Clinical trial NCT03255889: Absorption and Tolerability Studies of an Emulsion Containing the Coconut Oil-derived Glycerol Tridecanoate in Healthy Men
Official title: Absorption and Tolerability Studies of an Emulsion Containing the Coconut Oil-derived Glycerol Tridecanoate in Healthy Men
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Polycystic Ovary Syndrome
Keywords: Safety
Tolerability
Pharmacokinetics
Absorption
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
First posted: 2017-08-21
Enrollment: 0
Sex: MALE
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 study, and the recruitment is expected to happen over a 1-2- month's period.

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 a condition in which your body loses sensitivity to insulin requiring higher levels of it to maintain normal glucose levels in blood which hormones production from ovaries. Studies have demonstrated that the prevalence of the metabolic syndrome which is a cluster of condition such as increased blood pressure, high blood sugar, excess body fat around the waist, and abnormal cholesterol in women with PCOS is significantly higher than that of the general population. Medications that improve insulin sensitivity, such as thiazolidinediones (TZDs) and Metformin, an insulin sensitizer have been used in treating women with PCOS. Metformin major side effects consist of nausea, vomiting and gastrointestinal distress. TZDs are withdrawn from the market due to their adverse effect profile, which includes liver toxicity, weight gain, swelling due to water retention and cardiovascular diseases. As current treatment options are inadequate, there is a clinical need to identify new treatment regimens with a reduced adverse effect profile to improve the management of PCOS and its related metabolic syndrome.

Glyceryl Tridecanoate (GT) is a medium chain triglyceride (MCT); a form of dietary fat, which has a long history of safe use in in foods, drugs, cosmetics, can even be provided via the veins in individuals requiring supplemental nutrition. Decanoic acid, also known as capric acid, occurs naturally in coconut oil (8 - 10%) and palm kernel oil (4%). Importantly, the published findings show that oral administration of GT, the triglyceride form of decanoic acid, can improve insulin sensitivity and storage and breakdown of fat in animal models of diabetes. Notably, in the investigators' recent findings, DA could reduce androgen production and alleviate PCOS like symptoms in a test-induced PCOS rat model. Hence, there is a high likelihood that GT can improve the management of PCOS without the undesirable side effects that are observed with the thiazolidinediones.

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 study, and the recruitment is expected to happen over a 1-2- month's period.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Incidence and severity of adverse events/severe events
timeFrame: 8 to 10 days
Secondary outcomes:
measure: Decanoic acid
timeFrame: 3 months
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Investigational Medicine Unit, National University Health System
Study officials:
affiliation: National University Hospital, Singapore
name: Eu Leong Yong, MD & PhD
role: PRINCIPAL_INVESTIGATOR
References: