DHA Supplements to Improve Insulin Sensitivity in Obese Pregnant Women (The Omega-3 Pregnancy Study)
NCT00865683 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 90
Last updated 2009-07-15
Summary
Women with excess adiposity while pregnant are more likely to develop gestational diabetes and high blood pressure during pregnancy than women of healthy weights. This may occur because overweight and obese pregnant women are less sensitive to insulin and have more inflammation than pregnant women of healthy weights. This study will examine the effect of a nutritional supplement, docosahexaenoic acid (DHA), on improving insulin sensitivity and lessening inflammation in overweight and obese pregnant women.
Conditions
- Overweight and Obesity
- Insulin Resistance
- Diabetes, Gestational
- Hypertension in Pregnancy
- Pre-Eclampsia
Interventions
- DIETARY_SUPPLEMENT
-
DHA Supplements
Participants will receive 800 mg of DHA each day for approximately 3 months (until they give birth).
- DIETARY_SUPPLEMENT
-
Placebo Supplements
Participants will receive placebo supplements each day for approximately 3 months (until they give birth).
Sponsors & Collaborators
-
Office of Research on Women's Health (ORWH)
collaborator NIH -
Mead Johnson Nutrition
collaborator INDUSTRY -
DSM Nutritional Products, Inc.
collaborator INDUSTRY -
National Heart, Lung, and Blood Institute (NHLBI)
lead NIH
Principal Investigators
-
Debra A. Krummel, PhD, RD · University of Cincinnati
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 40 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2009-04-30
- Primary Completion
- 2011-07-31
- Completion
- 2011-07-31
Countries
- United States
Study Locations
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