Effects of a Supplement Containing Fucoidan on Basal Body Temperature

NCT ID: NCT01399216

Last Updated: 2012-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2012-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Low Basal Body Temperature

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Fucoidan supplement

Group Type EXPERIMENTAL

Supplement containing fucoidan, EPA, and DHA

Intervention Type DIETARY_SUPPLEMENT

75 mg fucoidan per day, for 8 weeks

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

for 8 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Supplement containing fucoidan, EPA, and DHA

75 mg fucoidan per day, for 8 weeks

Intervention Type DIETARY_SUPPLEMENT

Placebo

for 8 weeks

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Postmenopausal women with basal body temperature \< 36.0 ÂșC
* 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
Minimum Eligible Age

55 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Three Peace Co., Ltd., Japan

UNKNOWN

Sponsor Role collaborator

Hiroshima University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Fumiko Higashikawa

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Fumiko Higashikawa, PhD

Role: PRINCIPAL_INVESTIGATOR

Hiroshima University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hiroshima University

Hiroshima, , Japan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Japan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

eki-420

Identifier Type: -

Identifier Source: org_study_id