UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050463 |
|---|---|
| Receipt number | R000057481 |
| Scientific Title | A randomized comparative study on the efficacy of web-based comprehensive nutritional intervention in patients with either MetS or pre-MetS |
| Date of disclosure of the study information | 2023/03/01 |
| Last modified on | 2023/03/01 19:05:06 |
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Basic information
Public title
Evaluating the efficacy of web-based nutritional intervention in patients with either metabolic syndrome (MetS) or pre-MetS
Acronym
A study on the effects of web-based nutrition
Scientific Title
A randomized comparative study on the efficacy of web-based comprehensive nutritional intervention in patients with either MetS or pre-MetS
Scientific Title:Acronym
A web-based nutritional study in patients with either MetS or pre-MetS
Region
| Japan |
Condition
Condition
MetS and pre-MetS
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficacy of web-based comprehensive nutritional intervention in patients with either MetS or pre-MetS
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of weight loss of 3% or more at week 24
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Comprehensive nutritional counseling: provide the session at our hospital
Interventions/Control_2
Comprehensive nutritional counseling: provide the session at home
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
| 30 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male
Key inclusion criteria
Either MetS or pre-MetS in the department of Cardiology at Fukuoka University Hospital
Key exclusion criteria
1 Heart failure (NYHA class 3 or 4)
2 Stage 4 or 5 chronic kidney disease
3 Daily alcohol consumption of 30 g or more
4 Hepatitis B or C virus
5 Active cancer
6 Major operation or major cardiovascular event within the past 6 months
7 Treated infectious disease
8 Taking any of the following therapeutic agents (insulin, steroids, and anti-obesity treatments)
9 Weight loss of 5 percent or more within the past 6 months
10 Nutritional counseling within the past 6 months
11 Taking supplements for weight loss daily
12 Without home high-speed internet access
13 Any of the following implantable cardiac devices: cardiac pacemaker, implantable cardioverter defibrillators, and cardiac resynchronisation therapy
14 Inappropriate cases deemed by the physician
Target sample size
78
Research contact person
Name of lead principal investigator
| 1st name | Kohei |
| Middle name | |
| Last name | Takata |
Organization
Fukuoka University Hospital
Division name
Department of Cardiology and Clinical Laboratory
Zip code
8140180
Address
7-45-1 Nanakuma, Jonan-ku, Fukuoka City, Fukuoka, Japan
TEL
092-801-1011
k.takata.jp@adm.fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | Kohei |
| Middle name | |
| Last name | Takata |
Organization
Fukuoka University Hospital
Division name
Department of Cardiology and Clinical Laboratory
Zip code
8140180
Address
7-45-1 Nanakuma, Jonan-ku, Fukuoka City, Fukuoka, Japan
TEL
092-801-1011
Homepage URL
k.takata.jp@adm.fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka University Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research and Ethics Center, Fukuoka University School of Medicine
Address
7-45-1 Nanakuma, Jonan-ku, Fukuoka City, Fukuoka, Japan
Tel
092-801-1011
fumed-ethics@fukuoka-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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 03 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 01 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 04 | Month | 10 | Day |
Last follow-up date
| 2025 | 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
| 2023 | Year | 03 | Month | 01 | Day |
Last modified on
| 2023 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057481
