- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03801486
Effects of Incorporating Sprouted and Non-sprouted Chickpea Flour in Pasta Products Analyzed in Vivo Flow-mediated Dilation
October 27, 2023 updated by: Montclair State University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
34
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
Healthy adults
Description
Inclusion Criteria:
- healthy adult
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
255g of pasta with 40% sprouted chickpea flour and 60% semolina flour (SCF40) with butter.
Other Names:
|
Control (SEM100)
At the control data collection visits participants consumed 255g of pasta made with 100% semolina flour (SEM100) with butter.
|
255g of pasta with 100% semolina flour (SEM100) with butter.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Post-digestion flow mediated dilation
Time Frame: Two hours following meal
|
Post meal
|
Two hours following meal
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 2, 2016
Primary Completion (Actual)
May 1, 2017
Study Completion (Actual)
May 1, 2017
Study Registration Dates
First Submitted
January 9, 2019
First Submitted That Met QC Criteria
January 9, 2019
First Posted (Actual)
January 11, 2019
Study Record Updates
Last Update Posted (Actual)
October 30, 2023
Last Update Submitted That Met QC Criteria
October 27, 2023
Last Verified
January 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15-16-133
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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