UMIN-CTR Clinical Trial

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
Email	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
Email	midori.matayoshi@glico.com

Sponsor
Institute	EZAKI GLICO Co., Ltd.
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000052564