None listed
Conditions
Interventions
Intervention1: Omega 3 powder: Oral Dose
Self emulsifying omega 3 powder dissolved in 240 ml orange juice
1 times
Control Intervention1: Omega 3 oil: Oral Dose
700 mg EPA per gram
1 time
Sponsors
Dr Itay Shafat
Eligibility
Inclusion criteria
Inclusion criteria: Subject is male or female where any of the gender is not less than 25% of sample size Subject with 30-55 years of age both inclusive Subject has a body mass index 18.50-29.99 kg m2 Subject is judged by the investigator to be in generally good health based on medical history physical examination vital signs and routine laboratory testing Subject is willing and able to undergo the scheduled study procedures Subject is willing to avoid excluded medications/supplements for the duration of the study Subject is willing to abstain from consuming fish seafood omega-3 supplements or other dietary supplements or ALA-rich food Subject is willing to abstain from consuming caffeine and other methyl xanthine containing products such as coffee black or green tea cocoa rich food and energy drinks within 18 h prior to test visits
Exclusion criteria
Exclusion criteria: Individual has fasting laboratory test results of clinical significance Individual has TG greater than or equal to 150 mg/dL and/or LDL-C greater than or equal to 160 mg/dL and/or non-HDL-C greater than or equal to 100 mg/dL at screening Individual has positive urine drug screen results Individual has any condition that might impair fat absorption Individual has uncontrolled hypertension Individual has a history of cancer in the prior 5 years, except non-melanoma skin cancer or carcinoma in situ of the cervix Individual has made a blood donation in excess of 500 mL or had excess blood loss within 3 months of day 0 Individual uses cyclic or any other discontinuous hormone replacement therapy Individual smokes or has used any nicotine product in the last 6 months Individual has consumed fish, seafood, omega-3 supplements, or ALA-rich food within 20 days before randomization, during the test visit periods, and during the washout between test visits
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome variable will be the comparison of net incremental area under the curve from 1 to 24 h (niAUC) for EPA following a single oral dose of a self-emulsifying omega-3 powder dissolved in 240 ml juice (Orange) as against net incremental area under the curve from 1 to 24 h (niAUC) for EPA following 1.7 ml of omega-3 oil taken with 240 ml of juice (Orange)Timepoint: Day 0, Day 1, Day 27, Day 28, Day 29 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study outcome variables will include differences between a self-emulsifying powdered omega-3 product dissolved in 240 ml juice compared to a chemically identical, commercially available oily omega-3 dietary supplementTimepoint: Day 0, Day 1, Day 27, Day 28, Day 29 | — |
Countries
India
Contacts
Public ContactDr Annamalai K MBBS MBA MSc
Spinos Lifescience and Research Pvt Ltd
Outcome results
None listed