UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of Palmaria palmata on dyslipidemia and psychological stress - Randomized, double-blind, placebo-controlled parallel-group comparative study
Title of the study (Brief title)	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	Tatsuya Atsumi
Organization	Hokkaido University Graduate School
Division name	Department of Rheumatology, Endocrinology and Nephrology
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	Akinobu Nakamura
Organization	Hokkaido University Graduate School
Division name	Department of Rheumatology, Endocrinology and Nephrology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 08 Month 23 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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