An Exploratory Investigation of a Supplement to Promote Gut Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in overall well-being [Time Frame: Baseline to Week 12]
研究概览
简要总结
Bovine colostrum is a dairy food and the first milk produced by the mother cow. Abundant research exists revealing the valuable health benefits it confers due to its unique nutritional properties., including benefits to gastrointestinal health, fitness, and overall well-being.This study aims to test a specific food-grade supplement, ARMRA Colostrum Immune Revival, over a 12-week trial to better understand the well-being, fitness, and gut benefits. This trial will use two groups, one that suffers from gastrointestinal complaints frequently and another that exercises at least three days a week.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or Female between 18-65 years of age.
- •Self-reported digestive issues (abdominal pain, gas production, bloating after meals, or heartburn after meals) (GUT HEALTH GROUP ONLY)
- •Must be physically active three or more days a week and willing to maintain their current activity level (PERFORMANCE GROUP ONLY)
- •Must be willing to refrain from lifestyle changes affecting their gastrointestinal tract.
- •Must be in good health with no significant chronic conditions.
- •Following a stable, consistent diet regimen.
- •Have a reliable way to measure their weight.
排除标准
- •Females who are pregnant or breastfeeding
- •Suffers from pre-existing conditions that would prevent them from adhering to the protocol.
- •Has a lactose allergy or intolerance.
- •Serious food allergies
研究组 & 干预措施
Gut Health Group
Subjects with self-reported digestive issues (abdominal pain, gas production, bloating after meals, or heartburn after meals) Dose: two sachets daily (1g each) mixed with a cold drink, for 12 weeks.
干预措施: ARMRA™ Bovine Colostrum (Drug)
Exercise Performance Group
Subjects that are physically active three or more days a week. Dose: two sachets daily (1g each) mixed with a cold drink, for 12 weeks.
干预措施: ARMRA™ Bovine Colostrum (Drug)
结局指标
主要结局
Change in overall well-being [Time Frame: Baseline to Week 12]
时间窗: 12 weeks
Well-being will be measured via study-specific surveys. Data was collected using a textual 5 or 6-point Likert scale for each question, such as "Not noticeable" to "severe." Symptom-related questions were conducted at baseline and each check-in. The textual Likert data was transformed into numerical values of 1-6, with 1 representing the least favorable/worse outcome ("severe" response to the question, "how severe would you rate your stress"), and 6 representing the most beneficial response (i.e., "no symptoms" to the question, "how severe would you rate your stress").
Change in hs-CRP [Time Frame: Baseline to Week 12]
时间窗: 12 weeks
Biomarker assessment will be completed to assess changes in hs-CRP. Participants will complete a finger-prick dried blood spot test, at Baseline and Week 12.
次要结局
- Change in self-reported gastrointestinal outcomes, such as bloating, heartburn, irregular bowel movements, and gas [Time Frame: Baseline to Week 12](12 weeks)
- Change in recovery and fitness levels [Time Frame: Baseline to Week 12](12 weeks)