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Effects of a Supplement Containing Fucoidan on Basal Body Temperature

This study has been completed.
Sponsor:
Collaborator:
Three Peace Co., Ltd., Japan
Information provided by (Responsible Party):
Fumiko Higashikawa, Hiroshima University
ClinicalTrials.gov Identifier:
NCT01399216
First received: July 19, 2011
Last updated: December 13, 2012
Last verified: December 2012
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

Further study details as provided by Hiroshima University:

Primary Outcome Measures:
  • Basal body temperature [ Time Frame: up to 20 weeks ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   55 Years to 70 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Fumiko Higashikawa, Associate Professor, Hiroshima University
ClinicalTrials.gov Identifier: NCT01399216     History of Changes
Other Study ID Numbers: eki-420
Study First Received: July 19, 2011
Last Updated: December 13, 2012
Health Authority: Japan: Institutional Review Board

Additional relevant MeSH terms:
Fucoidan
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
 Pharmacologic Actions
Anticoagulants
Hematologic Agents
Antineoplastic Agents

ClinicalTrials.gov processed this record on June 18, 2013