Effects of a Supplement Containing Fucoidan on Basal Body Temperature

Not Applicable

Completed

• Conditions: Low Basal Body Temperature
• Interventions: Dietary Supplement: Supplement containing fucoidan, EPA, and DHA; Dietary Supplement: Placebo

• Registration Number: NCT01399216
• Lead Sponsor: Hiroshima University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-07-19
• Study First Submitted QC: 2011-07-20
• Study First Posted: 2011-07-21
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-13
• Last Update Posted: 2012-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Fucoidan supplement	Supplement containing fucoidan, EPA, and DHA	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Basal body temperature	up to 20 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hiroshima University; 🇯🇵 Hiroshima, Japan