UMIN-CTR Clinical Trial

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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000050719