ObesityWalnutNCT01889446
The Effects of the Food Preservative Propionic Acid in Post-prandial Metabolism
A study testing Calcium propionate in people with Obesity and Insulin Resistance, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Insulin Resistance, Diabetes
- What is being tested?
- Calcium propionate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-65 years
- Good health as evidenced by history and physical exam
- BMI: 20-29.9 kg/m2
Who cannot join
- 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)
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- History of drug or alcohol abuse
- Participation in any other concurrent clinical trial
- Pregnant women
- History of food allergies.
Trial locations and contacts
1 site in 1 country.
Amir Tirosh, MD PhD contact
Kyle Carbone contact
United States1 site, 1 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Amir Tirosh, MD PhD
About this study
Official title: Pilot Study to Study the Effects of the Food Preservative Calcium Propionate on Postprandial Hormonal and Metabolic Milieu
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).
Read the 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.
- Conditions
- Obesity, Insulin Resistance, Diabetes
- Being tested
- Calcium propionate
- Keywords
- Propionic acid, Food preservatives
- Medical subject headings
- Obesity, Insulin Resistance, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium propionateDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| 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'. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post prandial insulin levels
Measured: During 4 hours after consumption of a meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2013 (estimated)
- Study startAug 2013
- Primary completionJun 2015 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amir Tirosh, Brigham and Women's Hospital
- Investigators
- Amir Tirosh, MD PhD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01889446
- Sponsor's protocol ID
- 2013P001197
- Acronym
- Walnut
- Status last verified
- Sep 2014
- First submitted
- 26 Jun 2013
- Last updated
- 22 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Study the Effects of the Food Preservative Calcium Propionate on Postprandial Hormonal and Metabolic Milieu
- ClinicalTrials.gov ID
- NCT01889446
- Acronym / sponsor ID
- Walnut / 2013P001197
- Conditions
- Obesity, Insulin Resistance, Diabetes
- Keywords
- Propionic acid, Food preservatives
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 28 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Calcium propionate | Placebo comparator | Dietary Supplement: Calcium propionateAddition 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 | 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-65 years
- Good health as evidenced by history and physical exam
- BMI: 20-29.9 kg/m2
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calcium propionate | Dietary supplement | Calcium propionate |
Primary outcome
Post prandial insulin levels
Time frame: During 4 hours after consumption of a meal
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amir Tirosh, MD PhD contact
Kyle Carbone contact
Amir Tirosh, MD PhD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calcium propionate in people with Obesity and Insulin Resistance, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amir Tirosh, MD PhD (ATIROSH@PARTNERS.ORG), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post prandial insulin levels (time frame: During 4 hours after consumption of a meal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2014.