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Clinical Trials/NCT01399216
NCT01399216CompletedNot Applicable

Effects of a Supplement Containing Fucoidan as a Major Component on Basal Body Temperature: a Placebo Controlled, Cross-over Study

Hiroshima University2 sites in 1 country19 target enrollmentStarted: July 2011Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
19
Locations
2
Primary Endpoint
Basal body temperature
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Prevention
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
55 Years to 70 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

Basal body temperature

Time Frame: up to 20 weeks

Secondary Outcomes

  • Change from baseline in serum lipid levels (total cholesterol, LDL cholesterol, HDL cholesterol, and triglyceride)(Weeks 0, 8, 12, and 20)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Fumiko Higashikawa

Associate Professor

Hiroshima University

Study Sites (2)

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