A Phase 1 interventional study of OM3-supplement 1 and OM3-supplement 2 in Overweight and Obesity, sponsored by Société des Produits Nestlé (SPN). Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-05-16.
Sponsored by Société des Produits Nestlé (SPN) (part of Nestlé S.A.) · Phase 1, Interventional, and Other
This protocol will determine the pK profile of two different omega-3 fatty acid supplements on plasma EPA and DHA levels.
This protocol is to assess the omega-3 blood levels of DHA and EPA following a single dose administration of study products by means of pharmacokinetics over a 24 hour period of time (post-dose).
3,767 studies on the registry are indexed under Overweight; 863 are open to participants now.
This study's enrollment of 30 is below the median of 73 across 3,263 interventional studies indexed under Overweight.
Browse Overweight studies →Société des Produits Nestlé (SPN) is the lead sponsor of 324 studies on the registry; 16 are open to participants now.
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Exclusion Criteria:
Having the following medical conditions:
i. Malabsorptive disorders including but not limited to pancreatitis, Crohn's disease, etc.
ii. Hypertriglyceridemia (as defined by the Inclusion and per PI discretion; Total cholesterol > 240 mg/dl; LDL > 160 mg/dl; TG > 199 mg/dl) iii. Type2 Diabetes Mellitus
1 g capsule for OM3-supplement 1 given once
Dietary Supplement: OM3-supplement 1
1 g capsule for OM3-supplement 2 given once
Dietary Supplement: OM3-supplement 2
1g of OM3-supplement 1 will be given to subjects to look at DHA/EPA blood absorption
1g of OM3-supplement 2 will be given to subjects to look at DHA/EPA blood absorption
AUC0-t
The plasma pharmacokinetics (AUC0-t) resulting from a single oral dose administration will be estimated from 0 to 24 hours post-dose
Time frame: from 0 to 24 hours
AUC0-inf
The plasma pharmacokinetics (AUC0-t) resulting from a single oral dose administration will be estimated from o to infinity
Time frame: from 0 to infinity
Cmax
The plasma pharmacokinetics (Cmax) resulting from a single oral dose administration will be estimated from 0 to 24 hours post-dose
Time frame: between 0 and 24 hours
tmax
The plasma pharmacokinetics (tmax) resulting from a single oral dose administration will be estimated from 0 to 24 hours post-dose
Time frame: between 0 and 24 hours
t½
The plasma pharmacokinetics (t1/2) resulting from a single oral dose administration will be estimated from 0 to 24 hours post-dose
Time frame: between 0 and 24 hours
Plan to share: No
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This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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Société des Produits Nestlé (SPN) →