Clinical trial NCT01889446: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Insulin Resistance
Diabetes
Keywords: Propionic acid
Food preservatives
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2013-06-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: Post prandial insulin levels
timeFrame: During 4 hours after consumption of a meal
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Amir Tirosh, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: