DHA Supplements to Improve Insulin Sensitivity in Obese Pregnant Women (The Omega-3 Pregnancy Study)
Primary Purpose
Overweight and Obesity, Insulin Resistance, Diabetes, Gestational
Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
DHA Supplements
Placebo Supplements
Sponsored by
About this trial
This is an interventional treatment trial for Overweight and Obesity focused on measuring Gestational Diabetes, Pregnancy, Docosahexaenoic Acid, DHA, Maternal-Fetal Exchange
Eligibility 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
Sites / Locations
- General Clinical Research CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1
2
Arm Description
Participants will receive DHA supplements.
Participants will receive placebo capsules of corn oil.
Outcomes
Primary Outcome Measures
Insulin sensitivity
Secondary Outcome Measures
Interleukin-6 (IL-6)
Full Information
NCT ID
NCT00865683
First Posted
March 17, 2009
Last Updated
July 14, 2009
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborators
Office of Research on Women's Health (ORWH), Mead Johnson Nutrition, DSM Nutritional Products, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00865683
Brief Title
DHA Supplements to Improve Insulin Sensitivity in Obese Pregnant Women (The Omega-3 Pregnancy Study)
Official Title
DHA, Inflammation, and Insulin Sensitivity
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Unknown status
Study Start Date
April 2009 (undefined)
Primary Completion Date
July 2011 (Anticipated)
Study Completion Date
July 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborators
Office of Research on Women's Health (ORWH), Mead Johnson Nutrition, DSM Nutritional Products, Inc.
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity, Insulin Resistance, Diabetes, Gestational, Hypertension in Pregnancy, Pre-Eclampsia
Keywords
Gestational Diabetes, Pregnancy, Docosahexaenoic Acid, DHA, Maternal-Fetal Exchange
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Participants will receive DHA supplements.
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo capsules of corn oil.
Intervention Type
Dietary Supplement
Intervention Name(s)
DHA Supplements
Intervention Description
Participants will receive 800 mg of DHA each day for approximately 3 months (until they give birth).
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo Supplements
Intervention Description
Participants will receive placebo supplements each day for approximately 3 months (until they give birth).
Primary Outcome Measure Information:
Title
Insulin sensitivity
Time Frame
Measured at approximately Month 3
Secondary Outcome Measure Information:
Title
Interleukin-6 (IL-6)
Time Frame
Measured at approximately Month 3
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Debra A. Krummel, PhD, RD
Phone
513-558-8537
Email
debra.krummel@uc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Margaret Andrews, MD, MS, RD
Phone
513-558-7042
Email
margaret.andrews@uc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Debra A. Krummel, PhD, RD
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
General Clinical Research Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229-3039
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margaret Andrews, MD, MS, RD
Phone
513-558-7042
Email
margaret.andrews@uc.edu
First Name & Middle Initial & Last Name & Degree
Anu Gundamaraju, BS
Phone
513-558-7041
Email
gundamaa@email.uc.edu
First Name & Middle Initial & Last Name & Degree
Debra A. Krummel, PhD, RD
12. IPD Sharing Statement
Citations:
PubMed Identifier
29053802
Citation
Lager S, Ramirez VI, Acosta O, Meireles C, Miller E, Gaccioli F, Rosario FJ, Gelfond JAL, Hakala K, Weintraub ST, Krummel DA, Powell TL. Docosahexaenoic Acid Supplementation in Pregnancy Modulates Placental Cellular Signaling and Nutrient Transport Capacity in Obese Women. J Clin Endocrinol Metab. 2017 Dec 1;102(12):4557-4567. doi: 10.1210/jc.2017-01384.
Results Reference
derived
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DHA Supplements to Improve Insulin Sensitivity in Obese Pregnant Women (The Omega-3 Pregnancy Study)
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