UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000058782
Receipt number R000067214
Scientific Title The effect of acute caffeine supplementation on fat oxidation during exercise in the fasted and fed state in overweight and untrained men
Date of disclosure of the study information 2025/08/14
Last modified on 2025/08/13 09:01:06

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Basic information

Public title

The effect of caffeine on fat oxidation in the fasted and fed state during exercise

Acronym

caffeine on fat oxidation

Scientific Title

The effect of acute caffeine supplementation on fat oxidation during exercise in the fasted and fed state in overweight and untrained men

Scientific Title:Acronym

effect of caffeine on fat oxidation during exercise in the fasted and fed state

Region

Asia(except Japan)


Condition

Condition

overweight and untrained men

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

compare the effect of acute caffeine supplementation on fat and carbohydrate metabolism before, during, and after exercise in fasted and fed states in overweight and untrained men.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase



Assessment

Primary outcomes

Fat oxidation, Carbohydrates metabolism and Resting Metabolism before exercise.
Fat oxidation, Carbohydrates metabolism and Energy Expenditure during exercise.
Fat oxidation, Carbohydrates metabolism and Resting Metabolism after exercise.




Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Cluster

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

4

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Food Other

Interventions/Control_1

participants ingested 5 mg of caffeine per kg of body weight in fasted . Each participant then performed 20 minutes of submaximal physical activity at 60% of their maximal oxygen consumption (VO2max).

Interventions/Control_2

participants ingested placebo in fasted. Each participant then performed 20 minutes of submaximal physical activity at 60% of their maximal oxygen consumption (VO2max).

Interventions/Control_3

participants ingested 5 mg of caffeine per kg of body weight in fed states. Each participant then performed 20 minutes of submaximal physical activity at 60% of their maximal oxygen consumption (VO2max).

Interventions/Control_4

participants ingested placebo in fed states. Each participant then performed 20 minutes of submaximal physical activity at 60% of their maximal oxygen consumption (VO2max).

Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

18 years-old <

Age-upper limit

30 years-old >

Gender

Male

Key inclusion criteria

being a male dormitory student,
being physically inactive (based on a questionnaire),
being overweight with a BMI greater than 25,
having no acute respiratory problems, asthma, lower body mobility issues or injuries, and not having any specific metabolic diseases or consuming medication and performance-enhancing supplements.

Key exclusion criteria

a participant's unwillingness to continue at any stage of the test,
consumption of any tobacco or alcohol,
experiencing any symptoms of headache, dizziness, or weakness during the test,
failure to complete the testing period,
sensitivity to caffeine consumption,
consuming any calorie-containing food during fasting sessions.

Target sample size

19


Research contact person

Name of lead principal investigator

1st name adel
Middle name
Last name donyaei

Organization

Shahrood University Of Technology

Division name

Physical Education and Sport Sciences

Zip code

3619995161

Address

Shahrood, Haft Tir Square, Shahrood University of Technology

TEL

098-2332395900

Email

adelldonyai@yahoo.com


Public contact

Name of contact person

1st name ali
Middle name
Last name akbari

Organization

Shahrood University Of Technology

Division name

Physical Education and Sport Sciences

Zip code

3619995161

Address

Shahrood, Haft Tir Square, Shahrood University of Technology

TEL

098-2332395900

Homepage URL


Email

adelldonyai@yahoo.com


Sponsor or person

Institute

Shahrood University Of Technology

Institute

Department

Personal name



Funding Source

Organization

Shahrood University Of Technology

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Research Ethics Committee of Shahrood University of Technology

Address

Shahrood, Haft Tir Square, Shahrood University of Technology, Faculty of Physical Education and Sport Sciences

Tel

098-2332395900

Email

Ethics.C@shahroodut.ac.ir


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

2025 Year 08 Month 14 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

19

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

2024 Year 08 Month 18 Day

Date of IRB

2024 Year 08 Month 25 Day

Anticipated trial start date

2024 Year 10 Month 20 Day

Last follow-up date

2024 Year 11 Month 19 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2025 Year 08 Month 13 Day

Last modified on

2025 Year 08 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067214