UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044402 |
|---|---|
| Receipt number | 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 | 2022/10/23 13:12:31 |
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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
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
m.miyashita@waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
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
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
Completed
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
| 2022 | Year | 10 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050719
