Effects of a Food Preservative on Glucose Homeostasis

NCT01179945 | Completed

• 1 other identifier: 10-05-0202
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 2

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 increased diabetes risk could be counseled to avoid this preservative.

Conditions

Overweight

Keywords

diabetes; benzoic acid; benzoate; soda; soft drink; preservative; blood sugar

Outcome Measures

Primary Outcomes (1)

• Blood glucose area under the curve (AUC)

  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.

  120 minutes post ingestion

Secondary Outcomes (3)

• Insulin AUC

  120 minutes

• Glucagon AUC

  120 minutes

• Metabolite Profiles

  120 minutes

Study Arms (2)

sodium benzoate containing

EXPERIMENTAL

Other: benzoate containing test drinks

non sodium benzoate containing

ACTIVE COMPARATOR

Other: non sodium benzoate containing test drinks

Interventions

benzoate containing test drinks OTHER

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.

sodium benzoate containing

non sodium benzoate containing test drinks OTHER

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.

non sodium benzoate containing

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Men and women age 18-35
• BMI 25-30

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Children's Hospital: lead
• Massachusetts General Hospital: collaborator

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02101, United States

Location

Children's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Overweight; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Officials

• David S Ludwig, MD, PhD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

• Vamsi Mootha, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• Belinda S Lennerz, MD, PhD

  Boston Children's Hospital

  STUDY DIRECTOR

• Scott Vafai, MD

  Massachusetts General Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2010
• First Posted: August 11, 2010
• Study Start: August 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: December 1, 2011
• Last Updated: October 1, 2012

Record last verified: 2012-09

Locations

US (2)