NCT07756866已完成不适用
A Clinical Trial to Evaluate the Effects of Cowboy Colostrum on Gut Health, Body Composition, Hair Growth, and Skin Appearance
Cowboy Colostrum1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2025年7月7日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Change in Body Weight
研究概览
简要总结
This study evaluates the effects of Cowboy Colostrum bovine colostrum powder on gut health, body composition, hair growth, and skin appearance in generally healthy adults aged 21-47 with concerns in these areas. The trial is a single-arm, unblinded, virtual study conducted over 12 weeks in 35 participants who will use the test product daily.
Participants will complete questionnaires and provide weight and waist circumference measurements at Baseline, Week 4, Week 8, and Week 12. The primary focus is on changes in weight and waist circumference, while secondary outcomes include participants' perceptions of gastrointestinal health, physical activity, hair growth, skin appearance, and overall health and 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
- 21 Years 至 47 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be male or female
- •Be aged 21-47
- •Anyone with concerns regarding all of the following over the past four weeks: gut health, healthy weight management, hair growth, and skin appearance
- •BMI 25-33 kg/m²
- •Anyone who is generally healthy and does not live with any uncontrolled chronic disease
- •Anyone who is physically active at least once per week
- •If taking any products, herbal remedies, over-the-counter medications, or supplements that target weight, gut health, physical activity, hair growth, or skin appearance, has been doing so consistently for three months and is willing to maintain this routine for the study duration
- •Willing to maintain their current diet and sleep schedule for the duration of the study
- •Willing to use the same skincare routine and make-up products for at least one month prior to the study, and willing to maintain this routine for the duration of the study
- •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 oncological and psychiatric disorders
- •Anyone who has undergone any surgeries or invasive treatments in the last six months, or has any planned during the study period
- •Has had any major illness in the last three months
- •Anyone who has taken an antibiotic in the last three months
- •Anyone currently taking a weight loss medication, including but not limited to Wegovy, Mounjaro, and Ozempic
- •History of an autoimmune disorder, diabetes, or endocrine disorder
- •Food intolerances, allergies, or sensitivities such as dairy allergy and lactose intolerance
- •Has 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 diagnosed with a skin or hair condition
- •Anyone who does not consume animal products for any reason
- •Currently undergoing hair treatment or using other hair growth/thickening products
- •Currently taking any prescription medication for hair loss
- •Anyone with any conditions that affect the hair or scalp (e.g., alopecia areata)
- •Anyone planning to undergo facial treatments during the study period, including Botox, dermal fillers, and chemical peels
- •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)
- •Heavy drinkers, defined as a woman who drinks 8 or more alcoholic drinks per week or a man who drinks 15 or more alcoholic drinks per week
- •Anyone unwilling to follow the study protocol
- •Anyone with a history of substance abuse
- •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 for the next 12 weeks or at any point during this study's duration
研究组 & 干预措施
Cowboy Colostrum
Experimental
干预措施: Cowboy Colostrum (Dietary Supplement)
结局指标
主要结局
Change in Body Weight
时间窗: Baseline, Week 4, Week 8, and Week 12
Self-reported body weight measured daily for three consecutive days at each time point using a Withings smart scale; the average of the two closest values is used
Change in Waist Circumference
时间窗: Baseline, Week 4, Week 8, and Week 12
Self-reported waist circumference measured using a tape measure
次要结局
- Change in Gastrointestinal Symptoms(Baseline, Week 4, Week 8, and Week 12)
- Change in Digestion-associated Quality of Life(Baseline, Week 4, Week 8, and Week 12)
- Change in Physical Activity(Baseline, Week 4, Week 8, and Week 12)
- Participants' Perception of Bloating(Baseline, Week 4, Week 8, and Week 12)
- Participants' Perception of Bowel Movement Frequency(Baseline, Week 4, Week 8, and Week 12)
- Participants' Perception of Digestion(Baseline, Week 4, Week 8, and Week 12)
- Participants' Perception of Healthy Weight Management(Baseline, Week 4, Week 8, and Week 12)
- Participants' Perception of Energy Levels(Baseline, Week 4, Week 8, and Week 12)
- Participants' Perception of Hair Growth(Baseline, Week 4, Week 8, and Week 12)
- Participants' Perception of Hair Texture(Baseline, Week 4, Week 8, and Week 12)
- Participants' Perception of Skin Brightness(Baseline, Week 4, Week 8, and Week 12)
- Participants' Perception of Skin Clearness(Baseline, Week 4, Week 8, and Week 12)
- Participants' Perception of Product Efficacy(Baseline, Week 4, Week 8, and Week 12)
研究者
研究点 (1)
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