A Clinical Trial to Evaluate the Effects of a Supplement on Symptoms Associated With Liver and Digestive Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in Alanine Aminotransferase (ALT/SGPT)
研究概览
简要总结
This study will evaluate the effects of Edenboost Alpha Cleanse, a dietary supplement, on symptoms associated with liver and digestive health. The study is a single-arm, open-label trial in which all 40 enrolled participants will use the test product daily for 12 weeks.
Participants will complete questionnaires at Baseline, Week 4, Week 8, and Week 12, and will undergo blood testing (hepatic function panel) at Baseline and Week 12. Primary outcomes focus on changes in liver function biomarkers, while secondary outcomes capture participants' self-reported experiences of energy levels, abdominal bloating, abdominal pain, fatigue, and nausea.
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
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be male or female.
- •Be aged 40-
- •Anyone who has struggled with low energy levels and fatigue over the past four weeks.
- •Anyone who has struggled with at least two of the following symptoms over the past four weeks: abdominal bloating, abdominal discomfort, constipation, diarrhea, digestive discomfort.
- •Willing to maintain the same diet, sleep pattern, and exercise regimen consistently throughout the study duration.
- •If taking any other supplements, medications, or herbal remedies, has been doing so consistently for at least three months and is willing to maintain this routine for the duration of the trial.
- •Willing to avoid introducing any other supplements, medications, or herbal remedies for the duration of the trial.
- •Resides in the United States.
排除标准
- •Anyone with pre-existing chronic conditions that would prevent participants from adhering to the protocol, including mental health disorders, a history of serious illness in the last three months, a history of substance abuse, or planned surgery during the study period.
- •Anyone with a known history of severe digestive disorders like acid reflux, peptic ulcers, Irritable Bowel Syndrome (IBS), Irritable Bowel Disease (IBD), GI bleeding, Crohn's disease, Ulcerative Colitis (UC), or gastrointestinal tract surgeries.
- •Anyone with a history of kidney stones.
- •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 on Coumadin (warfarin) or antiplatelet therapy (e.g., Plavix (clopidogrel), aspirin).
- •Anyone with uncontrolled chronic disease, including but not limited to diabetes, hypertension (high blood pressure), and thyroid-related conditions.
- •Anyone unwilling to follow the study protocol.
- •Anyone who is currently a smoker or has been a smoker in the past 3 months.
- •Currently partaking in another research study or will be partaking in any other research study at any point during this study's duration.
结局指标
主要结局
Change in Alanine Aminotransferase (ALT/SGPT)
时间窗: Baseline and Week 12
Change in serum ALT/SGPT level assessed via hepatic function panel blood test at Labcorp
Change in Albumin
时间窗: Baseline and Week 12
Change in serum albumin level assessed via hepatic function panel blood test at Labcorp
Change in Alkaline Phosphatase
时间窗: Baseline and Week 12
Change in serum alkaline phosphatase level assessed via hepatic function panel blood test at Labcorp
Change in Aspartate Aminotransferase (AST/SGOT)
时间窗: Baseline and Week 12
Change in serum AST/SGOT level assessed via hepatic function panel blood test at Labcorp
Change in Bilirubin
时间窗: Baseline and Week 12
Change in serum bilirubin level assessed via hepatic function panel blood test at Labcorp
Change in Total Protein
时间窗: Baseline and Week 12
Change in serum total protein level assessed via hepatic function panel blood test at Labcorp
次要结局
- Change in Self-Reported Abdominal Bloating(Baseline, Week 4, Week 8, and Week 12)
- Change in Self-Reported Abdominal Pain(Baseline, Week 4, Week 8, and Week 12)
- Change in Self-Reported Fatigue(Baseline, Week 4, Week 8, and Week 12)
- Change in Self-Reported Nausea(Baseline, Week 4, Week 8, and Week 12)
- Change in Self-Reported Energy Levels(Baseline, Week 4, Week 8, and Week 12)