Effects of a Food Preservative on Glucose Homeostasis
|ClinicalTrials.gov Identifier: NCT01179945|
Recruitment Status : Completed
First Posted : August 11, 2010
Last Update Posted : October 1, 2012
|Condition or disease||Intervention/treatment||Phase|
|Overweight||Other: benzoate containing test drinks Other: non sodium benzoate containing test drinks||Not Applicable|
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-sweetened beverages as the culprit, whereas others point towards artificially-sweetened beverages. Beyond differences in methodology, these conflicting reports raise the question whether another ingredient common to both sugar and artificially-sweetened soft drinks, such as a preservative, might play a role.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Effects of a Food Preservative on Glucose Homeostasis|
|Study Start Date :||August 2010|
|Actual Primary Completion Date :||August 2011|
|Actual Study Completion Date :||December 2011|
|Experimental: sodium benzoate containing||
Other: 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.
|Active Comparator: non sodium benzoate containing||
Other: 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.
- Blood glucose area under the curve (AUC) [ Time Frame: 120 minutes post ingestion ]Plasma glucose will be measured at baseline, 15, 30, 45, 60, 90, and 120 minutes post ingestion of each test solution, and area under the curve will be calculated.
- Insulin AUC [ Time Frame: 120 minutes ]Serum Insulin will be measured at baseline, 15, 30, 45, 60, 90, and 120 minutes post ingestion of each test solution, and area under the curve will be calculated.
- Glucagon AUC [ Time Frame: 120 minutes ]Plasma Glucagon will be measured at baseline, 15, 30, 45, 60, 90, and 120 minutes post ingestion of each test solution, and area under the curve will be calculated.
- Metabolite Profiles [ Time Frame: 120 minutes ]Metabolite analysis will be performed on blood samples at baseline, 15, 30, 45, 60, 90, and 120 minutes post ingestion of each test solution, and area under the curve will be calculated.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01179945
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02101|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||David S Ludwig, MD, PhD||Boston Children’s Hospital|
|Principal Investigator:||Vamsi Mootha, MD||Massachusetts General Hospital|
|Study Director:||Belinda S Lennerz, MD, PhD||Boston Children’s Hospital|
|Study Director:||Scott Vafai, MD||Massachusetts General Hospital|