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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Heart, Lung, and Blood Institute (NHLBI).
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Mead Johnson Nutrition
DSM Nutritional Products, Inc.
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00865683
First received: March 17, 2009
Last updated: July 14, 2009
Last verified: July 2009

March 17, 2009
July 14, 2009
April 2009
July 2011   (final data collection date for primary outcome measure)
Insulin sensitivity [ Time Frame: Measured at approximately Month 3 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00865683 on ClinicalTrials.gov Archive Site
Interleukin-6 (IL-6) [ Time Frame: Measured at approximately Month 3 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
DHA Supplements to Improve Insulin Sensitivity in Obese Pregnant Women (The Omega-3 Pregnancy Study)
DHA, Inflammation, and Insulin Sensitivity

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.

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.

Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Overweight and Obesity
  • Insulin Resistance
  • Diabetes, Gestational
  • Hypertension in Pregnancy
  • Pre-Eclampsia
  • 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).
  • Active Comparator: 1
    Participants will receive DHA supplements.
    Intervention: Dietary Supplement: DHA Supplements
  • Placebo Comparator: 2
    Participants will receive placebo capsules of corn oil.
    Intervention: Dietary Supplement: Placebo Supplements
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
90
July 2011
July 2011   (final data collection date for primary outcome measure)

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
Female
18 Years to 40 Years
Yes
Contact: Debra A. Krummel, PhD, RD 513-558-8537 debra.krummel@uc.edu
Contact: Margaret Andrews, MD, MS, RD 513-558-7042 margaret.andrews@uc.edu
United States
 
NCT00865683
618, HL093532-01
No
Debra A. Krummel, PhD, RD, University of Cincinnati
National Heart, Lung, and Blood Institute (NHLBI)
  • Office of Research on Women's Health (ORWH)
  • Mead Johnson Nutrition
  • DSM Nutritional Products, Inc.
Principal Investigator: Debra A. Krummel, PhD, RD University of Cincinnati
National Heart, Lung, and Blood Institute (NHLBI)
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP