Polycystic Ovary SyndromePhase 1NCT03255889
Absorption and Tolerability Studies of an Emulsion Containing the Coconut Oil-derived Glycerol Tridecanoate in Healthy Men
A Phase 1 study testing Glyceryl Tridecanoate in people with Polycystic Ovary Syndrome, run by National University Hospital, Singapore at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Glyceryl Tridecanoate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteSingapore
- Study dates
- 28 Aug 2017to 28 Mar 2018
- Phase
- Phase 1
- 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 21 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Singapore1 site
Investigational Medicine Unit, National University Health System
Singapore, 117599
About this study
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.
Read the 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.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Glyceryl Tridecanoate, Placebo
- Keywords
- Safety, Tolerability, Pharmacokinetics, Absorption
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glyceryl TridecanoateDrug
Also called GT
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%).
PlaceboOther
Sunflower oil emulsion of equal calories.
| Study group | Role | What they receive |
|---|---|---|
| Active | Active comparator | Glyceryl Tridecanoate emulsion, single doses (5 g, 10 g, 20 g) to 3 cohorts Receives: Drug: Glyceryl Tridecanoate |
| Placebo | Placebo comparator | Sunflower oil emulsion, single doses (5 g, 10 g, 20 g) to 3 cohorts Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events/severe events
Incidence and severity of adverse events/serious adverse events based on history, physical examination and vital signs and clinical chemistry
Measured: 8 to 10 days
Secondary outcomes (1)
Decanoic acid
Serum will be extracted from blood samples for measurement of decanoic acid using gas chromatography-mass spectrometry (GC/MS)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2017
- Study start28 Aug 2017 (estimated)
- Primary completion24 Sep 2017 (estimated)
- Study completion28 Mar 2018 (estimated)
Why it stopped: Expiry of grant funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Obstetrics & Gynaecology, National University Hospital, Singapore
- Investigators
- Eu Leong Yong, MD & PhD, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03255889
- Sponsor's protocol ID
- GT2016
- Status last verified
- Dec 2017
- First submitted
- 13 Aug 2017
- Last updated
- 7 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Absorption and Tolerability Studies of an Emulsion Containing the Coconut Oil-derived Glycerol Tridecanoate in Healthy Men
- ClinicalTrials.gov ID
- NCT03255889
- Acronym / sponsor ID
- GT2016
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- Safety, Tolerability, Pharmacokinetics, Absorption
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Expiry of grant funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- 28 Aug 2017 (estimated)
- Primary completion
- 24 Sep 2017 (estimated)
- Study completion
- 28 Mar 2018 (estimated)
- First posted
- 21 Aug 2017 (actual)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Active comparator | Drug: Glyceryl TridecanoateGlyceryl Tridecanoate emulsion, single doses (5 g, 10 g, 20 g) to 3 cohorts |
| Placebo | Placebo comparator | Other: PlaceboSunflower oil emulsion, single doses (5 g, 10 g, 20 g) to 3 cohorts |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
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 |
|---|---|---|
| Glyceryl TridecanoateAlso: GTGlyceryl 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%). | Drug | Active |
| PlaceboSunflower oil emulsion of equal calories. | Other | Placebo |
Primary outcome
Incidence and severity of adverse events/severe events
Time frame: 8 to 10 days
Incidence and severity of adverse events/serious adverse events based on history, physical examination and vital signs and clinical chemistry
1 secondary outcome
Decanoic acid
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2017.
- Individual participant dataSharing planned: No
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The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
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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.
Eu Leong Yong, MD & PhD principal investigator
National University Hospital, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Glyceryl Tridecanoate in people with Polycystic Ovary Syndrome, run by National University Hospital, Singapore at 1 site in Singapore.
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 7 inclusion and 7 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: withdrawn, as of the sponsor's last update on 7 Dec 2017. 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 Singapore. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Incidence and severity of adverse events/severe events (time frame: 8 to 10 days). 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 7 Dec 2017.