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

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 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

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

Value
https://center6.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