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
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
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
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
