A Clinical Trial to Evaluate the Effects of a Plant-Based Liquid Supplement on Metabolic Health and Overall Well-Being
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in Body Weight
研究概览
简要总结
This single-arm clinical trial will evaluate the effects of a plant-based liquid supplement on metabolic health, digestive health, skin health, and overall well-being. Twenty participants aged 40 to 60 years with elevated alanine transaminase (ALT) or aspartate transaminase (AST) levels will use the supplement daily for 90 days. Participants will complete questionnaires, provide body composition and waist circumference measurements, submit photographs, and undergo blood testing throughout the study. Outcomes include changes in metabolic biomarkers, body composition, digestive symptoms, skin health, and overall well-being.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 40 to 60 years
- •Elevated ALT or AST identified during prescreening blood testing
- •Currently experiencing at least two of the following:
- •Stomach discomfort, Constipation, Diarrhea, Heartburn, Bloating, Gas, Abdominal pain, Skin redness or pimples, Sugar cravings
- •Willing to comply with study requirements
- •Willing to discontinue supplements or herbal remedies targeting detoxification, digestive health, liver function, or skin health during the study
- •Willing to avoid starting new products, medications, or supplements targeting detoxification, digestive health, liver function, or skin health
- •Willing to maintain normal diet, sleep patterns, and activity levels
- •Generally healthy without uncontrolled chronic disease
- •Resides in the United States
- •Not participating in another research study during the study period
- •Has access to a study partner to take study photographs
排除标准
- •Severe digestive disorders including acid reflux, IBS, IBD, Crohn's disease, or gastrointestinal tract surgeries
- •Liver disease
- •Known allergy or hypersensitivity to study product ingredients Chronic conditions that would interfere with study participation, including oncological or psychiatric disorders
- •Known severe allergic reactions
- •Pregnant, breastfeeding, or attempting to conceive
- •Unwilling to follow study procedures
- •Stopped hormonal birth control within the past month
- •History of substance abuse
- •Use of prescription diabetes medications, including GLP-1 receptor agonists such as Ozempic, Wegovy, or Mounjaro
研究组 & 干预措施
Plant-Based Liquid Supplement
Participants will consume one ampule of the study product diluted in approximately 8 ounces of water before the first meal of the day throughout the study period.
干预措施: Plant-Based Liquid Supplement (Dietary Supplement)
结局指标
主要结局
Change in Body Weight
时间窗: Baseline, Day 30, Day 60, and Day 90.
Change in body weight measured using a Withings smart scale.
Change in Waist Circumference
时间窗: Baseline, Day 7, Day 30, Day 60, and Day 90.
Change in waist circumference measured using a tape measure and recorded in centimeters.
Change in Body Fat Mass
时间窗: Baseline, Day 7, Day 30, Day 60, and Day 90.
Change in body fat mass measured using a Withings smart scale.
Change in Lean Body Mass
时间窗: Baseline, Day 7, Day 30, Day 60, and Day 90.
Change in lean body mass measured using a Withings smart scale.
Change in Visceral Fat Index
时间窗: Baseline, Day 7, Day 30, Day 60, and Day 90.
Change in visceral fat index measured using a Withings smart scale.
Change in Alanine Aminotransferase (ALT)
时间窗: Baseline, Day 30, Day 60, and Day 90.
Change in serum alanine aminotransferase concentration measured by hepatic function panel.
Change in Aspartate Aminotransferase (AST)
时间窗: Baseline, Day 30, Day 60, and Day 90
Change in serum aspartate aminotransferase concentration measured by hepatic function panel.
Change in Alkaline Phosphatase (ALP)
时间窗: Baseline, Day 30, Day 60, and Day 90.
Change in serum alkaline phosphatase concentration measured by hepatic function panel.
Change in Total Bilirubin
时间窗: Baseline, Day 30, Day 60, and Day 90.
Change in serum total bilirubin concentration measured by hepatic function panel.
Change in Total Cholesterol
时间窗: Baseline, Day 30, Day 60, and Day 90.
Change in serum total cholesterol concentration measured by lipid panel.
次要结局
- Change in Participant-Reported Bloating Severity(Baseline, Day 1, Day 3, Day 7, Day 30, Day 60, and Day 90.)
- Change in Participant-Reported Flatulence Severity(Baseline, Day 1, Day 3, Day 7, Day 30, Day 60, and Day 90.)
- Change in Participant-Reported Heartburn Severity(Baseline, Day 1, Day 3, Day 7, Day 30, Day 60, and Day 90.)
- Change in Participant-Reported Digestive Comfort(Baseline, Day 1, Day 3, Day 7, Day 30, Day 60, and Day 90.)
- Change in Participant-Reported Skin Health(Baseline, Day 1, Day 3, Day 7, Day 30, Day 60, and Day 90.)