Status:
WITHDRAWN
Absorption and Tolerability Studies of an Emulsion Containing the Coconut Oil-derived Glycerol Tridecanoate in Healthy Men
Lead Sponsor:
National University Hospital, Singapore
Conditions:
Polycystic Ovary Syndrome
Eligibility:
MALE
21-40 years
Phase:
PHASE1
Brief Summary
The primary aim of the study is to test safety and tolerance of oral intake of GT oil in the form of a non-diary based emulsion (10g of GT per emulsion) in healthy men. This will be a single center st...
Detailed Description
Polycystic Ovarian Syndrome (PCOS) is a hormonal disorder contributing to infertility in women. PCOS is also associated with Insulin resistance (IR) occurring at a high incidence rate of 50-70%. IR is...
Eligibility Criteria
Inclusion
- Men
- 21 - 40 years of age
- Healthy as determined by medical, physical examination and clinical laboratory results
- Weigh at least 60 kg.
- Reliable and willing to follow study procedures.
- Able to read/ understand English
- Given written informed consent approved by NUS and the Ethical Review Board governing the site.
Exclusion
- Known allergies to coconut oil, or related compounds,
- History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, haematological, or neurological disorders capable of significantly altering the absorption, or metabolism or elimination of drugs or of constituting a risk when taking the study medication or interfering with the interpretation of data.
- History of drug abuse
- Evidence of hepatitis B infection
- Given a blood donation of more than 450 mL in the last 3 months or any blood donation within the last month.
- Intend to use over-the counter or prescription medication known to affect reproductive or metabolic functions (e.g. hormonal pills, metformin and etc.) including steroidal preparations or intend to use vitamin, mineral, herbal or dietary supplements or intend to consume GT health supplements during the study
- Participants will be advised to avoid consuming coconut oil, or palm oil or any food products/ health supplements containing any of these oils during the study and 3 days prior to the study.
Key Trial Info
Start Date :
August 28 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 28 2018
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03255889
Start Date
August 28 2017
End Date
March 28 2018
Last Update
December 7 2017
Active Locations (1)
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1
Investigational Medicine Unit, National University Health System
Singapore, Singapore, 117599