UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028799 |
|---|---|
| Receipt number | R000032394 |
| Scientific Title | Effects of Palmaria palmata on dyslipidemia and psychological stress - Randomized, double-blind, placebo-controlled parallel-group comparative study |
| Date of disclosure of the study information | 2017/08/27 |
| Last modified on | 2017/12/22 11:54:39 |
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Basic information
Public title
Effects of Palmaria palmata on dyslipidemia and psychological stress - Randomized, double-blind, placebo-controlled parallel-group comparative study
Acronym
Effects of Palmaria palmata on dyslipidemia and psychological stress
Scientific Title
Effects of Palmaria palmata on dyslipidemia and psychological stress - Randomized, double-blind, placebo-controlled parallel-group comparative study
Scientific Title:Acronym
Effects of Palmaria palmata on dyslipidemia and psychological stress
Region
| Japan |
Condition
Condition
Dyslipidemia
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of Palmaria palmata on cholesterol and psychological stress in Japanese participants with dyslipidemia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
LDL cholesterol
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Administration of placebo twice daily for 8 weeks
Interventions/Control_2
Administration of Palmaria palmata (2g/day) twice daily for 8 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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Participants who are 20-year-old or older, and younger than 60-year-old at the time of obtaining informed consent
2)Participants whose fasting serum LDL colesterol levels are more than 120 mg/dL
3)Participants who can visit the medical institution according to schedule
4)Participants who are able to understand the study and willing to provide written informed consent
Key exclusion criteria
1)Participants whose fasting serum triglyceride levels are more than 400 mg/dL
2)Participants in pregnancy, lactation and scheduled pregnancy period
3)Participants who have made a blood donation within 2 (component blood donation), 4 (200mL), or 12 (400mL) weeks
4)Participants who are attending other studies or attended other studies within past 4 weeks
5)Participants with present heart, liver, kidney or thyroid disorders
6)Participants with a history of cardiac disorder
7)Participants with diabetes
8)Participants with allergy to the study foods
9)Participants who have been felt ill by blood collection
10)Participants with heavy use of alcohol
11)Participants with heavy smoking
12)Participants with irregular eating habits
13)Participants who are taking drugs, foods for specified health use or functional foods which could affect this study
14)Participants with a history of receiving a gastrointestinal surgery
15)Participants who are deemed to be unsuitable by the investigator
Target sample size
106
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tatsuya Atsumi |
Organization
Hokkaido University Graduate School
Division name
Department of Rheumatology, Endocrinology and Nephrology
Zip code
Address
N-15, W-7, Kita-ku, Sapporo, Hokkaido, Japan.
TEL
011-706-5915
at3tat@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akinobu Nakamura |
Organization
Hokkaido University Graduate School
Division name
Department of Rheumatology, Endocrinology and Nephrology
Zip code
Address
N-15, W-7, Kita-ku, Sapporo, Hokkaido, Japan
TEL
011-706-5915
Homepage URL
akinbo@tim.hi-ho.ne.jp
Sponsor or person
Institute
Hokkaido University Graduate School
Institute
Department
Personal name
Funding Source
Organization
Ministry of Agriculture, Forestry and Fisheries
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
Address
Tel
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
| 2017 | Year | 08 | Month | 27 | 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
| 2017 | Year | 08 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 10 | Month | 02 | Day |
Last follow-up date
| 2017 | Year | 11 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 23 | Day |
Last modified on
| 2017 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032394
