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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01889446
Recruitment Status : Unknown
Verified September 2014 by Amir Tirosh, Brigham and Women's Hospital.
Recruitment status was:  Recruiting
First Posted : June 28, 2013
Last Update Posted : September 22, 2014
Sponsor:
Information provided by (Responsible Party):
Amir Tirosh, Brigham and Women's Hospital

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).


Condition or disease Intervention/treatment Phase
Obesity Insulin Resistance Diabetes Dietary Supplement: Calcium propionate Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Pilot Study to Study the Effects of the Food Preservative Calcium Propionate on Postprandial Hormonal and Metabolic Milieu
Study Start Date : August 2013
Estimated Primary Completion Date : June 2015
Estimated Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium

Arm Intervention/treatment
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'.
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.



Primary Outcome Measures :
  1. Post prandial insulin levels [ Time Frame: During 4 hours after consumption of a meal ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01889446


Contacts
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Contact: Amir Tirosh, MD PhD ATIROSH@PARTNERS.ORG
Contact: Kyle Carbone kcarbone3@partners.org

Locations
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United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Principal Investigator: Amir Tirosh, MD PhD         
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
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Principal Investigator: Amir Tirosh, MD PhD Brigham and Women's Hospital

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Responsible Party: Amir Tirosh, MD,PhD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01889446    
Other Study ID Numbers: 2013P001197
First Posted: June 28, 2013    Key Record Dates
Last Update Posted: September 22, 2014
Last Verified: September 2014
Keywords provided by Amir Tirosh, Brigham and Women's Hospital:
Propionic acid
Food preservatives
Additional relevant MeSH terms:
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Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Calcium, Dietary
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents