LA Moms and Babies Study (LAMBS) for Nutrition and Growth

NCT ID: NCT02140879

Last Updated: 2022-09-15

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2017-08-31

Brief Summary

This research study will examine how diet during pregnancy can benefit pregnancy and pregnancy outcome, such as your baby's weight. More specifically, the investigators will study the effects of two different food oils/fats that are commonly consumed to determine if one is more effective in limiting maternal inflammation during pregnancy. You are being asked to take part in this study because it will help us update and make the best dietary recommendations for pregnant women and women of child bearing ages.

Detailed Description

Pregnant women will be asked to consume dietary supplements (2 capsules, from the Pennington Biomedical Pharmacy) each day during pregnancy. They will begin taking the capsules around 17 weeks of pregnancy and take them each day until their babies are born. Women will be randomized to one of two groups. Randomization means they will be put into a group by chance, similar to flipping a coin. One group, the placebo group of the study, will take capsules containing oil '1 ' which is a mixture of corn and soy oils . The other group, the supplement group, will take capsules containing oil '2' which is an algal oil. Both oils are found in our diets. Neither the subject nor the study staff will know which group women are in.

Women will also keep a diary of how many capsules they take. At around 17, 22, 24, 26, 30, 32, and 36 weeks of pregnancy, women will go to Woman's Hospital to get new capsules and return any remaining capsules and their capsule diary. If they are not able to go to Woman's Hospital at weeks 22, 26, or 32 a researcher will arrange to meet them at an agreed upon prearranged place, such as a pharmacy, a library, or Pennington Biomedical, for example. At the same visits to Woman's Hospital at weeks 17, 24, 30, and 36 weeks of pregnancy women will also have their blood drawn (approximately one tablespoon).

At 17, 22, 24, 26, 30, 32 and 36 weeks of pregnancy we will also ask women about the foods they are eating. We will do this by a prearranged phone call; women will not need to meet us in person for this.

Researchers will contact subjects weekly by phone to inquire about compliance with consumption of capsules. Contact will only take place during weeks in which a visit or phone call regarding diet is not required.

At 17, 24, 30, and 36 weeks of pregnancy small blood samples will be collected from their arm (approximately one tablespoon at each collection) for laboratory analyses. At the birth of their baby a sample of blood will be collected from the umbilical cord after their baby is delivered. All blood samples will be stored at Pennington Biomedical. Blood samples will be analyzed by the researchers who are involved in the study. Some analyses will take place at Pennington Biomedical and Louisiana State University (LSU). Deidentified (without subject names) samples will be sent to study researchers at Northeastern University in Boston, LSU Health Sciences Center in New Orleans, and DSM Nutritional Products in Columbia, Maryland for some of the analyses. At the end of the study remaining blood samples will be discarded unless women consent for their blood to be used for future research. Should women decide to withdraw from the study, any samples collected thus far will be included in the study since they will be deidentified and the investigators will not know which samples belong to each person. We will also collect information about the baby's birth weight, length, and health from the baby's hospital chart.

When the baby is 2 weeks, 6 months, and 12 months of age we will measure the baby's body fat and lean tissue. To do this measurement the baby will lie or sit in an enclosed chamber where the mother can see her baby during the measurements. There are no attachments made to the baby. At these times we will also determine the baby's body fat by measuring the thickness of the baby's skinfold; this is done by gently lifting a double fold of skin on the baby's hip, upper arm (triceps), and back of the thigh and measuring the thickness of that fold with a handheld instrument with two hinged arms that fit over the skinfold. There is no discomfort associated with this procedure. The measurements will be made at Woman's Hospital. During these visits we will also ask questions about how the mother is feeding her baby. Between these visits (when the baby is 2, 4, 8, and 10 months old) we will phone to ask about how the baby is being fed and to inquire about the mother's and baby's well-being.

Conditions

Pregnancy; Inflammation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Capsule 1

Placebo is a mixture of corn and soy oils.

Group Type: PLACEBO_COMPARATOR

Capsule 1 or Capsule 2

Intervention Type: DIETARY_SUPPLEMENT

Capsules will be consumed on a daily basis during pregnancy. One group, the placebo group of the study, will take capsules (2/day) containing oil '1 ' which is a mixture of corn and soy oils . The other group, the supplement group, will take capsules containing oil '2' which is an algal oil. Both oils are found in our diets.

Capsule 2

Intervention Type: DIETARY_SUPPLEMENT

Two capsules will be consumed on a daily basis during pregnancy. The other group, the supplement group, will take capsules containing oil '2' which is an algal oil. Both oils are found in our diets. One group, the placebo group of the study, will take capsules containing oil '1 ' which is a mixture of corn and soy oils .

Capsule 2

Active supplement group, will take capsules containing oil '2' which is an algal oil.

Group Type: ACTIVE_COMPARATOR

Capsule 1 or Capsule 2

Intervention Type: DIETARY_SUPPLEMENT

Capsules will be consumed on a daily basis during pregnancy. One group, the placebo group of the study, will take capsules (2/day) containing oil '1 ' which is a mixture of corn and soy oils . The other group, the supplement group, will take capsules containing oil '2' which is an algal oil. Both oils are found in our diets.

Capsule 2

Intervention Type: DIETARY_SUPPLEMENT

Two capsules will be consumed on a daily basis during pregnancy. The other group, the supplement group, will take capsules containing oil '2' which is an algal oil. Both oils are found in our diets. One group, the placebo group of the study, will take capsules containing oil '1 ' which is a mixture of corn and soy oils .

Interventions

Capsule 1 or Capsule 2

Capsules will be consumed on a daily basis during pregnancy. One group, the placebo group of the study, will take capsules (2/day) containing oil '1 ' which is a mixture of corn and soy oils . The other group, the supplement group, will take capsules containing oil '2' which is an algal oil. Both oils are found in our diets.

Intervention Type: DIETARY_SUPPLEMENT

Capsule 2

Two capsules will be consumed on a daily basis during pregnancy. The other group, the supplement group, will take capsules containing oil '2' which is an algal oil. Both oils are found in our diets. One group, the placebo group of the study, will take capsules containing oil '1 ' which is a mixture of corn and soy oils .

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Confirmed pregnancy
• Caucasian/White and African-American ethnicities
• Between the ages of 18 and 35 years
• Overweight before becoming pregnant (BMI=25.0-29.9 kg/m2)
• Pass on the glucose tolerance test for diabetes

Exclusion Criteria

• Have more than 5 children
• Have a history of high blood pressure, high blood lipids, kidney or liver disease
• Have inability to handle blood sugar normally
• Have polycystic ovary syndrome
• Have thyroid disorder
• Have multiple fetuses, pregnancy related complications (preterm labor; diagnosed with gestational diabetes mellitus, pregnancy impaired glucose tolerance, preeclampsia, a first degree relative with diabetes, gave birth to a previous large for gestational age infanthigh blood pressure, premature rupture of the membranes)
• Have smoked in the past 6 months
• Have been pregnant or lactating (breastfeeding) in the past year
• Do not want their baby's body fat measured throughout the first year of life
• Do not bring their prenatal record and study information copies to Woman's Hospital for delivery
• Deliver at a hospital other than Woman's Hospital
• Test positive for human immunodeficiency Virus (HIV), syphilis, sepsis, group B streptococcus, Hepatitis B
• Do not follow study procedures
• Planning to bank cord blood or unwilling to donate cord blood
• Planned/elective C-section.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

United States Department of Agriculture (USDA)

FED

Sponsor Role: collaborator

Pennington Biomedical Research Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carol J Lammi-Keefe, PhD, RD

Role: PRINCIPAL_INVESTIGATOR

PBRC

Locations

Womans Hospital

Baton Rouge, Louisiana, United States

Countries

United States

Other Identifiers

PBRC 11031

Identifier Type: -

Identifier Source: org_study_id