Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Syndrome

Polycystic Ovary Syndrome

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

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Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

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Glycerol

Decanoic acid

Coconut

Sunflower

Glyceryl Tridecanoate emulsion, single doses (5 g, 10 g, 20 g) to 3 cohorts

Sunflower oil emulsion, single doses (5 g, 10 g, 20 g) to 3 cohorts

Glyceryl Tridecanoate (GT) is the triglyceride form of decanoic acid (DA), a C10 fatty acid. GT belongs to the class of medium chain triglycerides (MCT), which has been accepted as a Generally Recognized As Safe food product by FDA. Decanoic acid, also known as capric acid, occurs naturally in coconut oil (8 - 10%) and palm kernel oil (4%).

Glyceryl Tridecanoate

Sunflower oil emulsion of equal calories.

Placebo

Eu Leong Yong, MD & PhD

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.

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 TZDs are withdrawn from the market due to their adverse effect profile, which includes liver toxicity, weight gain, swelling due to water retention and cardiovascular diseases.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.

Absorption and Tolerability Studies of an Emulsion Containing the Coconut Oil-derived Glycerol Tridecanoate in Healthy Men

Incidence and severity of adverse events/serious adverse events based on history, physical examination and vital signs and clinical chemistry

Serum will be extracted from blood samples for measurement of decanoic acid using gas chromatography-mass spectrometry (GC/MS)

National University Hospital, Singapore

Professor

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Absorption and Tolerability Studies of an Emulsion Containing the Coconut Oil-derived Glycerol Tridecanoate in Healthy Men	NCT03255889	Polycystic Ovar...	Glyceryl Tridec... Placebo	21 Years - 40 Years	National University Hospital, Singapore
Absorption and Tolerability Studies of an Emulsion Containing the Coconut Oil-derived Glycerol Tridecanoate in Healthy Men	NCT03255889	Polycystic Ovar...	Glyceryl Tridec... Placebo	21 Years - 40 Years	National University Hospital, Singapore

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