Recruiting

Propionic Acid

Sponsor:

Brigham and Women's Hospital

Code:

NCT01889446

Conditions

Obesity

Insulin Resistance

Diabetes

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Calcium propionate

Study Details

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).

Conditions

Obesity

Insulin Resistance

Diabetes

Study ID

NCT01889446

Start date

Aug, 2013

Status verified date

Sep, 2014

Completion date

Jun, 2015

Anticipated

Primary completion date

Jun, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

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'.

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.

Interventions

Calcium propionate

Primary outcome measure

  • Post prandial insulin levels [ Time Frame: During 4 hours after consumption of a meal ]

Central Contacts and Locations

Central contacts

Amir Tirosh, MD PhD

ATIROSH@PARTNERS.ORG

Kyle Carbone

kcarbone3@partners.org

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Principal Investigator:

Amir Tirosh, MD PhD

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Sep 22, 2014

Last verified

Sep, 2014

Keywords

  • Propionic acid
  • Food preservatives

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2014-09-22.