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

Sponsor

National Heart, Lung, and Blood Institute (NHLBI) (NIH)

Overall Status

Unknown status

CT.gov ID

NCT00865683

Collaborator

Office of Research on Women's Health (ORWH) (NIH), Mead Johnson Nutrition (Industry), DSM Nutritional Products, Inc. (Industry)

Enrollment

Location

Arms

Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Overweight and Obesity Insulin Resistance Diabetes, Gestational Hypertension in Pregnancy Pre-Eclampsia	Dietary Supplement: DHA Supplements Dietary Supplement: Placebo Supplements	Phase 1

Detailed Description

The effects of overweight and obesity during pregnancy on maternal and child health can be serious and long lasting. Overweight and obese women are more likely to develop gestational diabetes or pre-eclampsia (high blood pressure and proteinuria) during pregnancy and type 2 diabetes and cardiovascular disease after pregnancy. Also, children born to these women have an increased risk of obesity, diabetes, and high blood pressure later in life. The increased risk of these diseases and conditions may occur because overweight and obese pregnant women have decreased insulin sensitivity and increased inflammation. The nutrient DHA is an omega-3 fatty acid that is important for brain function, the development of the central nervous system, and visual function in infants. DHA may also benefit both pregnant women and their babies by improving insulin sensitivity and decreasing inflammation, thereby decreasing the risk of gestational diabetes and pre-eclampsia during pregnancy. The purpose of this study is to evaluate the effect of DHA supplementation on insulin sensitivity, inflammation, and fetal growth in overweight and obese pregnant women.

This study will enroll women at 24 to 28 weeks of pregnancy. They will be followed until delivery. Participants will be randomly assigned to receive either DHA supplements or placebo on a daily basis until the end of their pregnancies. At a baseline study visit, a blood sample will be collected; height, weight, and skinfold thickness will be measured; and questionnaires to assess diet and medical history will be given. Participants will complete three diet recalls in the days after the visit, in which they will answer questions about their diet in the previous 24 hours. At a second study visit that will occur at 30 to 32 weeks of pregnancy, a blood sample will be collected. At a third study visit that will occur at 34 to 36 weeks of pregnancy, a blood sample will be collected and repeat body measurements will occur. Three diet recalls will then be completed, and participants will take part in a meal challenge, in which blood will be collected at different times after eating a study-provided breakfast. Researchers will review participants' medical records after the birth occurs.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

DHA, Inflammation, and Insulin Sensitivity

Study Start Date :

Apr 1, 2009

Anticipated Primary Completion Date :

Jul 1, 2011

Anticipated Study Completion Date :

Jul 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 Participants will receive DHA supplements.	Dietary Supplement: DHA Supplements Participants will receive 800 mg of DHA each day for approximately 3 months (until they give birth).
Placebo Comparator: 2 Participants will receive placebo capsules of corn oil.	Dietary Supplement: Placebo Supplements Participants will receive placebo supplements each day for approximately 3 months (until they give birth).

Arm

Intervention/Treatment

Active Comparator: 1

Participants will receive DHA supplements.

Dietary Supplement: DHA Supplements

Participants will receive 800 mg of DHA each day for approximately 3 months (until they give birth).

Placebo Comparator: 2

Participants will receive placebo capsules of corn oil.

Dietary Supplement: Placebo Supplements

Participants will receive placebo supplements each day for approximately 3 months (until they give birth).

Outcome Measures

Primary Outcome Measures

Insulin sensitivity [Measured at approximately Month 3]

Secondary Outcome Measures

Interleukin-6 (IL-6) [Measured at approximately Month 3]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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