NCT03801486

Brief 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2016

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 2, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

January 9, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 11, 2019

Completed
Last Updated

October 30, 2023

Status Verified

January 1, 2019

Enrollment Period

1.2 years

First QC Date

January 9, 2019

Last Update Submit

October 27, 2023

Conditions

Endothelial Dysfunction

Outcome Measures

Primary Outcomes (1)

  • Post-digestion flow mediated dilation

    Post meal

    Two hours following meal

Study Arms (2)

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.

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.

Other: Control: Semolina Flour

Interventions

Experimental: Sprouted Chickpea FlourOTHER

255g of pasta with 40% sprouted chickpea flour and 60% semolina flour (SCF40) with butter.

Also known as: SCF40
Experimental (SCF40)
Control: Semolina FlourOTHER

255g of pasta with 100% semolina flour (SEM100) with butter.

Also known as: SEM100
Control (SEM100)

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Healthy adults

You may qualify if:

  • healthy adult

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 31564118DERIVED

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2019

First Posted

January 11, 2019

Study Start

March 2, 2016

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

October 30, 2023

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share