UnknownPhase 1

DHA Supplements to Improve Insulin Sensitivity in Obese Pregnant Women (The Omega-3 Pregnancy Study)

United States90 participantsStarted 2009-04

Plain-language 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.

Who can participate

Age range18 Years – 40 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Pre-pregnant body mass index greater than 25 * Singleton pregnancy * Speaks English Exclusion Criteria: * High intake of DHA foods (i.e., more than 1 fish meal per week, use of DHA-fortified foods, or use of any supplements that contain DHA) * Concurrent inflammatory, vascular, or metabolic disease, including diabetes, polycystic ovary disease, collagen vascular disease, inflammatory bowel disease, or infection * Current or previous use of tobacco, street drugs, or medications known to affect inflammatory markers, including corticosteroids * Excessive weight gain or loss before pregnancy (more than 20 pounds), including weight loss due to bariatric surgery * Plans to leave the area during the study period * Inability to travel to General Clinical Research Center

What they're measuring

Insulin sensitivity

Timeframe: Measured at approximately Month 3

Trial details

NCT IDNCT00865683

SponsorNational Heart, Lung, and Blood Institute (NHLBI)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2011-07

Contact for this trial

Debra A. Krummel, PhD, RD

513-558-8537 debra.krummel@uc.edu