- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07264465
A Clinical Trial to Evaluate the Effects of a Chickpea Pasta on Gut Health, Blood Glucose, and Overall Health
December 2, 2025 updated by: Banza LLC
This is a single-arm, 12-week pilot study evaluating the effects of a chickpea pasta on gut microbiome diversity, gastrointestinal health, and blood biomarkers.
The study will involve 12 participants consuming the test product five times per week, with questionnaires, microbiome testing, blood testing, and waist measurements collected at defined timepoints.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Nevada
-
Las Vegas, Nevada, United States, 89118
- Citruslabs
-
-
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
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Be male or female
- Be aged 21-44.
- Anyone currently experiencing issues regarding all of the following:
- Struggling to balance taste with health and convenience.
- Struggling to eat healthy due to a busy lifestyle.
- Self-reported poor gut health (including bloating, abdominal discomfort, and gas).
- Anyone who is generally healthy - does not live with any uncontrolled chronic disease.
- If taking oral over-the-counter supplements or herbal remedies targeted at gut health, blood sugar, and overall health and well-being, has been consistently taking these for at least 3 months prior to starting the study, and is willing to maintain this routine for the study duration.
- Not planning on introducing any products or any new forms of prescription medication or supplements that target gut health, blood sugar, or overall health and well-being for the study duration.
- Anyone willing to maintain their current diet, sleep pattern, and activity levels for the duration of the trial.
- Anyone who has tried pasta alternatives in the past (e.g., made of chickpeas, lentils, beans, etc.) or, if not, is open to trying them.
- Anyone with access to a 3-quart pasta pot that can be used 5 times weekly.
- Resides in the United States.
- Not currently partaking in another research study and will not be partaking in any other research study for the next 12 weeks and at any point during this study's duration.
Exclusion Criteria:
- Has been diagnosed with Type 1 or Type 2 diabetes.
- Anyone with pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders.
- Anyone with known severe allergic reactions.
- Anyone with any allergies or sensitivities to any of the study product ingredients.
- Any women who are pregnant, breastfeeding, or trying to conceive (or who will be at any point during the study period).
- Anyone unwilling to follow the study protocol.
- Anyone who has undergone any surgeries or invasive treatments in the last six months.
- Anyone planning to undergo any surgeries or invasive treatments during the study period.
- Anyone with a known history of severe digestive disorders like acid reflux, irritable bowel syndrome (IBS), irritable bowel disease (IBD), Crohn's disease, or gastrointestinal tract surgeries.
- Anyone with a history of substance abuse.
- Anyone who eats a pasta alternative (like chickpea pasta) one or more times per week.
- Follows a specific diet, such as ketogenic, paleo, or gluten-free
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
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Chickpea Pasta Intervention Arm
Participants will consume 1½ cups (188g) of cooked Banza chickpea pasta once daily, 5 days per week, for 12 weeks.
|
The intervention is intended to assess the effects of a high-fiber, legume-based dietary product on gut microbiome diversity, gastrointestinal function, and metabolic biomarkers.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in gut microbiome diversity
Time Frame: Baseline and Week 12
|
Gut microbiome diversity will be assessed using microbiome testing of stool samples.
This outcome will evaluate the effect of the intervention on microbial community richness and composition.
|
Baseline and Week 12
|
|
Change in gastrointestinal symptoms using the Gastrointestinal Symptom Rating Scale (GSRS)
Time Frame: Baseline, Week 4, Week 8, and Week 12
|
Assessed using the GSRS to evaluate symptoms such as bloating and abdominal discomfort.
|
Baseline, Week 4, Week 8, and Week 12
|
|
Change in blood biomarkers regarding Hemoglobin A1C
Time Frame: Baseline and Week 12
|
Measured via blood tests including Hemoglobin A1C with eAG.
|
Baseline and Week 12
|
|
Change in blood biomarkers regarding CMP-14
Time Frame: Baseline and Week 12
|
Measured via blood tests including CMP-14, lipid panel, and serum iron to assess metabolic and cardiovascular health indicators.
|
Baseline and Week 12
|
|
Change in stool quality using the Bristol Stool Scale (BSS)
Time Frame: Baseline, Week 4, Week 8, and Week 12
|
Assessed using the BSS to evaluate stool consistency and form.
|
Baseline, Week 4, Week 8, and Week 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Participant-reported perceptions of gut and overall health
Time Frame: Baseline, Week 4, Week 8, and Week 12
|
Evaluated through self-reported questionnaires on perceived gut health, weight management, bloating, confidence in clothes, and overall well-being.
|
Baseline, Week 4, Week 8, and Week 12
|
|
Change in waist circumference
Time Frame: Baseline, Week 4, Week 8, and Week 12
|
Participants will self-measure and report waist circumference to assess changes in central adiposity over the course of the intervention.
|
Baseline, Week 4, Week 8, and Week 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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)
February 20, 2025
Primary Completion (Actual)
July 30, 2025
Study Completion (Actual)
July 30, 2025
Study Registration Dates
First Submitted
September 30, 2025
First Submitted That Met QC Criteria
December 2, 2025
First Posted (Estimated)
December 4, 2025
Study Record Updates
Last Update Posted (Estimated)
December 4, 2025
Last Update Submitted That Met QC Criteria
December 2, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- 20724 (City of Hope Medical Center)
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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