Effects of a Food Preservative on Glucose Homeostasis

This study has been completed.
Sponsor:
Collaborator:
Massachusetts General Hospital
Information provided by (Responsible Party):
Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT01179945
First received: August 10, 2010
Last updated: September 28, 2012
Last verified: September 2012
  Purpose

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 increased diabetes risk could be counseled to avoid this preservative.


Condition Intervention
Overweight
Other: benzoate containing test drinks
Other: non sodium benzoate containing test drinks

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Effects of a Food Preservative on Glucose Homeostasis

Resource links provided by NLM:


Further study details as provided by Children's Hospital Boston:

Primary Outcome Measures:
  • Blood glucose area under the curve (AUC) [ Time Frame: 120 minutes post ingestion ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Insulin AUC [ Time Frame: 120 minutes ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 13
Study Start Date: August 2010
Study Completion Date: December 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


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-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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01179945

Locations
United States, Massachusetts
Children's Hospital
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02101
Sponsors and Collaborators
Children's Hospital Boston
Massachusetts General Hospital
Investigators
Principal Investigator: David S Ludwig, MD, PhD Children's Hospital Boston
Principal Investigator: Vamsi Mootha, MD Massachusetts General Hospital
Study Director: Belinda S Lennerz, MD, PhD Children's Hospital Boston
Study Director: Scott Vafai, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT01179945     History of Changes
Other Study ID Numbers: 10-05-0202
Study First Received: August 10, 2010
Last Updated: September 28, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Children's Hospital Boston:
diabetes
benzoic acid
benzoate
soda
soft drink
preservative
blood sugar

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 21, 2014