DHA Supplements to Improve Insulin Sensitivity in Obese Pregnant Women (The Omega-3 Pregnancy Study)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00865683|
Recruitment Status : Unknown
Verified July 2009 by National Heart, Lung, and Blood Institute (NHLBI).
Recruitment status was: Recruiting
First Posted : March 19, 2009
Last Update Posted : July 15, 2009
|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|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||DHA, Inflammation, and Insulin Sensitivity|
|Study Start Date :||April 2009|
|Estimated Primary Completion Date :||July 2011|
|Estimated Study Completion Date :||July 2011|
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).
- Insulin sensitivity [ Time Frame: Measured at approximately Month 3 ]
- Interleukin-6 (IL-6) [ Time Frame: Measured at approximately Month 3 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00865683
|Contact: Debra A. Krummel, PhD, RDfirstname.lastname@example.org|
|Contact: Margaret Andrews, MD, MS, RDemail@example.com|
|United States, Ohio|
|General Clinical Research Center||Recruiting|
|Cincinnati, Ohio, United States, 45229-3039|
|Contact: Margaret Andrews, MD, MS, RD 513-558-7042 firstname.lastname@example.org|
|Contact: Anu Gundamaraju, BS 513-558-7041 email@example.com|
|Principal Investigator: Debra A. Krummel, PhD, RD|
|Principal Investigator:||Debra A. Krummel, PhD, RD||University of Cincinnati|