UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032533
Receipt number R000037090
Scientific Title Effect of ingesting the beverages with different contents of carbohydrate and fat on exercise performance in the well-trained university students
Date of disclosure of the study information 2018/05/10
Last modified on 2019/11/10 12:58:36

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Basic information

Public title

Effect of ingesting the beverages with different contents of carbohydrate and fat on exercise performance in the well-trained university students

Acronym

Effect of ingesting the beverages with different contents of carbohydrate and fat on exercise performance

Scientific Title

Effect of ingesting the beverages with different contents of carbohydrate and fat on exercise performance in the well-trained university students

Scientific Title:Acronym

Effect of ingesting the beverages with different contents of carbohydrate and fat on exercise performance

Region

Japan


Condition

Condition

Normal

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effets of ingesting the beverages with different contents of carbohydrate and fat on exercise performance and insulin secretion in the well-trained university students.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

1.Stroop test during cycle ergometer exercise
2.Area under the curve for insulin level after ingestion of the test solution

Key secondary outcomes

1.Blood glucose levels after ingestion of the test solution
2.Glucose-dependent insulinotropic polypeptide (GIP)level after ingestion of the test solution
3.Rating of perceived exertion during cycle ergometer exercise


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

6

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Cycle ergometer exercise(30min,140-150bpm, stroop test)
>Blood sampling
>Ingestion of a test A solution(CHO 0.5g/kg body weight+250mL Water)
>Blood samplings(15,30,60,120min after ingestion)
>Cycle ergometer(30min, 140-150bpm, stroop test)
>Blood sampling.
All subjects will receive 6 treatments(test solution A-F) on 6 separate days over an interval of at least 6 days.

Interventions/Control_2

Cycle ergometer exercise(30min,140-150bpm, stroop test)
>Blood sampling
>Ingestion of a test B solution(CHO 0.5g/kg body weight+250mL Milk)
>Blood samplings(15,30,60,120min after ingestion)
>Cycle ergometer(30min, 140-150bpm, stroop test)
>Blood sampling.

Interventions/Control_3

Cycle ergometer exercise(30min,140-150bpm, stroop test)
>Blood sampling
>Ingestion of a test C solution(CHO 0.5g/kg body weight+250mL High fat milk)
>Blood samplings(15,30,60,120min after ingestion)
>Cycle ergometer(30min, 140-150bpm, stroop test)
>Blood sampling.

Interventions/Control_4

Cycle ergometer exercise(30min,140-150bpm, stroop test)
>Blood sampling
>Ingestion of a test D solution(CHO 1.0g/kg body weight+250mL Water)
>Blood samplings(15,30,60,120min after ingestion)
>Cycle ergometer(30min, 140-150bpm, stroop test)
>Blood sampling.

Interventions/Control_5

Cycle ergometer exercise(30min,140-150bpm, stroop test)
>Blood sampling
>Ingestion of a test E solution(CHO 1.0g/kg body weight+250mL Milk)
>Blood samplings(15,30,60,120min after ingestion)
>Cycle ergometer(30min, 140-150bpm, stroop test)
>Blood sampling.

Interventions/Control_6

Cycle ergometer exercise(30min,140-150bpm, stroop test)
>Blood sampling
>Ingestion of a test F solution(CHO 1.0g/kg body weight+250mL High fat milk)
>Blood samplings(15,30,60,120min after ingestion)
>Cycle ergometer(30min, 140-150bpm, stroop test)
>Blood sampling.

Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

18 years-old <=

Age-upper limit

24 years-old >=

Gender

Male and Female

Key inclusion criteria

Healthy university students who have th
e exercise habit and have given written i
nformed consent

Key exclusion criteria

Subjects
1)who have heart disease and/or respiratory disease and/or injury
2)who having take medicine
3)with food allergies
4)who having a smoking habit
5)who had a food-dependent exercise-induced anaphylaxis
6)who are judged as ineligible by the doctor for other reasons

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Michiyo
Middle name
Last name Kimura

Organization

Takasaki University of Health and Welfare

Division name

Health and Welfare

Zip code

3700033

Address

37-1, Nakaorui-machi, Takasaki city, Gunma, 370-0033, Japan

TEL

027-352-1290

Email

kimura@takasaki-u.ac.jp


Public contact

Name of contact person

1st name Michiyo
Middle name
Last name Kimura

Organization

Takasaki University of Health and Welfare

Division name

Health and Welfare

Zip code

3700033

Address

37-1, Nakaorui-machi, Takasaki city, Gunma, 370-0033, Japan

TEL

027-352-1290

Homepage URL


Email

kimura@takasaki-u.ac.jp


Sponsor or person

Institute

Takasaki University of Health and Welfare

Institute

Department

Personal name



Funding Source

Organization

Takasaki University of Health and Welfare

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Takasaki University of Health and Welfare

Address

37-1, Nakaorui-machi, Takasaki city, Gunma, 370-0033, Japan

Tel

027-352-1290

Email

mune@takasaki-u.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

2018 Year 05 Month 10 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications


Number of participants that the trial has enrolled

8

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

2018 Year 04 Month 03 Day

Date of IRB

2018 Year 05 Month 09 Day

Anticipated trial start date

2018 Year 05 Month 10 Day

Last follow-up date

2019 Year 03 Month 31 Day

Date of closure to data entry

2019 Year 11 Month 10 Day

Date trial data considered complete

2019 Year 11 Month 10 Day

Date analysis concluded

2019 Year 11 Month 10 Day


Other

Other related information



Management information

Registered date

2018 Year 05 Month 09 Day

Last modified on

2019 Year 11 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037090


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name