Clinical Trials Logo

Clinical Trial Summary

The majority of pregnant women in the United States are either overweight or obese at conception with their offspring having greater adiposity at birth, a 2-fold greater risk of later obesity and neonatal insulin resistance.

Conventional wisdom holds that breast-milk composition is uniform; recently our group has questioned this. An increase in consumption of dietary sugars including fructose over the past 30 years has risen, and this has been associated with chronic metabolic and endocrine disorders and phenotypic alterations that promote obesity and diabetes. However, no prior studies have examined how maternal increases of sugars/fructose during lactation affects breast-milk composition with potential transmission to the infant. The objective of this proposal is to comprehensively assess the presence and pharmacokinetics of sugars, including fructose in human breast-milk in response to maternal consumption. The central hypothesis is that a graded, dose-response relationship be-tween maternal adiposity and sugar concentrations in breast-milk exist and that milk fructose concentrations are associated with altered body composition in the first months of life. This proposal, guided by compelling preliminary data will examine the evidence linking high intakes of milk fructose with altered metabolism and early obesity by pursuing two Specific Aims: 1) Test novel relationships between breast-milk sugars and changes in infant fat mass and 2) Characterize the pharmacokinetics of milk sugars after consuming a 20 oz. cola. These aims are significant given the intractability of obesity/diabetes and a potentially identifiable novel target, making for a clear but powerful public message to reduce sugary beverage consumption during lactation.


Clinical Trial Description

One of the most highly effective preventive measures a mother can make in protecting the health of her infant and herself is to breastfeed. Despite extensive research on breast-milk, limited information beyond basic micro/macronutrient composition currently exists in the literature. Breast-milk is a complex, non-uniform biological substance. In prior studies the PI has shown significant associations be-tween non-nutritive constituents in breast-milk (e.g. IL-6, TNF-α, insulin, leptin) and body composition in infants starting at 4wks of age. The putative causal influence of breastfeeding reducing obesity is mixed with no clear probative evidence showing causal pathways. Despite many studies in this area, there are no detailed studies that have examined the potential modifying role of maternal diet, especially one high in sugars on the compositional makeup of the three largest breast-milk sugars (glucose, galactose and lactose) with none to date looking at fructose. Animal models have demonstrated that the obesogenic effect of maternal fructose consumption is transmitted to offspring via breast-milk with fructose-fed lactating dams producing offspring with double fasting insulin levels compared to control pups. This is relevant in humans because of the increase in dietary sugar consumption that has occurred in the population.

A mother/infant cohort (n=37) has been established with detailed infant phenotypic body composition (dual-energy X-ray absorptiometry) and detailed breast-milk analysis (insulin, leptin, IL-6, TNF-α but no milk sugars other than glucose) in exclusively breast feeding mothers varying widely in BMI (19 to 44 kg/m2). Sampling of breast-milk and infant body composition occurred at both 4 and 24wks. As a proof of concept, fructose was detected in breast-milk from 9 of these mothers which was significantly related to infant body fat, which is a novel finding to date and has never been reported in the literature. Building upon this prior work this study will determine the concentration and pharmacokinetics of breast-milk sugars after a test beverage is consumed. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02940795
Study type Interventional
Source University of Oklahoma
Contact
Status Completed
Phase N/A
Start date April 2016
Completion date December 2016

See also
  Status Clinical Trial Phase
Completed NCT02542527 - Evaluation of the Functionality of a Fluid Filled Single Breast Pump N/A
Terminated NCT02755194 - "Drugs in Lactation" Analysis Consortium
Terminated NCT00851591 - Effect of Fenugreek on Milk Production N/A
Withdrawn NCT00181649 - Recombinant Human Prolactin for Lactation Induction Phase 2
Completed NCT00181610 - Recombinant Human Prolactin for Lactation Induction Phase 2
Completed NCT04024865 - Domperidone and Risk of Serious Cardiac Events in Postpartum Women
Terminated NCT02378233 - Iodine Status in Swedish Lactating Women - Effect of Iodine Supplementation in the Thyroid Function of Mother and Infant N/A
Recruiting NCT06203444 - An Open-label Study to Evaluate the Pharmacokinetics of Oral Tenapanor in Breast Milk of Lactating Females Phase 1
Completed NCT01747668 - Lactation Fortification Study Phase 3
Completed NCT02621827 - Vitamin D Half-life in Pregnancy and Lactation N/A
Completed NCT01463202 - Timing of Postpartum Depot Medroxyprogesterone Acetate Administration on Breastfeeding, Contraceptive Continuation, and Depression Phase 4
Terminated NCT04146909 - The Effect of Lactation on Insulin Sensitivity and Lipolysis in Women N/A
Completed NCT04593719 - Effect of Lactation Management Model on Breastfeeding Process N/A
Completed NCT01548313 - The Role of Human Milk in Development of Breast Fed Child's Intestinal Microbiota
Completed NCT02690675 - Iron Supplement Effect on Child Development N/A
Completed NCT05123183 - Nonpharmacological Methods and Lactation N/A
Completed NCT03091985 - Influence of the Brownie Breast Shield on the Dynamics of Milk Removal N/A
Completed NCT02190448 - Randomized, Placebo-Controlled Study of an Herbal Tea to Support Lactation N/A
Not yet recruiting NCT06264349 - Women and Maternity: Development of a Nutritional Education Project N/A
Recruiting NCT02384655 - Effect of Fenugreek Use in Mothers of Preterm on Breast Milk Production and Macronutrient Content Phase 1/Phase 2