Efficacy and Safety Study of DHA-O in Adults With Hypertriglyceridemia

DSM Nutritional Products

Status: Completed

Conditions: Hypertriglyceridemia

Treatments: Dietary Supplement: Fish oil; Dietary Supplement: DHA-O; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01737099

2012-1048

Details and patient eligibility

About

The purpose of this study is to investigate the efficacy and safety of DHA-O to lower elevated triglyceride levels in healthy adults with hypertriglyceridemia.

Enrollment: 93 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• ages 18-79
• fasting TG levels, 150-499 mg/dL
• baseline DHA intake <200mg/d
• active and in good health

Exclusion criteria

• recent diagnosis of CHD or history of revascularization within 6mos of study
• use of lipid altering medications (other than stable statins)
• use of anticoagulants
• use of omega-3 products within 4 weeks of screening
• serum AST/ALT >1.5x ULN and/or creatinine >1.5 mg/dL at screening
• lipid altering foods or supplements
• women who are pregnant or of childbearing potential not using adequate birth control
• current use or history of drug or alcohol abuse
• inability to swallow capsules

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

93 participants in 3 patient groups, including a placebo group

DHA-O

Experimental group

Treatment:

Dietary Supplement: DHA-O

Fish oil

Active Comparator group

Treatment:

Dietary Supplement: Fish oil

Placebo

Placebo Comparator group

Treatment:

Dietary Supplement: Placebo