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

NCT02140879 | Withdrawn

• 1 other identifier: PBRC 11031
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy; Inflammation

Keywords

pregnancy; inflammation; infant assessment

Outcome Measures

Primary Outcomes (1)

• Differences in maternal inflammation between the two study groups.

  Pregnancy creates a state of insulin resistance that is worsened by excess weight during pregnancy and it is accompanied by inflammation. Inflammation in pregnant women will be measured by a blood draw from the arm and analysis of the blood.

  The Participant will be followed during pregnancy, between the 17th and 36th week of pregnancy, on average of 19 weeks.

Secondary Outcomes (1)

• Differences in infant growth will be determined with measurements of infant height and weight and with an instrument that determines air displaced by the baby's body.

  The participant will be followed the First year of life, an expected average of 52 weeks.

Study Arms (2)

Capsule 1

PLACEBO COMPARATOR

Placebo is a mixture of corn and soy oils.

Dietary Supplement: Capsule 1 or Capsule 2; Dietary Supplement: Capsule 2

Capsule 2

ACTIVE COMPARATOR

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

Dietary Supplement: Capsule 1 or Capsule 2; Dietary Supplement: Capsule 2

Interventions

Capsule 1 or Capsule 2 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 1; Capsule 2

Capsule 2 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 1; Capsule 2

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead
• United States Department of Agriculture (USDA): collaborator

Study Sites (1)

Womans Hospital

Baton Rouge, Louisiana, 70803, United States

Location

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Carol J Lammi-Keefe, PhD, RD

  PBRC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2014
• First Posted: May 16, 2014
• Study Start: April 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: August 1, 2017
• Last Updated: September 15, 2022

Record last verified: 2022-09

Locations

US (1)