A Clinical Trial to Evaluate the Effects of a Chickpea Pasta on Gut Health, Blood Glucose, and Overall Health
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Banza LLC
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Change in gastrointestinal symptoms using the Gastrointestinal Symptom Rating Scale (GSRS)
Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 44 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Be male or female
- •Be aged 21-
- •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.
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.
Outcomes
Primary Outcomes
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.
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.
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.
Change in blood biomarkers regarding Hemoglobin A1C
Time Frame: Baseline and Week 12
Measured via blood tests including Hemoglobin A1C with eAG.
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.
Secondary Outcomes
- Participant-reported perceptions of gut and overall health(Baseline, Week 4, Week 8, and Week 12)
- Change in waist circumference(Baseline, Week 4, Week 8, and Week 12)