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
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: DHA, Inflammation, and Insulin Sensitivity

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:
  • Insulin sensitivity [ Time Frame: Measured at approximately Month 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Interleukin-6 (IL-6) [ Time Frame: Measured at approximately Month 3 ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: April 2009
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00865683

Contacts
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

Locations
United States, Ohio
General Clinical Research Center Recruiting
Cincinnati, Ohio, United States, 45229-3039
Contact: Margaret Andrews, MD, MS, RD    513-558-7042    margaret.andrews@uc.edu   
Contact: Anu Gundamaraju, BS    513-558-7041    gundamaa@email.uc.edu   
Principal Investigator: Debra A. Krummel, PhD, RD         
Sponsors and Collaborators
Mead Johnson Nutrition
DSM Nutritional Products, Inc.
Investigators
Principal Investigator: Debra A. Krummel, PhD, RD University of Cincinnati
  More Information

No publications provided

Responsible Party: Debra A. Krummel, PhD, RD, University of Cincinnati
ClinicalTrials.gov Identifier: NCT00865683     History of Changes
Other Study ID Numbers: 618, HL093532-01
Study First Received: March 17, 2009
Last Updated: July 14, 2009
Health Authority: United States: Federal Government

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):
Gestational Diabetes
Pregnancy
Docosahexaenoic Acid
DHA
Maternal-Fetal Exchange

Additional relevant MeSH terms:
Hypertension, Pregnancy-Induced
Hypertension
Overweight
Insulin Resistance
Pre-Eclampsia
Diabetes, Gestational
Vascular Diseases
Cardiovascular Diseases
Body Weight
Signs and Symptoms
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Pregnancy Complications
Diabetes Mellitus
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 18, 2014