Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
13 participants
INTERVENTIONAL
2010-08-31
2011-12-31
Brief Summary
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Detailed Description
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Benzoate salts are widely used preservatives in products such as sodas, canned goods, and pharmaceuticals. Interestingly, there is published evidence that sodium benzoate and its metabolite hippurate can affect pancreatic islet function and impair glucose tolerance. However, the effects of oral sodium benzoate at concentrations typically used in our diet on glucose homeostasis have not been systematically studied. Here, we propose to close this knowledge gap.
We will recruit 15 healthy, overweight volunteers, age 18-35. Each subject will receive 4 interventions: an oral glucose challenge 1) with and 2) without 0.1% benzoic acid, and a drink of water 3) with and 4) without 0.1% benzoic acid. Blood samples will be analyzed for glucose, insulin, glucagon, and a panel of approximately 300 different metabolites at baseline and serially for 2 hours after each intervention. Factorial analysis of variance will be performed to determine the effects of benzoic acid in the presence and absence of glucose, and interactions between glucose and benzoate. The planned sample size of 15 will provide 80% power to detect an effect-size of 0.16 standard-deviations in outcome measures, and an interaction-effect of 0.33 standard-deviations, with a critical value p=0.05.
If we find through this study that sodium benzoate significantly affects glucose tolerance, the public health implications would be great. High level, frequent consumption might cause diseases associated with insulin resistance, chiefly T2DM. Furthermore, its presence in OGTT testing solutions could provide misleading results.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
TRIPLE
Study Groups
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sodium benzoate containing
benzoate containing test drinks
Subjects will consume 500ml of water with 0.5 grams of sodium benzoate, followed by a solution of 75g sugar in 500ml water with 0.5 grams sodium benzoate 3 hours later.
Each solution will be consumed over 5 minutes.
non sodium benzoate containing
non sodium benzoate containing test drinks
Subjects will consume 500ml of water followed by a solution of 75g sugar in 500ml water 3 hours later.
Each solution will be consumed over 5 minutes.
Interventions
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benzoate containing test drinks
Subjects will consume 500ml of water with 0.5 grams of sodium benzoate, followed by a solution of 75g sugar in 500ml water with 0.5 grams sodium benzoate 3 hours later.
Each solution will be consumed over 5 minutes.
non sodium benzoate containing test drinks
Subjects will consume 500ml of water followed by a solution of 75g sugar in 500ml water 3 hours later.
Each solution will be consumed over 5 minutes.
Eligibility Criteria
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Inclusion Criteria
* BMI 25-30
Exclusion Criteria
* 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
18 Years
35 Years
ALL
Yes
Sponsors
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Massachusetts General Hospital
OTHER
Boston Children's Hospital
OTHER
Responsible Party
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Principal Investigators
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David S Ludwig, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Boston Children's Hospital
Vamsi Mootha, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Belinda S Lennerz, MD, PhD
Role: STUDY_DIRECTOR
Boston Children's Hospital
Scott Vafai, MD
Role: STUDY_DIRECTOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Children's Hospital
Boston, Massachusetts, United States
Countries
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Other Identifiers
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10-05-0202
Identifier Type: -
Identifier Source: org_study_id