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

• Status: Withdrawn
• Trial end date: 2018-03-28
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National University Hospital, Singapore

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.