

Curves member who participates regular program for more than 2 times/week

Key exclusion criteria

have serious disease

Target sample size

70


Research contact person

Name of lead principal investigator

1st name Tohru
Middle name
Last name Takemasa

Organization

University of Tsukuba

Division name

Faculty of Health and Sport Sciences

Zip code

305-8574

Address

Ten-noudai 1-1-1, Tsukuba, Ibaraki

TEL

029-853-2622

Email

takemasa.tohru.gm@u.tsukuba.ac.jp


Public contact

Name of contact person

1st name Tohru
Middle name
Last name Takemasa

Organization

University of Tsukuba

Division name

Faculty of Health and Sport Sciences

Zip code

305-8574

Address

Ten-noudai 1-1-1, Tsukuba, Ibaraki

TEL

029-853-2622

Homepage URL


Email

takemasa.tohru.gm@u.tsukuba.ac.jp


Sponsor or person

Institute

University of Tsukuba

Institute

Department

Personal name



Funding Source

Organization

Curves Japan

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

University of Tsukuba

Address

Ten-noudai 1-1-1, Tsukuba, Ibaraki

Tel

029-859-2571

Email

hitorinri@un.tsukuba.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 05 Month 06 Day


Related information

URL releasing protocol

https://www.jstage.jst.go.jp/article/jspfsm/70/3/70_199/_article/-char/ja

Publication of results

Published


Result

URL related to results and publications

https://www.jstage.jst.go.jp/article/jspfsm/70/3/70_199/_article/-char/ja

Number of participants that the trial has enrolled

70

Results

This study examined the effect of high molecular weight polyphenol MAF supplementation in black tea and oolong tea on the overall physical fitness (expressed as physical age) of physically active middle-aged and older women. Seventy middle-aged women aged 55-69 were randomly assigned to placebo (n = 35) and MAF groups (n = 35). Physical age decreased by 1.48 years in the placebo group and 3.01 years in the MAF group.

Results date posted

2021 Year 08 Month 01 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2021 Year 02 Month 06 Day

Baseline Characteristics

Research participants are in Tsukuba City and Tsuchiura City, Ibaraki Prefecture
The posters for the research participants of this research were posted at the three stores of the health gymnastics class (hereinafter referred to as "Curves") established by Curves Japan Co., Ltd. Circuit exercise to participate more than once
Habitual persons, (2) Middle-aged women aged 55 to 69 years. Exercise history at Curves is not a particular selection criterion. Exclusion criteria are those with serious illness. If more than 70 applicants do not meet the exclusion criteria, the weight, BMI, and age will be taken into consideration, and at the discretion of the principal investigator (Takemasa), more than 70 applicants will be excluded from the study. rice field.

Participant flow

Looking at the bulletin board, 85 people indicated their intention to participate in the research, but 5 people declined to participate in the research before the preliminary explanation session. 80 people participated in the preliminary briefing session and physical fitness test, but the briefing session One later declined to participate. At the discretion of the principal investigator (Takemasa), the remaining 79 were excluded from the three heaviest and the lightest. The remaining 73 had the highest BMI. We excluded the two highest and one lowest, and determined 70 study participants. 70 study participants were divided into placebo (n = 35) and MAF (n = 35) groups and interventions. Three study participants declined to measure their physical fitness after the supplement intake period, because the supplement intake prepared for abdominal tension, herpes zoster, and endoscopy. Participants with abdominal tension and those with herpes zoster are placebo
He was a research participant belonging to the group.
The 80-day supplement intake was 96.9% and 93.2% on average in the placebo and MAF groups, respectively, and the intake rate was significantly higher in the placebo group (p = 0.01). In addition, the participation in the circuit exercise program was in the placebo group. , MAF groups averaged 3.11 times / week and 2.97 times / week (p = 0.55). No serious adverse events were reported from supplement intake for 80 days. The protein intake in each group was placebo. There were 16 in the group and 17 in the MAF group (p = 0.89).

Adverse events

NA

Outcome measures

In this study, the age of physical fitness proposed by Tanaka et al. was used as the main analysis item. This is an age scale that evaluates the physical fitness of the elderly. This study targets middle-aged and elderly women, and adopts the age of vitality with the intention of being able to easily measure and evaluate the physical fitness in daily life. The secondary analysis items were grip force measured for calculating the age of physical fitness, standing on one leg with eyes closed, forward bending of the long sitting body, standing time, continuous upper arm flexion and extension, figure eight walking, functional reach, continuous standing up motion, and DXA. Bone mineral content, bone density, fat mass, fat loss mass, and body fat percentage quantified by

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2018 Year 11 Month 14 Day

Date of IRB

2018 Year 11 Month 20 Day

Anticipated trial start date

2019 Year 05 Month 06 Day

Last follow-up date

2019 Year 07 Month 31 Day

Date of closure to data entry

2019 Year 08 Month 31 Day

Date trial data considered complete

2019 Year 09 Month 16 Day

Date analysis concluded

2019 Year 09 Month 30 Day


Other

Other related information

A patent application was filed on August 20, 2019 as "an enhancer for maintaining or enhancing the physical fitness of living by exercise". Japanese Patent Application 2019-150774


Management information

Registered date

2019 Year 05 Month 02 Day

Last modified on

2023 Year 05 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041733


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name