The Effects of the Food Preservative Propionic Acid in Post-prandial Metabolism

Obesity Clinical Trial

— Walnut  

Official title:

Pilot Study to Study the Effects of the Food Preservative Calcium Propionate on Postprandial Hormonal and Metabolic Milieu

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01889446
• Other study ID #: 2013P001197
• Status: Recruiting
• Phase: N/A
• First received: June 26, 2013
• Last updated: September 19, 2014
• Start date: August 2013
• Est. completion date: June 2015

Study information

• Verified date: September 2014
• Source: Brigham and Women's Hospital
• Contact: Amir Tirosh, MD PhD
• Email: ATIROSH[@]PARTNERS.ORG
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Propionic acid (PA) is used as a preservative in foods such as cheeses, baked goods, or additive for artificial fruit flavors. The U.S. Environmental Protection Agency considers it safe and therefore, has no limitation on its use. Since PA has been shown before to serve as a substrate for glucose production in the liver, the purpose of this study is to find out if PA intake causes changes in levels of glucose, insulin and other important hormones following a meal.

This research study will compare PA to placebo. The placebo looks exactly like the active substance, but it does not contain any active agent (PA). Placebos are used in research studies to see if the results are due to the study drug or to other reasons.

The investigators plan to have 20 subjects take part in this study at the Brigham and Women's Hospital (BWH).

Description:

-To test whether PA, added as food supplement to humans, results in altered post-prandial metabolism. The investigators propose to conduct a double-blind, randomized, placebo controlled, cross-over study in which blood levels of metabolites and hormones will be measured in healthy volunteers following a mixed meal test without or with PA.

Study design:

This is a double-blind, randomized, placebo controlled, cross-over study. Twenty volunteers who meet the inclusion/exclusion criteria will be randomized into two groups, provided with a mixed meal without or with calcium proprionate (also known as E282). A week later, participants will be provided with a mixed meal again, following cross-over of the groups. Blood will be collected at baseline, and every 30 minutes for 4 hours.

Study Subjects:

20 healthy male and female volunteers (ages 18 to 65 years) with a body mass index (BMI) of 20 to <30 Kg/m2.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age 18-65 years

• Good health as evidenced by history and physical exam

• BMI: 20-29.9 kg/m2

Exclusion Criteria:

• Fasting plasma glucose >110 mg/dL

• HbA1c >6.0%

• Significant current illness other than treated hypothyroidism

• BP >135/85 or systolic BP <90 mm Hg

• Hepatic disease (transaminase > 3 times normal)

• Renal impairment (Creatinine clearance <60 ml/min)

• History of drug or alcohol abuse

• Participation in any other concurrent clinical trial

• Pregnant women

• History of food allergies.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes
• Insulin Resistance
• Obesity

Intervention

Dietary Supplement:
• Calcium propionate

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post prandial insulin levels		During 4 hours after consumption of a meal	No