Endothelial DysfunctionNCT03801486
Effects of Incorporating Sprouted and Non-sprouted Chickpea Flour in Pasta Products Analyzed in Vivo Flow-mediated Dilation
An observational study of Endothelial Dysfunction, run by Montclair State University.
Trial summary
The investigators examined the effects on post-digestion brachial artery flow mediated dilation (FMD) and in vitro antioxidant capacity of 40% semolina flour replacement with sprouted chickpea flour. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Endothelial Dysfunction
- What is being tested?
- Experimental: Sprouted Chickpea Flour
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- 2 Mar 2016to 1 May 2017
- Phase
- Observational
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy adults
Who may be able to join
- healthy adult
Who cannot join
- have diabetes mellitus, kidney disease, a history of cancer, cardiac issues, pulmonary disease, history of a stroke, obesity (for most people this means a body mass index greater than 30), or any life threatening chronic conditions.
- food allergies relevant to wheat, gluten, chickpea, and pasta sauce.
- are currently being treated for infectious mononucleosis, hepatitis, pneumonia, or other infectious diseases.
- are unable or unwilling to refrain from recreational drug (marijuana, cocaine, etc.) or alcohol use during the 24 hours prior to your exercise session.
- use nicotine products, or non-contraceptive hormonal therapy (birth control is okay).
- are pregnant or trying to become pregnant.
About this study
Official title: The Effects of Incorporating Sprouted and Non-sprouted Chickpea Flour in Pasta Products Analyzed in Vivo Flow-mediated Dilation
The investigators examined the effects on post-digestion brachial artery flow mediated dilation (FMD) and in vitro antioxidant capacity of 40% semolina flour replacement with sprouted chickpea flour.
Read the detailed description
The purpose of the current study was to examine in-vitro and in-vivo effects of replacing 40% of semolina flour with sprouted chickpea flour for the use in pasta. Antioxidant capacity in-vitro was measured by Trolox Equivalent Antioxidant Capacity. Brachial artery flow-mediated dilation, a test of in-vivo endothelial function, was performed for assessment of effects on post-digestion endothelial function. The investigators hypothesized that FMD would be higher after consuming 40% of semolina flour with sprouted chickpea flour pasta vs. 100% of semolina flour pasta.
- Conditions
- Endothelial Dysfunction
- Being tested
- Experimental: Sprouted Chickpea Flour, Control: Semolina Flour
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Sprouted Chickpea FlourOther
Also called SCF40
255g of pasta with 40% sprouted chickpea flour and 60% semolina flour (SCF40) with butter.
Control: Semolina FlourOther
Also called SEM100
255g of pasta with 100% semolina flour (SEM100) with butter.
| Study group | Role | What they receive |
|---|---|---|
| Experimental (SCF40) | At the experimental data collection visits participants consumed 255g of pasta made with 40% sprouted chickpea flour and 60% semolina flour (SCF40) with butter. Receives: Other: Experimental: Sprouted Chickpea Flour | |
| Control (SEM100) | At the control data collection visits participants consumed 255g of pasta made with 100% semolina flour (SEM100) with butter. Receives: Other: Control: Semolina Flour |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-digestion flow mediated dilation
Post meal
Measured: Two hours following meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2019
- Study start2 Mar 2016
- Primary completion1 May 2017
- Study completion1 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endothelial DysfunctionStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montclair State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03801486
- Sponsor's protocol ID
- 15-16-133
- Status last verified
- Jan 2019
- First submitted
- 9 Jan 2019
- Last updated
- 30 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bruno JA, Feldman CH, Konas DW, Kerrihard AL, Matthews EL. Incorporating sprouted chickpea flour in pasta increases brachial artery flow-mediated dilation. Physiol Int. 2019 Sep 1;106(3):207-212. doi: 10.1556/2060.106.2019.21. Epub 2019 Sep 30.
PubMed 31564118
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Incorporating Sprouted and Non-sprouted Chickpea Flour in Pasta Products Analyzed in Vivo Flow-mediated Dilation
- ClinicalTrials.gov ID
- NCT03801486
- Acronym / sponsor ID
- 15-16-133
- Conditions
- Endothelial Dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Montclair State UniversityUniversity, hospital or other
- Study start
- 2 Mar 2016 (actual)
- Primary completion
- 1 May 2017 (actual)
- Study completion
- 1 May 2017 (actual)
- First posted
- 11 Jan 2019 (actual)
- 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.
The investigators examined the effects on post-digestion brachial artery flow mediated dilation (FMD) and in vitro antioxidant capacity of 40% semolina flour replacement with sprouted chickpea flour.
Detailed description
The purpose of the current study was to examine in-vitro and in-vivo effects of replacing 40% of semolina flour with sprouted chickpea flour for the use in pasta. Antioxidant capacity in-vitro was measured by Trolox Equivalent Antioxidant Capacity. Brachial artery flow-mediated dilation, a test of in-vivo endothelial function, was performed for assessment of effects on post-digestion endothelial function. The investigators hypothesized that FMD would be higher after consuming 40% of semolina flour with sprouted chickpea flour pasta vs. 100% of semolina flour pasta.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental (SCF40) | – | Other: Experimental: Sprouted Chickpea FlourAt the experimental data collection visits participants consumed 255g of pasta made with 40% sprouted chickpea flour and 60% semolina flour (SCF40) with butter. |
| Control (SEM100) | – | Other: Control: Semolina FlourAt the control data collection visits participants consumed 255g of pasta made with 100% semolina flour (SEM100) with butter. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy adults
Key inclusion criteria (1 listed)
- healthy adult
Key exclusion criteria (6 listed)
- have diabetes mellitus, kidney disease, a history of cancer, cardiac issues, pulmonary disease, history of a stroke, obesity (for most people this means a body mass index greater than 30), or any life threatening chronic conditions.
- food allergies relevant to wheat, gluten, chickpea, and pasta sauce.
- are currently being treated for infectious mononucleosis, hepatitis, pneumonia, or other infectious diseases.
- are unable or unwilling to refrain from recreational drug (marijuana, cocaine, etc.) or alcohol use during the 24 hours prior to your exercise session.
- use nicotine products, or non-contraceptive hormonal therapy (birth control is okay).
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 |
|---|---|---|
| Experimental: Sprouted Chickpea FlourAlso: SCF40255g of pasta with 40% sprouted chickpea flour and 60% semolina flour (SCF40) with butter. | Other | Experimental (SCF40) |
| Control: Semolina FlourAlso: SEM100255g of pasta with 100% semolina flour (SEM100) with butter. | Other | Control (SEM100) |
Primary outcome
Post-digestion flow mediated dilation
Time frame: Two hours following meal
Post meal
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2023.
- Derived from this study: PubMed 31564118Bruno JA, Feldman CH, Konas DW, Kerrihard AL, Matthews EL. Incorporating sprouted chickpea flour in pasta increases brachial artery flow-mediated dilation. Physiol Int. 2019 Sep 1;106(3):207-212. doi: 10.1556/2060.106.2019.21. Epub 2019 Sep 30.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Endothelial Dysfunction, run by Montclair State University.
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 1 inclusion and 6 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: finished, as of the sponsor's last update on 30 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-digestion flow mediated dilation (time frame: Two hours following meal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03801486, which also lists 1 linked publication.
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 30 Oct 2023; AzTrials last refreshed its copy on 8 Nov 2026.