Our Research

Actively Enrolling Research

Research Studies Closed to Enrollment


 

Actively Enrolling Research


"CONNECT"

The Effect of Myelin-Relevant Nutrients in Infant Formula on Brain Myelination and Cognitive Development

Breast milk, the recommended choice for infant nutrition, provides key nutrients, which support cognitive benefits. The goal of the CONNECT research study is to explore how early life nutrition and specific nutrients impact brain and cognitive development in the first 2 years of a baby's life.

 

Certain nutrients like folate, iron, DHA and vitamin B12 play a role in myelin development in the brain.Myelin is the protective covering around the nerve fibers, which help brain cells to communicate. Researchers want to explore how specific nutrients important for myelin development, impact brain and cognitive development. If you participate in the study, you will be asked to provide your infant with 1 of 2 infant formulas containing different levels of specific nutrients until your infant reaches 1 year old. Both infant formulas meet Codex nutritional requirements for infants. Participation in this research study will last approximately 2 years.
                                                                                                                                                            https://labs.pbrc.edu/womenshealth/


 

"SmartMoms in WIC"

A smartphone intervention for WIC mothers to improve nutrition and weight gain during preganacy

Weight gain during pregnancy is inevitable and vital for the development of a growing baby. But, excess gestational weight gain has been shown to have long term consequences for both mother and baby. Approximately only 1 in 3 women have healthy weight gain during their pregnancy and women who are overweight or obese before pregnancy have the highest likelihood of gaining excess weight during pregnancy. Economically disadvantaged mothers are vulnerable to poor energy-dense nutrition, sedentary behaviors, excess gestational weight gain, and poor birth outcomes.

 

The objective of SmartMoms in WIC is to promote healthy gestational weight gain during pregnancy using a mobile phone-based weight management program for mothers enrolled in the USDA Special Supplemental Nutrition Program for Women, Infants, and Children (WIC). We will test this mobile phone-based weight management program by enrolling 432 mothers early in pregnancy in WIC clinics across the 9 regions in Louisiana.

 

Participants will either be enrolled to either:

  • Healthy Beginnings program

    • Receive a scale and other technology as well as health information to help manage weight during pregnancy. The program targets healthy gestational weight gain through self-monitoring of weight and activity data combined with automated and personalized feedback from a weight management counselor through a Smartphone or computer. The health information will also be presented through a closed Facebook group, and participants will be encouraged to interact with other participants in the program.

  • WIC Nutrition program

    • Receive care through the standard WIC program and receive weekly health information related to pregnancy, birth, and infant health through a closed Facebook group, and participants will be encouraged to interact with other participants in the program.


"BabyEE" Pilot

Measurement of Energy Metabolism in Infants

Metabolism is a major component of health especially infant health. Scientists are not sure how metabolism is inherited or what factors after birth may influence metabolism, so researchers at Pennington Biomedical are working to better understand the factors that impact metabolism development in infants. The BabyEE Pilot research study will observe and collect information about metabolism, body composition, physical activity, food intake, and feeding behavior of infants during the first three months of life. See our cutting-edge facility below.

 

Visit the Pennington Biomedical website (www.pbrc.edu/babyee) for more information. 

Visit clinicaltrials.gov for more information on this study


"Infant 31P" Pilot

Measurement of Energy Generation in Infant Muscle

The Infant 31P PIlot study will help researchers understand your baby's muscle metabolism. The objective of this study is to devleop a technique for measureing the ability of your baby's muscle to create energy. We will enroll up to 8 infants in the observational method development study which includes a body composition measurement and a MRI measurement of your baby's muscle.

 

Visit the Pennington Biomedical website (www.pbrc.edu/infant31p) for more information

Visit clinicaltrials.gov for more information on this study


 

"BabyFat" Pilot

Measurement of Body Fat in Infants

The BabyFat Pilot study will help researchers learn from factors that impact the health of people beginning in early life and continuing throughout their lifespan. The objective of this study is to develop a technique for measureing whole body adiposity (fat mass) and bown adipose tissue in infants. We will enroll up to 10 infants in the observational method devleopment study which includes body composition measurement, MRI measurement of brown adipose tissue, and questionnaires.

 

Visit the Pennington Biomedical website (www.pbrc.edu/babyfat) for more information

Visit clinicaltrials.gov for more information on this study

 


 

Gene Mapping of PCOS”

 

Up to 10% of women of reproductive age are affected by polycystic ovary syndrome (PCOS), an endocrinopathy characterized by excessive androgen production and reproductive dysfunction. PCOS is a highly heritable, common complex disorder. It is a major risk factor for type 2 diabetes in women and the leading cause of anovulatory infertility. This study is part of a larger registry of PCOS women including women of European and Han Chinese ancestry whose genetic data are used to map chromosomal regions that have a high likelihood of containing genes causing PCOS. The current study will contribute to a new registry enrolling up to 600 African American women with up to 300 women being enrolled at Pennington Biomedical Research Center and up to 300 women being enrolled at Northwestern University in Chicago. These findings could identify novel therapeutic targets and genetic variants conferring substantial risk that could be used for PCOS prediction and prevention.

 

Visit the Pennington website for more information or to screen online.

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Research Studies Closed to Enrollment


"Mito Moms"

The Effect of Physical Activity on in Vivo and in Vitro Mitochondrial Capacity in Pregnant Women

Mitochondria serves as the energy producer of the cell, converting food into energy to power everything that we do. A baby's mitochondria are inherited from their mother so researchers at Pennington Biomedical aimed to compare varying levels of physical activity in moms and see if the different levels had an effect on the mother's metabolism and inherently, the baby's mitochondria and metabolism. The Mito Mom's research study observed and collected information about how physical activity during pregnancy may change your muscle metabolism and how this may be transmitted to your baby. 

 

Visit clinicaltrials.gov for more information on this study


 

IMAGINE”

Investigation of mechanisms for transmission of impaired glucose metabolism in infants exposed to diabetes in utero

Imagine knowing how to possibly impact the health of your baby, not only during pregnancy, but throughout his or her life by the choices you make while you are pregnant. The IMAGINE research study followed pregnant mothers and their babies after birth to explore how certain health characteristics may be passed from mom to baby. The research study assessed how a pregnant mother’s metabolism may set the stage for her child’s future health after it is born. Our metabolism is how our bodies convert food into fuel to power everything we do.

Visit clinicaltrials.gov for more information on this study.


 

MomEE”

Determinants of gestational weight gain in obese pregnant women

In the U.S. the number of obese women entering pregnancy has more than doubled in the past 30 years. Pregravid obesity alone however is not the only cause for concern since two-thirds of obese women gain weight in excess of the 2009 IOM recommendations and attempts to manage gestational weight gain to date have failed. To improve weight management of obese pregnant women, there is a critical need to deliver specific evidence-based recommendations on energy intake and energy expenditure (physical activity); the two primary determinants of weight gain in non-pregnant individuals. We evaluated energy intake and energy expenditure during pregnancy (13 to 37 weeks) and 12 months postpartum in up to 75 obese women.

Visit clinicaltrials.gov for more information on this study.


 

Participate While Pregnant Survey

Understanding feelings of participating in research studies while pregnant

Researchers at Pennington Biomedical Research Center would like to better understand how women feel about participating in reserach studies while they are pregnant. 

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Visit clinicaltrials.gov for more information on this study.


 

ART Survey

Assisted Reproductive Technology Survey

The National Institutes of Health has asked scientists to study the health and development of children conceived with the help of in vitro fertilization. Researchers at Pennington Biomedical would like to help! In preparation for a new study, the ART Survey collected information from families who have conceived with or without the help of IVF in our community.

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Visit clinicaltrials.gov for more information on this study.


 

"Mom2Baby" Pilot

Understanding the Influence of Pregnancy on Breast Milk

In 2010, more than a third of children in the U.S. aged two to five were overweight or obese. Obese youth are more likely to have risk factors for cardiovascular disease (high cholesterol and high blood pressure) and increased risk for diabetes. Maternal behaviors, especially those related to nutrition, should be targets for investigations to link early life biological factors to future obesity. Gestational health, incidence of breastfeeding, maternal food intake, and quality of breast milk should be evaluated for their effects on infant health and obesity risk throughout childhood. In the Mom2Baby Pilot study, we enrolled pregnant women who planned to breastfeed their infants until the infants are at least 2 months old. The purpose of this study is to identify the influences of pregnancy on breast milk and the effects of these on the health of the babies during the first 2 months of life.

 

Visit clinicaltrials.gov for more information on this study


 

"PULSE"

Effect of Weight and Insulin Sensitivity on Reproductive Function in PCOS

K99 HD060762/R00 awarded |R00HD060762

Up to 10% of women of reproductive age are affected by polycystic ovary syndrome (PCOS), an endocrinopathy characterized by excessive androgen production and reproductive dysfunction.  Since weight gain and excess adiposity exacerbate the androgen excess and reproductive dysfunction, weight loss by dietary restriction and exercise is the recommended treatment for infertility in overweight women with PCOS.  Our preliminary data indicate that exercise, independent of weight loss, restores menstrual cyclicity in obese women with PCOS. Moreover, treatment of PCOS patients with insulin sensitizers improved both androgen excess and ovulatory function without weight change.  We plan to conduct a randomized controlled clinical trial in 52 obese women with PCOS to determine the effects of: a) exercise training, b) 25% dietary restriction and c) metformin in comparison to d) a control group with no intervention.  In these subjects, we will measure: 1) neuroendocrine function (pulsatile LH secretion), 2) reproductive function (ovulation rate) and 3) ovarian function.

 

Visit clinicaltrials.gov for more information on this study.


 

"PULSE Ancillary"

Effect of Weight and Insulin Sensitivity on Reproductive Function in PCOS: Studies in Skeletal Muscle and Adipose Tissue

The overall objective of this ancillary study is to test in PULSE participants (overweight and obese women with polycystic ovary syndrome) the effect of 6 months of treatment with either: exercise training, 25% dietary restriction or metformin in comparison to a control group receiving no intervention on the functions of the skeletal muscle and adipose tissue. We will compare metabolic outcomes in the tissue samples between women randomized to a control group receiving no intervention and to those in the intervention groups.  We will also importantly evaluate, regardless of the assigned intervention, the association between weight loss, improvements in whole body insulin sensitivity (measured by the euglycemic hyperinsulinemic clamp) and changes tissue-specific substrate oxidation, insulin sensitivity and insulin signaling and mitochondrial function.

 

Visit clinicaltrials.gov for more information on this study.


 

"E-Moms"

E-Moms: A personalized telehealth intervention for health and weight loss in postpartum women

United States Department of Agriculture (through UCLA Small Grants Program)

Pre-pregnancy maternal overweight/obesity and excessive weight gain during pregnancy lead to significant morbidities in mothers and their offspring. Mothers who never return to their pre-pregnancy weight begin later pregnancies at a greater weight and have a larger possibility for excess gestational weight gain and postpartum weight retention. This vicious cycle is contributing to increased obesity among reproductive-aged women. Motherhood is increasingly recognized as a “teachable moment” for adopting a healthier lifestyle. While mothers are believed to be a highly motivated population for behavior change, pregnant women and new moms face several barriers to traditional in-person weight management programs.  Application of telehealth technologies to women during pregnancy and postpartum may successfully address these barriers and facilitate weight management. The objective of this study, titled “E-Moms: A personalized telehealth intervention for health and weight loss in postpartum women”, is to implement a personalized weight management program to overweight and obese postpartum women delivering health information based on the Women, Infants and Children periconceptional nutrition program. 

 

Visit clinicaltrials.gov for more information on this study.


 

"E-MECHANIC Ancillary"

Effect of exercise-induced weight loss on energy metabolism

The purpose of the E-MECHANIC Ancillary Study is to measure changes in daily energy expenditure with 24 weeks of exercise training (the metabolic adaptation to exercise training) and to determine if the metabolic adaptation to exercise is different between individuals who lost the predicted amount of weight (non-compensators) and individuals that did not lose the predicted amount of weight (compensators).    The E-MECHANIC study sponsored by the National Institutes of Health is conducting a randomized parallel arm study to understand the mechanisms that may explain exercise-induced weight change.  A total of 198 individuals overweight/obese individuals will be randomized into one of three groups for 24 weeks; non-exercise control group, low dose exercise training (exercise training dose will be set at 8 calories per kg of body weight per week, 8KKW) and high dose exercise training (exercise training dose will be set at 20 calories per kg of body weight per week, 20KKW). The primary outcome variables of E-MECHANIC are energy intake and the discrepancy between expected weight loss and observed weight loss. The secondary outcome variables include assessment of changes in resting metabolic rate and activity levels as potential mechanisms to explain differences in predicted and observed weight loss.  In the E-MECHANIC ancillary study, 24 hour energy expenditure and spontaneous physical activity will be measured in the metabolic chamber in a subset of 60 obese individuals (BMI: ≥30 kg/m2) enrolled in the main study.

 

Visit clinicaltrials.gov for more information on this study.


 

"Expecting Success"

Personalized Management of Body Weight During Pregnancy

3U01DK094481-01S1

More than 60% of reproductive age women in the US are overweight or obese and more than half exceed weight gain guidelines during pregnancy as recommended by the Institute of Medicine (IOM). Although pregnant women are believed to be a highly motivated population for accepting behavior change, they face several barriers to traditional in-person clinic weight management programs. The objective of this study is to implement a personalized gestational weight management program to overweight and obese pregnant women that focuses on healthy eating and achieving national physical activity recommendations.  We plan to enroll 306 overweight and obese pregnant women and randomly assign them to receive either usual care (Physician Directed Group) or a personalized lifestyle program for weight management called SmartMoms, delivered either in a traditional clinical setting (SmartMoms-Clinic) or remotely via a Smartphone (SmartMoms-Phone). 

 

Visit clinicaltrials.gov for more information on this study.


 

"ECCENTRIC"

Effect of Cinnamon Extract on Insulin Resistance in Polycystic Ovary Syndrome

Botanical Research Center Pilot Award

 

In vivo studies in skeletal muscle biopsies obtained from women with PCOS during fasted and insulin-stimulated (euglycemic hyperinsulinemic clamp) conditions indicate several post-insulin receptor defects in insulin signaling. Cinnamon, the bark of Cinnamoni Cassae is a potential mimetic of insulin action.  The molecular mechanisms by which cinnamon can influence glucose uptake are largely unknown.  Studies in laboratory animals and stable cells lines however, suggest that cinnamon can potentiate the action of insulin.  The objective of this study therefore is to evaluate for the first time, the effects of cinnamon on whole-body insulin-stimulated glucose uptake using the gold standard, euglycemic hyperinsulinemic clamp and insulin signaling in skeletal muscle.

Visit clinicaltrials.gov for more information on this study.


 

"Baby Bottle"

Remote Food Photography with Infants: A Pilot Study

Food intake is crucial during the first two years of life because it is a time of constant growth and development. Measuring food intake in infants is challenging due to constant changes in eating patterns and large variability in food selection. Establishing accurate methods to estimate food intake in infants is important for establishing effective feeding practices, supporting adequate growth and development and to help understand the role of food intake in the development of childhood obesity. Digital photography and the Remote Food Photography Method (RFPM) is used to measure energy and nutrient intake in adults, but these methods have not been used to measure energy and nutrient intake in infants from birth to 12 months. The primary objective of this study is to determine the reliability and validity of the RFPM to assess food intake in formula fed infants.

Visit clinicaltrials.gov for more information on this study


 

“MAX”

Max II Metabolic Cart Validation

The objective of this study, “MAX,” is to establish the accuracy and reliability of Max II metabolic cart (AEI Technologies, Naperville, II) for measuring resting metabolic rate in humans in comparison to the Deltatrac II metabolic cart, a widely accepted metabolic measurement system which is no longer serviceable.

 

Visit clinicaltrials.gov for more information on this study.

 

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