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Dietary Sugars Found In Breast Milk

NCT02940795 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2017-01-24

No results posted yet for this study

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.

Conditions

  • Lactation

Interventions

OTHER

Coke

Patients were given a 20 ounce bottle of Coke Cola.

OTHER

Diet Rite

Patients were given a 12 ounce can of Diet Rite.

Sponsors & Collaborators

  • University of Oklahoma

    lead OTHER

Principal Investigators

  • David A Fields, PhD · University of Oklahoma

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2016-06-30
Completion
2016-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02940795 on ClinicalTrials.gov