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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044402
Receipt No. R000050719
Scientific Title Acute synergistic effects of exercise and polyphenol on postprandial glucose metabolism in older adults
Date of disclosure of the study information 2021/06/04
Last modified on 2021/06/02

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Basic information
Public title Synergistic effects of exercise and polyphenol on postprandial glucose metabolism in older adults
Acronym Effects of exercise and polyphenol on glucose metabolism
Scientific Title Acute synergistic effects of exercise and polyphenol on postprandial glucose metabolism in older adults
Scientific Title:Acronym Effects of exercise combined with polyphenol on glucose metabolism in older adults
Region
Japan

Condition
Condition Adult
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effects of polyphenol on glucose tolerance in elderly women by evaluating postprandial glucose metabolism after consuming polyphenol-containing drink and exercise.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Blood glucose
Key secondary outcomes Anthropometry, blood pressure, other blood lipid and carbohydrate parameters, and hormonal markers

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food Behavior,custom
Interventions/Control_1 Participants consume a standardised meal with a test drink followed by walking. Blood samples are taken to evaluate biochemical and hormonal markers.
Interventions/Control_2 Participants consume a standardised meal with a placebo drink followed by walking. Blood samples are taken to evaluate biochemical and hormonal markers.
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 Female
Key inclusion criteria - Age between 65 and 75 years old
- A participant who had an Hb-A1c of 5.6% or higher noted in a medical checkup or blood draw in the past six months.
- Not taking any medications and dietary supplements
- No surgical diseases
- No smoker
- A participant who performed weight changes plus or minus 3 kg in the past three months and who has no intention to weight loss during the study.
- A participant who can consume the test food in the study.
Key exclusion criteria - Not age between 64 and 76 years old
- A participant who did not have an Hb-A1c of 5.6% or higher noted in a medical checkup or blood draw in the past six months.
- A participant who takes medications and dietary supplements
- A participant who has surgical diseases
- Smoker
- A participant who performed weight changes plus or minus 3 kg in the past three months and who has an intention to weight loss during the study.
- A participant who cannot consume the test food in the study.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Masashi
Middle name
Last name Miyashita
Organization Waseda University
Division name Faculty of Sport Sciences
Zip code 359-1192
Address 2-579-15 Mikajima, Tokorozawa, Saitama
TEL 04-2947-6774
Email m.miyashita@waseda.jp

Public contact
Name of contact person
1st name Masashi
Middle name
Last name Miyashita
Organization Waseda University
Division name Faculty of Sport Sciences
Zip code 359-1192
Address 2-579-15 Mikajima, Tokorozawa, Saitama
TEL 04-2947-6774
Homepage URL
Email m.miyashita@waseda.jp

Sponsor
Institute Waseda University
Institute
Department

Funding Source
Organization Kao 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 Waseda University
Address 1-104 Totsuka-cho, Shinjuku-ku, Tokyo
Tel 03-5272-1639
Email rinri@list.waseda.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
2021 Year 06 Month 04 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 Preinitiation
Date of protocol fixation
2020 Year 03 Month 30 Day
Date of IRB
2021 Year 06 Month 01 Day
Anticipated trial start date
2021 Year 06 Month 05 Day
Last follow-up date
2022 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 06 Month 02 Day
Last modified on
2021 Year 06 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050719

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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