NCT01889446

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Aug 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 28, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

September 22, 2014

Status Verified

September 1, 2014

Enrollment Period

1.8 years

First QC Date

June 26, 2013

Last Update Submit

September 19, 2014

Conditions

ObesityInsulin ResistanceDiabetes

Keywords

Propionic acidFood preservatives

Outcome Measures

Primary Outcomes (1)

  • Post prandial insulin levels

    During 4 hours after consumption of a meal

Study Arms (2)

Calcium propionate

PLACEBO COMPARATOR

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

PLACEBO COMPARATOR

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 propionateDIETARY_SUPPLEMENT
Calcium propionate

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-65 years
  • Good health as evidenced by history and physical exam
  • BMI: 20-29.9 kg/m2

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

ObesityInsulin ResistanceDiabetes Mellitus

Interventions

calcium propionate

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Study Officials

  • Amir Tirosh, MD PhD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amir Tirosh, MD PhD

CONTACT

ATIROSH@PARTNERS.ORG

Kyle Carbone

CONTACT

kcarbone3@partners.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD,PhD

Study Record Dates

First Submitted

June 26, 2013

First Posted

June 28, 2013

Study Start

August 1, 2013

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

September 22, 2014

Record last verified: 2014-09

Locations

US(1)