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

• ClinicalTrials.gov Identifier: NCT01889446
• Recruitment Status: Unknown
• First Posted: June 28, 2013
• Last Update Posted: September 22, 2014
• Sponsor: Brigham and Women's Hospital
• Information provided by (Responsible Party): Amir Tirosh, Brigham and Women's Hospital

Tracking Information

• First Submitted Date: June 26, 2013
• First Posted Date: June 28, 2013
• Last Update Posted Date: September 22, 2014
• Study Start Date: August 2013
• Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 27, 2013): Post prandial insulin levels [ Time Frame: During 4 hours after consumption of a meal ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Effects of the Food Preservative Propionic Acid in Post-prandial Metabolism
• Official Title: Pilot Study to Study the Effects of the Food Preservative Calcium Propionate on Postprandial Hormonal and Metabolic Milieu

Brief 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).

Detailed 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Basic Science

Condition

• Obesity
• Insulin Resistance
• Diabetes

• Intervention: Dietary Supplement: Calcium propionate

Study Arms

• Placebo Comparator: Calcium propionate
  Addition of calcium propionate (PA arm) in a capsule (1000 mg) consumed together with a mixed meal of 500 kCal in the morning following an overnight fast. Blood is taken at baseline and every 30 minutes for 4 hours. This arm is compared to a placebo capsule (following identical protocol). Following a washout period of a week, the arms will be crossed over and the PA arm participants will repeat the same protocol in the 'placebo arm'.
  Intervention: Dietary Supplement: Calcium propionate
• Placebo Comparator: Placebo
  Addition of placebo (PA arm) in a capsule consumed together with a mixed meal of 500 kCal in the morning following an overnight fast. Blood is taken at baseline and every 30 minutes for 4 hours. This arm is compared to the PA arm (PA, 1000 mg in a capsule). Following a washout period of a week, the arms will be crossed over and the PA arm participants will repeat the same protocol in the 'placebo arm', and vice versa.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: June 27, 2013): 20
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 2015
• Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01889446
• Other Study ID Numbers: 2013P001197
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Amir Tirosh, Brigham and Women's Hospital
• Study Sponsor: Brigham and Women's Hospital
• Collaborators: Not Provided

Investigators

• Principal Investigator: Amir Tirosh, MD PhD; Brigham and Women's Hospital

• PRS Account: Brigham and Women's Hospital
• Verification Date: September 2014