A Clinical Trial to Evaluate the Effects of A Supplement on Supporting Signs of Metabolic Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in Perceived Metabolic Health
研究概览
简要总结
This study evaluates the effects of the Love Wellness supplement Hello Burn Activate on supporting metabolic health in adult females. The 12-week, single-arm, open-label, virtual trial will enroll 40 female participants aged 25-45 who are experiencing challenges with healthy weight management and body confidence.
All participants will take one capsule of the test product daily in the morning with their first meal. Participants will complete self-reported questionnaires at Baseline, Week 4, Week 8, and Week 12 to assess changes in perceived metabolic health, body confidence, 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
- 25 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be female.
- •Be aged 25-
- •Currently experiencing issues regarding healthy weight management.
- •Currently experiencing issues regarding body confidence.
- •Currently experiencing difficulty maintaining a weight management routine.
- •Generally healthy - does not live with any uncontrolled chronic disease.
- •Willing to refrain from taking any products, prescription medications, or supplements that target metabolic health during the test period.
- •Willing to maintain their current diet, sleep schedule, and activity level 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 cancer, mental health disorders, history of serious illness in the last three months, history of substance abuse, or planned surgery during the study period.
- •Anyone taking a prescription GLP-1 medication, including but not limited to Ozempic, Wegovy, or Mounjaro.
- •Anyone taking a prescription anticoagulant ('blood thinner') medication.
- •Anyone taking a prescription antibiotic.
- •Anyone who drinks heavily (i.e., 8 or more alcoholic drinks per week for women or 15 or more alcoholic drinks per week for men).
- •Any women who are pregnant, breastfeeding, or trying to conceive (or who will be at any point during the study period).
- •Anyone participating in another research study within the next 12 weeks.
- •Anyone unwilling to follow the study protocol.
- •Anyone with any allergies or sensitivities to any of the study product ingredients.
研究组 & 干预措施
Hello Burn Activate
干预措施: Hello Burn Activate (Dietary Supplement)
结局指标
主要结局
Change in Perceived Metabolic Health
时间窗: Baseline, Week 4, Week 8, and Week 12
Self-reported assessment of overall metabolic health via self-reported questionnaire
次要结局
- Change in Body Confidence(Baseline, Week 4, Week 8, and Week 12)
- Change in Overall Well-Being(Baseline, Week 4, Week 8, and Week 12)
- Change in Overall Health(Baseline, Week 4, Week 8, and Week 12)