Clinical trial · Interventional
Absorption and Tolerability Studies of an Emulsion Containing the Coconut Oil-derived Glycerol Tridecanoate in Healthy Men
NCT03255889CI-TRIAL-00030719withdrawnPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Expiry of grant funding
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Glyceryl Tridecanoate | Drug | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Active
- description
- Glyceryl Tridecanoate emulsion, single doses (5 g, 10 g, 20 g) to 3 cohorts
- interventionNames
- Drug: Glyceryl Tridecanoate
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Sunflower oil emulsion, single doses (5 g, 10 g, 20 g) to 3 cohorts
- interventionNames
- Other: Placebo
Primary outcomes (1)
- measure
- Incidence and severity of adverse events/severe events
- timeFrame
- 8 to 10 days
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 21 Years
- Maximum age
- 40 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.