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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028799
Receipt No. 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

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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
Email 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
Email akinbo@tim.hi-ho.ne.jp

Sponsor
Institute Hokkaido University Graduate School
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032394

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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