A Clinical Trial to Evaluate the Effects of a Chickpea Pasta on Gut Health, Blood Glucose, and Overall Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Change in gastrointestinal symptoms using the Gastrointestinal Symptom Rating Scale (GSRS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 44 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
- •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.
排除标准
- •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
结局指标
主要结局
Change in gastrointestinal symptoms using the Gastrointestinal Symptom Rating Scale (GSRS)
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: Baseline and Week 12
Measured via blood tests including Hemoglobin A1C with eAG.
Change in stool quality using the Bristol Stool Scale (BSS)
时间窗: Baseline, Week 4, Week 8, and Week 12
Assessed using the BSS to evaluate stool consistency and form.
次要结局
- 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)