UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024195 |
|---|---|
| Receipt number | R000027853 |
| Scientific Title | Observational study of combination of food intake on serum lipid concentration |
| Date of disclosure of the study information | 2016/10/01 |
| Last modified on | 2023/04/03 11:47:42 |
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Basic information
Public title
Observational study of combination of food intake on serum lipid concentration
Acronym
Combination of food intake on serum lipid concentration
Scientific Title
Observational study of combination of food intake on serum lipid concentration
Scientific Title:Acronym
Combination of food intake on serum lipid concentration
Region
| Japan |
Condition
Condition
dyslipidemia
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the protective diet for dyslipidemia, desirable combination of foods are studied.
Basic objectives2
Others
Basic objectives -Others
Effects of cholesterol-rich foods intake on serum LDL-cholesterol concentration are assessed.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Serum LDL-cholesterol concentration
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Japanese
Key exclusion criteria
Supplement or health food user
Athlete
Pregnant
Patient under medical treatment
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Chizuko |
| Middle name | |
| Last name | Maruyama |
Organization
Japan Women's University
Division name
Department of Food and Nutrition, Faculty of Human Sciences and Design
Zip code
112-8681
Address
2-8-1, Mejirodai, Bunkyo-ku, Tokyo
TEL
81-3-5981-3274
maruyama@fc.jwu.ac.jp
Public contact
Name of contact person
| 1st name | Maruyama |
| Middle name | |
| Last name | Chizuko |
Organization
Japan Women's University
Division name
Clinical Nutrition Education Laboratory, Japan Women's University
Zip code
112-8681
Address
2-8-1, Mejirodai, Bunkyo-ku, Tokyo
TEL
03-5981-3428
Homepage URL
maruyama@fc.jwu.ac.jp
Sponsor or person
Institute
Clinical Nutrition Education Laboratory,
Japan Women's University
Institute
Department
Personal name
Funding Source
Organization
Kieikai of the Nakashima foundation and
Japan Women's University
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethic's Commitee of Japan Women's University
Address
2-8-1, Mejirodai, Bunkyo-ku, Tokyo
Tel
03-5981-3773
n-shien@atlas.jwu.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
| 2016 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
The protocol was not released.
Publication of results
Unpublished
Result
URL related to results and publications
https://doi.org/10.3390/nu14122442
Number of participants that the trial has enrolled
213
Results
From the short FFQ, the traditional Japanese (TJ) pattern (greater intakes of vegetables, seaweed/mushrooms/konjac, dairy, fruits, fish, salty, and soybeans/soy products) and the Westernized pattern (greater intakes of saturated-fat-rich foods, oily, egg/fish-eggs/liver, and sweets) were identified. The TJ pattern score showed an inverse relationship with BMI, TG, ALP, LAP, and fatty liver index.
Results date posted
| 2023 | Year | 04 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
198 (96 men and 102 women) subjects were included in all analyses. Study participants who worked full time accounted for 85.4% of men and 67.6% of women, and 10.8% of the women were housewives. The proportions with obesity were 21% in men and 6% in women. Hypertriglyceridemia was significant only in men, affecting 26%.
Participant flow
Japanese residents of Tokyo and surrounding districts, 20 to 49 years of age, were recruited to participate in this study by poster, leaflet and e-mail from September 2016 to October 2018. Patients taking medications, those who were pregnant, nursing women, those engaged in high-intensity exercise, and individuals habitually consuming dietary supplements or functional foods were excluded. Participants were asked to keep three-day (two weekdays and one weekend day) dietary records during the week just before the examinations. Anthropometric measurements and fasting blood collection were conducted at Japan Women's University in the morning following an at least 12 h fast.　The very short food intake frequency questionnaire named "Plus1Minus1", designed for assessment and evaluation in nutrition education practice by Maruyama et al., was used.
Adverse events
None.
Outcome measures
BMI, umbilical circumference, blood pressure, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, triglyceride, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, leucine aminopeptidase, gamma-glutamyl transpeptidase, total bilirubin, and direct bilirubin, and the "fatty liver index".
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2016 | Year | 09 | Month | 12 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 18 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 20 | Day |
Last follow-up date
| 2018 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The relations between consumption volume of foods and serum lipid concentration are assessed.
Management information
Registered date
| 2016 | Year | 09 | Month | 27 | Day |
Last modified on
| 2023 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027853
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| Registered date | File name |
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