UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040782 |
|---|---|
| Receipt number | R000044880 |
| Scientific Title | Effects of exercise and food with health claims intake on carbohydrate, lipid and energy metabolism |
| Date of disclosure of the study information | 2020/06/16 |
| Last modified on | 2023/12/19 21:11:27 |
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Basic information
Public title
Effects of exercise and food with health claims intake on carbohydrate, lipid and energy metabolism
Acronym
Metabolism of food with health claims intake during exercise
Scientific Title
Effects of exercise and food with health claims intake on carbohydrate, lipid and energy metabolism
Scientific Title:Acronym
Metabolism of food with health claims intake during exercise
Region
| Japan |
Condition
Condition
healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to clarify the effect of food with health claims on carbohydrate and lipid metabolism during exercise
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
Carbohydrate oxidation, Lipid oxidation
Key secondary outcomes
Energy expenditure, Respiratory quotient, Heart rate, Blood pressure, VO2, VCO2
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
Intake of beverage with food with health claims or sugar
Interventions/Control_2
30-min treadmill exercise at 50-60% VO2max
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
| 18 | years-old | <= |
Age-upper limit
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
healthy adults
Key exclusion criteria
1) BMI<18.5 or >=25
2) smoker
3) taking medicine
4) pregnancy
5) subjects judged by the investigator to be ineligible for other reasons
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | daisuke |
| Middle name | |
| Last name | shindo |
Organization
School of Pharmacy, Nihon University
Division name
Laboratory of Health and sports Science
Zip code
274-8555
Address
7-7-1 Narashinodai, Funabashi-shi, Chiba
TEL
047-465-5827
shindo.daisuke@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | daisuke |
| Middle name | |
| Last name | shindo |
Organization
School of Pharmacy, Nihon University
Division name
Laboratory of Health and sports Science
Zip code
274-8555
Address
7-7-1 Narashinodai, Funabashi-shi, Chiba
TEL
047-465-5827
Homepage URL
shindo.daisuke@nihon-u.ac.jp
Sponsor or person
Institute
School of Pharmacy, Nihon University
Institute
Department
Personal name
Funding Source
Organization
Mitsui Sugar Co., Ltd
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
School of Sports Science, Nihon University
Showa Women's University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
School of Pharmacy, Nihon University
Address
7-7-1 Narashinodai, Funabashi-shi, Chiba
Tel
047-465-5827
shindo.daisuke@nihon-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
日本大学薬学部（千葉県）
日本大学スポーツ科学部（東京都）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 06 | Month | 16 | Day |
Related information
URL releasing protocol
ISSN:0918-2276
Publication of results
Published
Result
URL related to results and publications
ISSN:0918-2276
Number of participants that the trial has enrolled
15
Results
Pre-exercise consumption of carbohydrate, which is recognised as an ingredient in Foods for Specified Health Use (Foods that do not cause tooth decay), increased energy expenditure at rest before exercise and reduced dependence on carbohydrate oxidation before and during exercise.
Results date posted
| 2023 | Year | 12 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Healthy young men and women with no daily exercise routine.
No chronic diseases
No smoking habits.
No menstrual abnormalities in women
Participant flow
Participants arrived at the laboratory at around 9:00 am and were first checked to ensure that their physical condition and medication status were satisfactory for the day. Electrocardiogram electrodes were then fitted. Next, heart rate and blood pressure were measured in a chair rest position, followed by measurement of oxygen uptake and carbon dioxide emissions (Baseline measurements) for 5 min wearing a mask for breath sampling.) The subjects were then asked to consume a beverage (500 ml) containing one of the three types of isomaltulose, sucrose or water in about 10 min, with 0 min set as the time when they finished drinking the beverage. After 60 min had elapsed since the consumption of the drink, the participants performed treadmill exercise for 30 min at a speed corresponding to 50-60% of the VO2max measured in the preliminary experiment. After the exercise, the subjects again maintained chair rest for 60 min, and the experiment was terminated with a final measurement at 150 min. The participants were instructed to refrain from using electronic devices such as smartphones and PCs during chair rest.
Adverse events
nothing
Outcome measures
Heart rate, blood pressure, oxygen intake, carbon dioxide emissions, energy expenditure, carbohydrate oxidation rate, lipid oxidation rate
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 02 | Month | 20 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 13 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 20 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 15 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 06 | Month | 16 | Day |
Last modified on
| 2023 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044880
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