Overweight and ObesityPhase 1NCT00865683
DHA Supplements to Improve Insulin Sensitivity in Obese Pregnant Women (The Omega-3 Pregnancy Study)
A Phase 1 study testing DHA Supplements in people with Overweight and Obesity and Insulin Resistance, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity, Insulin Resistance, Diabetes, Gestational
- What is being tested?
- DHA Supplements
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Jul 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pre-pregnant body mass index greater than 25
- Singleton pregnancy
- Speaks English
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
General Clinical Research Center
Cincinnati, Ohio, 45229-3039
Margaret Andrews, MD, MS, RD, 513-558-7042, margaret.andrews@uc.edu
Anu Gundamaraju, BS, 513-558-7041, gundamaa@email.uc.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Overweight and Obesity, Insulin Resistance, Diabetes, Gestational, Hypertension in Pregnancy, Pre-Eclampsia
- Being tested
- DHA Supplements, Placebo Supplements
- Keywords
- Gestational Diabetes, Pregnancy, Docosahexaenoic Acid, DHA, Maternal-Fetal Exchange
- Medical subject headings
- Overweight, Obesity, Insulin Resistance, Diabetes, Gestational, Hypertension, Pregnancy-Induced, Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DHA SupplementsDietary supplement
Participants will receive 800 mg of DHA each day for approximately 3 months (until they give birth).
Placebo SupplementsDietary supplement
Participants will receive placebo supplements each day for approximately 3 months (until they give birth).
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Participants will receive DHA supplements. Receives: Dietary Supplement: DHA Supplements |
| 2 | Placebo comparator | Participants will receive placebo capsules of corn oil. Receives: Dietary Supplement: Placebo Supplements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity
Measured: Measured at approximately Month 3
Secondary outcomes (1)
Interleukin-6 (IL-6)
Measured: Measured at approximately Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2009 (estimated)
- Study startApr 2009
- Primary completionJul 2011 (estimated)
- Study completionJul 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Office of Research on Women's Health (ORWH), Mead Johnson Nutrition, dsm-firmenich Switzerland AG
- Investigators
- Debra A. Krummel, PhD, RD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00865683
- Sponsor's protocol ID
- 618
- Other IDs
- HL093532-01
- Status last verified
- Jul 2009
- First submitted
- 17 Mar 2009
- Last updated
- 15 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29053802
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DHA, Inflammation, and Insulin Sensitivity
- ClinicalTrials.gov ID
- NCT00865683
- Acronym / sponsor ID
- 618
- Conditions
- Overweight and Obesity, Insulin Resistance, Diabetes, Gestational, Hypertension in Pregnancy, Pre-Eclampsia
- Keywords
- Gestational Diabetes, Pregnancy, Docosahexaenoic Acid, DHA, Maternal-Fetal Exchange
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Collaborators
- Office of Research on Women's Health (ORWH), Mead Johnson Nutrition, dsm-firmenich Switzerland AG
- Study start
- Apr 2009
- Primary completion
- Jul 2011 (estimated)
- Study completion
- Jul 2011 (estimated)
- First posted
- 19 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Dietary Supplement: DHA SupplementsParticipants will receive DHA supplements. |
| 2 | Placebo comparator | Dietary Supplement: Placebo SupplementsParticipants will receive placebo capsules of corn oil. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Pre-pregnant body mass index greater than 25
- Singleton pregnancy
- Speaks English
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DHA SupplementsParticipants will receive 800 mg of DHA each day for approximately 3 months (until they give birth). | Dietary supplement | 1 |
| Placebo SupplementsParticipants will receive placebo supplements each day for approximately 3 months (until they give birth). | Dietary supplement | 2 |
Primary outcome
Insulin sensitivity
Time frame: Measured at approximately Month 3
1 secondary outcome
Interleukin-6 (IL-6)
Time frame: Measured at approximately Month 3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2009.
- Derived from this study: PubMed 29053802Lager 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Debra A. Krummel, PhD, RD principal investigator
University of Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DHA Supplements in people with Overweight and Obesity and Insulin Resistance, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Debra A. Krummel, PhD, RD (513-558-8537, debra.krummel@uc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin sensitivity (time frame: Measured at approximately Month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00865683, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2009.