Effects of a Supplement Containing Fucoidan on Basal Body... | NCT01399216

Studies
Effects of a Supplement Containing Fucoidan on Basal Body Temperature

NCT01399216

Sponsor

Hiroshima University

Status

Completed

Last Update Posted

Dec 17, 2012Estimated

Enrollment

19Actual

Phase

Not Applicable

Conditions

Low Basal Body Temperature

Interventions

Supplement containing fucoidan, EPA, and DHA
Placebo

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2011

Primary Completion Date

Mar 2012Actual

Completion Date

Mar 2012Actual

First Submitted Date

Jul 19, 2011

First Submission Date that Met QC Criteria

Jul 20, 2011

First Posted Date

Jul 21, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 13, 2012

Last Update Posted Date

Dec 17, 2012Estimated

Name	Class
Three Peace Co., Ltd., Japan	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

We aim to determine whether a supplement containing fucoidan isolated from Mekabu (sporophyll of Undaria pinnatifida), EPA, and DHA has effects of elevating basal body temperature in subjects with low basal body temperature.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

19Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Fucoidan supplement	Experimental		Dietary Supplement: Supplement containing fucoidan, EPA, and DHA
Placebo	Placebo Comparator		Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Supplement containing fucoidan, EPA, and DHA	Dietary Supplement	75 mg fucoidan per day, for 8 weeks	Fucoidan supplement

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Basal body temperature		up to 20 weeks

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline in serum lipid levels (total cholesterol, LDL cholesterol, HDL cholesterol, and triglyceride)		Weeks 0, 8, 12, and 20

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Postmenopausal women with basal body temperature < 36.0 ºC
Healthy as based on medical history and physical examination
Willing not to donate blood during the study
Informed consent signed

Exclusion Criteria:

Renal or hepatic dysfunction
Heart disease
Participation in any clinical trial within 90 days of the commencement of the trial
Subjects who are taking medicines or functional food that may affect basal body temperature

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Fumiko Higashikawa, PhD	Hiroshima University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hiroshima University		Hiroshima		734-8551	Japan