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Effects of a Supplement Containing Fucoidan on Basal Body Temperature

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01399216
First Posted: July 21, 2011
Last Update Posted: December 17, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Three Peace Co., Ltd., Japan
Information provided by (Responsible Party):
Fumiko Higashikawa, Hiroshima University
  Purpose
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.

Condition Intervention
Low Basal Body Temperature Dietary Supplement: Supplement containing fucoidan, EPA, and DHA Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of a Supplement Containing Fucoidan as a Major Component on Basal Body Temperature: a Placebo Controlled, Cross-over Study

Resource links provided by NLM:


Further study details as provided by Fumiko Higashikawa, Hiroshima University:

Primary Outcome Measures:
  • Basal body temperature [ Time Frame: up to 20 weeks ]

Secondary Outcome Measures:
  • Change from baseline in serum lipid levels (total cholesterol, LDL cholesterol, HDL cholesterol, and triglyceride) [ Time Frame: Weeks 0, 8, 12, and 20 ]

Enrollment: 19
Study Start Date: July 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fucoidan supplement Dietary Supplement: Supplement containing fucoidan, EPA, and DHA
75 mg fucoidan per day, for 8 weeks
Placebo Comparator: Placebo Dietary Supplement: Placebo
for 8 weeks

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01399216


Locations
Japan
Hiroshima University
Hiroshima, Japan, 734-8551
Sponsors and Collaborators
Hiroshima University
Three Peace Co., Ltd., Japan
Investigators
Principal Investigator: Fumiko Higashikawa, PhD Hiroshima University
  More Information

Responsible Party: Fumiko Higashikawa, Associate Professor, Hiroshima University
ClinicalTrials.gov Identifier: NCT01399216     History of Changes
Other Study ID Numbers: eki-420
First Submitted: July 19, 2011
First Posted: July 21, 2011
Last Update Posted: December 17, 2012
Last Verified: December 2012

Additional relevant MeSH terms:
Fucoidan
Anti-Ulcer Agents
Gastrointestinal Agents
Anticoagulants
Antineoplastic Agents