Low Basal Body TemperatureNCT01399216
Effects of a Supplement Containing Fucoidan on Basal Body Temperature
A study testing Supplement containing fucoidan, EPA, and DHA in people with Low Basal Body Temperature, run by Hiroshima University at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Low Basal Body Temperature
- What is being tested?
- Supplement containing fucoidan, EPA, and DHA
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteJapan
- Study dates
- Jul 2011to Mar 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Low Basal Body Temperature
- Being tested
- Supplement containing fucoidan, EPA, and DHA, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supplement containing fucoidan, EPA, and DHADietary supplement
75 mg fucoidan per day, for 8 weeks
PlaceboDietary supplement
for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Fucoidan supplement | Experimental | Not described Receives: Dietary Supplement: Supplement containing fucoidan, EPA, and DHA |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Basal body temperature
Measured: up to 20 weeks
Secondary outcomes (1)
Change from baseline in serum lipid levels (total cholesterol, LDL cholesterol, HDL cholesterol, and triglyceride)
Measured: Weeks 0, 8, 12, and 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Basal Body TemperatureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hiroshima University
- Sponsor type
- University, hospital or other
- Collaborators
- Three Peace Co., Ltd., Japan
- Responsible party
- Principal investigator, Fumiko Higashikawa, Hiroshima University
- Investigators
- Fumiko Higashikawa, PhD, Principal investigator, Hiroshima University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01399216
- Sponsor's protocol ID
- eki-420
- Status last verified
- Dec 2012
- First submitted
- 19 Jul 2011
- Last updated
- 17 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Supplement Containing Fucoidan as a Major Component on Basal Body Temperature: a Placebo Controlled, Cross-over Study
- ClinicalTrials.gov ID
- NCT01399216
- Acronym / sponsor ID
- eki-420
- Conditions
- Low Basal Body Temperature
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Hiroshima UniversityUniversity, hospital or other
- Collaborators
- Three Peace Co., Ltd., Japan
- Study start
- Jul 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 21 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fucoidan supplement | Experimental | Dietary Supplement: Supplement containing fucoidan, EPA, and DHA |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 55 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supplement containing fucoidan, EPA, and DHA75 mg fucoidan per day, for 8 weeks | Dietary supplement | Fucoidan supplement |
| Placebofor 8 weeks | Dietary supplement | Placebo |
Primary outcome
Basal body temperature
Time frame: up to 20 weeks
1 secondary outcome
Change from baseline in serum lipid levels (total cholesterol, LDL cholesterol, HDL cholesterol, and triglyceride)
Time frame: Weeks 0, 8, 12, and 20
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2012.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fumiko Higashikawa, PhD principal investigator
Hiroshima University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supplement containing fucoidan, EPA, and DHA in people with Low Basal Body Temperature, run by Hiroshima University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Basal body temperature (time frame: up to 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2012.