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

July 19, 2011
December 13, 2012
July 2011
March 2012   (final data collection date for primary outcome measure)
Basal body temperature [ Time Frame: up to 20 weeks ] [ Designated as safety issue: No ]
Basal body temperature [ Time Frame: 8 weeks (Overall 20 weeks) ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01399216 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Effects of a Supplement Containing Fucoidan on Basal Body Temperature
Effects of a Supplement Containing Fucoidan as a Major Component on Basal Body Temperature: a Placebo Controlled, Cross-over Study

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Low Basal Body Temperature
  • Dietary Supplement: Supplement containing fucoidan, EPA, and DHA
    75 mg fucoidan per day, for 8 weeks
  • Dietary Supplement: Placebo
    for 8 weeks
  • Experimental: Fucoidan supplement
    Intervention: Dietary Supplement: Supplement containing fucoidan, EPA, and DHA
  • Placebo Comparator: Placebo
    Intervention: Dietary Supplement: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
19
March 2012
March 2012   (final data collection date for primary outcome measure)

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
Female
55 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01399216
eki-420
No
Fumiko Higashikawa, Hiroshima University
Hiroshima University
Three Peace Co., Ltd., Japan
Principal Investigator: Fumiko Higashikawa, PhD Hiroshima University
Hiroshima University
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP