UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046053 |
|---|---|
| Receipt number | R000052564 |
| Scientific Title | Preliminary study to evaluate the constitutional improvement by synergistic effect of low-carbohydrate diet and exercise |
| Date of disclosure of the study information | 2021/11/12 |
| Last modified on | 2022/07/19 15:43:39 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Preliminary study to evaluate the constitutional improvement by synergistic effect of low-carbohydrate diet and exercise
Acronym
Preliminary study to evaluate the constitutional improvement by synergistic effect of low-carbohydrate diet and exercise
Scientific Title
Preliminary study to evaluate the constitutional improvement by synergistic effect of low-carbohydrate diet and exercise
Scientific Title:Acronym
Preliminary study to evaluate the constitutional improvement by synergistic effect of low-carbohydrate diet and exercise
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the effectiveness of constitutional improvement and blood component by synergistic effect of low-carbohydrate diet and exercise for 4weeks.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Total cholesterol, LDL, HDL cholesterol, triglycerides, glucose, HbA1c
Body fat, Muscle mass, BMI, Physical ability
Key secondary outcomes
Meal record, Physical condition questionnaire
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
Eat a low-carbohydrate lunch and snack for 4 weeks
Interventions/Control_2
Carry out exercise (walking, stretching, and strength training)for 4 weeks
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
| 25 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Person who meet either or both of the following conditions, and who meet similar conditions
-BMI>=25.0
-Body fat
Male:15.0-24.9%
Famale:25.0-34.9%
2.Persons who can voluntarily consent to participate in the study by consent form
Key exclusion criteria
1.Person who have an irregular diet on a daily basis (eg, there are many shortages and no extremely unbalanced diet)
2.Person who cannot continuously perform the designated exercise (walking, stretching, and strength training) due to physical condition and other reason on the study period.
3.People who may change their eating habits and lifestyle on the study period (eg, long-term travel.)
4.Person who may have food allergic symptoms to the test food, and those who may have serious allergic symptoms to other foods and pharmaceuticals.
5.Person who have a disease under treatment or who have a history of serious illness requiring medication
6.Person who are judged to be inappropriate by preliminary inspection.
7.Person who are participating in other tests that take foods or use drugs
8.Person who are pregnant, breastfeeding or willing to breastfeed on the study period.
9.Person who is judged by his/her doctor to be inappropriate as a subject
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Iizuka |
Organization
hiroyuki.iizuka@glico.com
Division name
R&D LABORATORY
Zip code
555-8502
Address
4-6-5, Utajima, NIshiyodogawa-ku, Osaka,Japan
TEL
+81-6-6477-8793
hiroyuki.iizuka@glico.com
Public contact
Name of contact person
| 1st name | Midori |
| Middle name | |
| Last name | Matayoshi |
Organization
EZAKI GLICO Co., Ltd
Division name
R&D LABORATORY
Zip code
555-8502
Address
4-6-5, Utajima, NIshiyodogawa-ku, Osaka,Japan
TEL
+81-6-6477-8793
Homepage URL
midori.matayoshi@glico.com
Sponsor or person
Institute
EZAKI GLICO Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
EZAKI GLICO Co., Ltd.
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
The Institutional Review Board of Glico Group
Address
2-4, Komatsubara-cho, Kita-ku, Osaka, Japan
Tel
+81-6-6477-8793
toshihiko.koike@glico.com
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 | 11 | Month | 12 | 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
16
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
| 2021 | Year | 06 | Month | 28 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 28 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 07 | Day |
Last follow-up date
| 2022 | Year | 01 | Month | 30 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 15 | Day |
Date trial data considered complete
| 2022 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2022 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 11 | Month | 12 | Day |
Last modified on
| 2022 | Year | 07 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052564
