UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049876 |
|---|---|
| Receipt number | R000056776 |
| Scientific Title | Effects of processed diets on body weight, calorie intake, and metabolism: A prospective interventional study |
| Date of disclosure of the study information | 2022/12/23 |
| Last modified on | 2022/12/22 22:03:44 |
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Basic information
Public title
Effects of processed diets on body weight, calorie intake, and metabolism: A prospective interventional study
Acronym
Effects of processed diets on body weight, calorie intake, and metabolism
Scientific Title
Effects of processed diets on body weight, calorie intake, and metabolism: A prospective interventional study
Scientific Title:Acronym
Effects of processed diets on body weight, calorie intake, and metabolism
Region
| Japan |
Condition
Condition
Obesity
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the causal relationship of processed foods and body weight change.
Basic objectives2
Others
Basic objectives -Others
To elucidate the causal relationship of processed foods and calorie intake, metabolism.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Body weight change
Key secondary outcomes
Calorie intake
Metabolic markers
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
10 adults were randomized into two groups, 5 adults each.
Each group was exposed to ultra-processed and non-ultra-processed diets in random order for 7 days each, after a washout period of two weeks.
Interventions/Control_2
10 adults were randomized into two groups, 5 adults each.
Each group was exposed to ultra-processed and non-ultra-processed diets in random order for 7 days each, after a washout period of two 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
| 18 | years-old | <= |
Age-upper limit
| 40 | years-old | > |
Gender
Male
Key inclusion criteria
BMI 25 or over
Weight-stable (<+-5% over the past 6 months)
Not on regular hospital visits or medication
Key exclusion criteria
Those who have diabetes, dyslipidemia, hypertension, thyroid disease, cancer, anemia and eating disorders or other pshychiatric conditions such as depression or bipolar disorder.
Those who have food allergies or adherence to particular diets (e.g., vegetarian etc)
Any other subjects we considered not suitable for inclusion.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Naoto |
| Middle name | |
| Last name | Kubota |
Organization
The University of Tokyo Hospital
Division name
The Department of Diabetes and Metabolic Diseases
Zip code
113-8655
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
nkubota-tky@umin.org
Public contact
Name of contact person
| 1st name | Shoko |
| Middle name | |
| Last name | Hamano |
Organization
The University of Tokyo Hospital
Division name
The Department of Diabetes and Metabolic Diseases
Zip code
113-8655
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
Homepage URL
hamanos-int@h.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Terumo Life Science Foundation
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee, The University of Tokyo
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
Tel
03-5841-0818
ethics@m.u-tokyo.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
| 2022 | Year | 12 | Month | 23 | 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
10
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
| 2022 | Year | 07 | Month | 20 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 20 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 20 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 12 | Month | 22 | Day |
Last modified on
| 2022 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056776
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
