None listed
Conditions
Brief summary
This study will be an open-label, 12 week, clinical trial in males aged 18 to 45 with the aim: To compare genetic expression patterns after 12 weeks treatment of temulawak extract in male adults. To evaluate safety parameters of the active compound. A total of 32 participants will be enrolled into the study in order to allow for 24 participants to complete the study. Participants will be asked to attend the clinic at Screening, Day 1 (Visit 1), Day 7 (Visit 2), Day 40 (visit 3) and Day 81 (visit 4) the end of study visit. The study will last approximately 4 months in total for each participant from screening to last visit. Participants will need to attend the clinical unit 5 times for around three hours at each visit.
Interventions
5x 1000mg Temulawak oral tablets standardised to 750mg curcuminoids once daily for 16 weeks.
Adherence will be assessed at each visit by return of containers and review of a memory aid. Subjects will also receive a weekly follow-up phone call to check compliance with taking study medication
Sponsors
SFI Research Pty Ltd.
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy as determined by a responsible physician, based on a medical evaluation including medical history, physical examination, clinical laboratory test results and ECG. Subjects who have abnormal safety laboratory test results outside of the local laboratory normal reference will be excluded from the study at the PIs discretion. One repeat test will be allowed for all out of range results. 2. Males 18-45 years of age 3. BMI between 25-35 4. Non-smoker/Light Smoker (less than 5 cigarettes per day). 5. Agree to abstain from alcohol 24 hours prior to each study visit. 6. Agree to all visits and procedures for the duration of the study 7. Agree to not include any turmeric in their diet for the 12 weeks study duration 8. Agree to avoid consuming spicy foods in their diet for a 3 day period before each visit 9. Agree not to take any dietary supplements, herbal medicines (including, but not limited to, Protein powder blends, St John’s Wort, Turmeric, Curcumin, Silymarin) vitamins, mineral, prescription and/or non-prescription drugs or medicines (including anti-inflammatory drugs) for the duration of the study. Exceptions are allowed for paracetamol as long it is noted in as a concomitant medication. Pure protein powder (e.g. 100% whey) supplements are allowed 10. Provide Informed Consent 11. Agree to use adequate birth control (barrier method of birth control or abstinence) prior to study entry and during the trial and agrees not to donate sperm, for the duration of the study
Exclusion criteria
1. History or current diagnosis of substance abuse that would, in the opinion of the investigator, affect the subject’s ability to comply with the study requirements 2. History or current diagnosis of a significant psychiatric disorder that would, in the opinion of the investigator, affect the subject’s ability to comply with the study requirements 3. Signs and symptoms of chronic and/or acute inflammation and/or infection 4. Positive result for the presence of Hepatitis B surface antigen (HBsAg), Hepatitis C virus antibodies (HCV-Ab), or human immunodeficiency virus (HIV) antibodies. 5. A positive drug/alcohol screen 6. Has a history of alcohol and/or drug abuse < 12 months from Screening 7. History of current diagnosis of any bleeding disorders 8. Consumption of more than three units of alcohol in any 24 hour period for the duration of the trial (1 Unit = 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol) 9. Participation in a clinical trial or has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer). 10. BMI > 35 11. BMI < 25 12. Current use (within the past 4 weeks) of dietary supplements, protein powder blends, herbal medicines (including St John’s Wort, Turmeric, Curcumin, Silymarin) vitamins, minerals, prescription and/or non-prescription drugs or medicines (including anti-inflammatory drugs). Otherwise potentially eligible participants, who are not consuming curcumin products, and are willing to stop current use, can be re-screened for eligibility after a 2 week washout period. 13. Use of anti-inflammatory medications (>2 weeks, within the past 12 weeks) 14. Subject has donated blood or plasma or clinically significant blood loss within 60 days to the screening visit 15. History of migraine. 16. Unwillingness or inability to follow the procedures outlined in the protocol. 17. Vegetarian, vegan, or other significant dietary restriction and who do not agree to consume any of the standardized food. 18. Subjects with known hypersensitivity to the active substance or any of the excipients 19. Any other condition is present that in the opinion of the investigator might jeopardize the patient's safety or ability to comply with requirements of the study.
Outcome results
None listed