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OpenTrials
Completed

NCT Number: NCT01399216

Effects of a Supplement Containing Fucoidan on Basal Body Temperature

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.

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Key information

Conditions

Low Basal Body Temperature

Age range

55 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hiroshima University

Hiroshima, 734-8551, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Supplement containing fucoidan, EPA, and DHA

Dietary Supplement

75 mg fucoidan per day, for 8 weeks

Placebo

Dietary Supplement

for 8 weeks

Primary outcomes

  1. Basal body temperature

    Time frame: up to 20 weeks

Secondary outcomes

  1. Change from baseline in serum lipid levels (total cholesterol, LDL cholesterol, HDL cholesterol, and triglyceride)

    Time frame: Weeks 0, 8, 12, and 20

Sponsors and collaborators

Lead sponsor

Hiroshima University

Other

Collaborators

  • Three Peace Co., Ltd., Japan

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jul 21, 2011
Registry last updated
Dec 17, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.