Dietary Sugars Found In Breast Milk

NCT02940795 | Completed DMC

• 1 other identifier: 5297
• Study Type: interventional
• Target: 41
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

breast feeding; fructose

Outcome Measures

Primary Outcomes (2)

• Fructose in breast milk will be measured in human breast milk at one month.

  Breast milk fructose at one month will be analyzed.

  One month

• The change in fructose in breast milk from one to six months.

  The potential change in breast milk fructose from one to six months will be investigated.

  Six months

Secondary Outcomes (1)

• Breast milk fructose will be measured after the ingestion of a regular 20 ounce bottle of coke and a 12 ounce can of diet rite.

  6 hours.

Study Arms (2)

Coke cola

EXPERIMENTAL

Exclusively lactating mothers with infants between 4-6 weeks were investigated. Lactating mothers will be consume a 20 ounce bottle of coke cola.

Other: Coke; Other: Diet Rite

Diet Rite

EXPERIMENTAL

Exclusively lactating mothers with infants between 4-6 weeks were asked to consume a 12 ounce bottle of diet rite.

Other: Coke; Other: Diet Rite

Interventions

Coke OTHER

Patients were given a 20 ounce bottle of Coke Cola.

Coke cola; Diet Rite

Diet Rite OTHER

Patients were given a 12 ounce can of Diet Rite.

Coke cola; Diet Rite

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Exclusively lactating mothers
• Mothers must be 3 weeks to 6 weeks postpartum

You may not qualify if:

• Smoked during pregnancy or are currently smoking
• Unable to provide breast milk samples using a breast pump

Sponsors & Collaborators

• University of Oklahoma: lead

Related Publications (1)

• Rother KI, Sylvetsky AC, Walter PJ, Garraffo HM, Fields DA. Pharmacokinetics of Sucralose and Acesulfame-Potassium in Breast Milk Following Ingestion of Diet Soda. J Pediatr Gastroenterol Nutr. 2018 Mar;66(3):466-470. doi: 10.1097/MPG.0000000000001817.

  PMID: 29077645 DERIVED

MeSH Terms

Conditions

Breast Feeding

Interventions

Coke

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Coal; Fossil Fuels; Complex Mixtures; Energy-Generating Resources; Environment; Environment and Public Health

Study Officials

• David A Fields, PhD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 14, 2016
• First Posted: October 21, 2016
• Study Start: April 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 24, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share