UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057255 |
|---|---|
| Receipt number | R000065448 |
| Scientific Title | Evaluation of the Effect of Dietary Time Intervention on Obese Japanese Adults with Elevated Blood Pressure and Grade I Hypertension |
| Date of disclosure of the study information | 2025/03/11 |
| Last modified on | 2026/03/16 08:39:17 |
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Basic information
Public title
Evaluation of the Effect of Dietary Time Intervention on Obese Japanese Adults with Elevated Blood Pressure and Grade I Hypertension
Acronym
Evaluation of the Effect of Dietary Time Intervention on Obese Japanese Adults with Elevated Blood Pressure and Grade I Hypertension
Scientific Title
Evaluation of the Effect of Dietary Time Intervention on Obese Japanese Adults with Elevated Blood Pressure and Grade I Hypertension
Scientific Title:Acronym
Evaluation of the Effect of Dietary Time Intervention on Obese Japanese Adults with Elevated Blood Pressure and Grade I Hypertension
Region
| Japan |
Condition
Condition
Obese Adults with Elevated Blood Pressure and Grade I Hypertension
Classification by specialty
| Medicine in general | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will conduct a randomized, group-based study in obese Japanese adults with elevated blood pressure and Grade I hypertension to test the effect that mealtime restriction has an effect in the Japanese population.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Weight change before and after intervention
Key secondary outcomes
Systolic and diastolic blood pressure, home blood pressure, triglyceride levels from fasting blood draw, total cholesterol, HDL cholesterol, LDL cholesterol, blood glucose, HbA1c, abdominal circumference, body composition from Inbody, bed and wake times from Fitbit, activity (steps), resting heart rate number, intestinal bacterial diversity, meal times, adherence to meal time interventions, dietary content, MCTQ Chronotype Questionnaire, PSQI Sleep Questionnaire, Time and Nutrition Questionnaire, IPAQ Physical Activity Questionnaire, WFun Presenteeism, PHQ-9 (anxiety, depression tendency), LEBA Light Exposure Behavior Rating Scale
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Maintain their normal meal times.
Interventions/Control_2
Eat 8-10 hours of meals per day.
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
| 40 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Age: 40 to 65 years old.
2. Daily meal time (time from the start of the first meal to the end of the last meal of the day) at the beginning of the study is at least 12 hours.
3. BMI over 25 kg/m2.
4. hose with high blood pressure (systolic blood pressure 130-139 mmHg or diastolic blood pressure 80-90 mmHg) or I degree hypertension (systolic blood pressure 140-159 mmHg or diastolic blood pressure 90-99 mmHg) and not II degree hypertension (systolic blood pressure 160 mmHg or more or 100 mmHg or more) (4) The patient must not have a blood pressure of more than 100 mmHg.
5. Those who are able to participate in the study period specified by us and visit the laboratory on the specified date.
6. You must be able to download and use a mobile application on your own cell phone.
Key exclusion criteria
(i) Those who currently have some underlying disease (excluding hypertension).
(ii) Those currently taking medications related to metabolism (including medications for hypertension).
(iii) Those currently taking supplements targeting weight loss, triglycerides, cholesterol, or blood sugar.
(iv) Those who have a history of weight management surgery.
(v) Currently participating in a weight loss or weight management program.
(vi) Is on a special or prescribed diet for any other reason.
(vii) Currently taking medications that target or are known to affect appetite.
(viii) Pregnant or lactating women.
(ix) Shift workers with variable work hours (e.g., night shifts).
(10) Caregivers of dependents (including infants) who require frequent nighttime care/sleep interruptions.
(11) Patients receiving CPAP treatment for sleep apnea syndrome, etc.
(12) Those who are planning to travel abroad to a country with a time difference of more than 3 hours during the study period.
(13) Those who have a moderate exercise habit of at least 75 minutes per week (examples of moderate exercise: jogging, mountain climbing, tennis, etc., but walking is not included. However, walking is not included). (Examples of moderate or vigorous exercise: jogging, mountain climbing, tennis, etc.).
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yu |
| Middle name | |
| Last name | Tahara |
Organization
Hiroshima University
Division name
Graduate School of Biomedical and Health Sciences
Zip code
734-0037
Address
Hiroshima-shi Kasumi 1-2-3, Hiroshima
TEL
082-257-5167
yutahara@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Yu |
| Middle name | |
| Last name | Tahara |
Organization
Hiroshima University
Division name
Graduate School of Biomedical and Health Sciences
Zip code
734-0037
Address
Hiroshima-shi Kasumi 1-2-3, Hiroshima
TEL
082-257-5167
Homepage URL
yutahara@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Hiroshima University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee for Clinical Research of Hiroshima University
Address
Kasumi 1-2-3, Hiroshima-shi, Hiroshima
Tel
082-257-1947
iryo-sinsa@office.hiroshima-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
広島大学
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 03 | Month | 11 | 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
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
| 2025 | Year | 03 | Month | 10 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 19 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 03 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | 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 | 03 | Month | 11 | Day |
Last modified on
| 2026 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065448
