A Clinical Trial to Evaluate the Effects of a Chickpea Pa... | NCT07264465

NCT07264465

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
Citruslabs	INDUSTRY

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Chickpea Pasta Intervention Arm	Experimental	Participants will consume 1½ cups (188g) of cooked Banza chickpea pasta once daily, 5 days per week, for 12 weeks.	Dietary Supplement: Chickpea Pasta

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Chickpea Pasta	Dietary Supplement	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in gut microbiome diversity	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)	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	Measured via blood tests including Hemoglobin A1C with eAG.	Baseline and Week 12
Change in blood biomarkers regarding CMP-14	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)	Assessed using the BSS to evaluate stool consistency and form.	Baseline, Week 4, Week 8, and Week 12

Secondary Outcomes

Measure	Description	Time Frame
Participant-reported perceptions of gut and overall health	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

Eligibility Module

Eligibility Criteria

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