Status:

COMPLETED

Effects of a Food Preservative on Glucose Homeostasis

Lead Sponsor:

Boston Children's Hospital

Collaborating Sponsors:

Massachusetts General Hospital

Conditions:

Overweight

Eligibility:

All Genders

18-35 years

Phase:

NA

Brief Summary

The investigators propose to examine the effects of the common food preservative sodium benzoate on blood glucose and related hormones and metabolites. If an effect is demonstrated, patients with incr...

Detailed Description

Soft drink consumption has been repeatedly implicated in the development of type 2 diabetes (T2DM). Interestingly, epidemiology studies have yielded inconsistent results. Some studies identify sugar-s...

Eligibility Criteria

Inclusion

  • Men and women age 18-35
  • BMI 25-30

Exclusion

  • Diabetes Mellitus (fasting Blood Glucose ≥ 126mg/dl)
  • Exercise more than 60 minutes more that 4 times a week
  • Major medical illness
  • Medications or supplements that can influence glucose metabolism
  • Large fluctuations in weight (\>5% over the past 6 months)
  • Currently following a weight loss program
  • Consumption of more than 24 ounces of soda per day (defined as sugar- or artificially sweetened beverages, e.g. colas or fruit punches, excluding hot tea and coffee)
  • Allergy or intolerance to sodium benzoate
  • Nicotine use
  • Illicit substance use
  • Women with irregular menstrual cycles, or who are pregnant or breastfeeding

Key Trial Info

Start Date :

August 1 2010

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2011

Estimated Enrollment :

13 Patients enrolled

Trial Details

Trial ID

NCT01179945

Start Date

August 1 2010

End Date

December 1 2011

Last Update

October 1 2012

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Massachusetts General Hospital

Boston, Massachusetts, United States, 02101

2

Children's Hospital

Boston, Massachusetts, United States, 02115