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Effects of a Supplement Containing Fucoidan on Basal Body Temperature

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ClinicalTrials.gov Identifier: NCT01399216
Recruitment Status : Completed
First Posted : July 21, 2011
Last Update Posted : December 17, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
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
Study Start Date : July 2011
Primary Completion Date : March 2012
Study Completion Date : March 2012

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

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

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

Eligibility Criteria

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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

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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 Posted: July 21, 2011    Key Record Dates
Last Update Posted: December 17, 2012
Last Verified: December 2012

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