A Clinical Trial to Evaluate the Effects of a Supplement on Symptoms Associated With Hormone Imbalance
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 Symptoms Associated with Hormone Imbalance
研究概览
简要总结
This study evaluates the effects of the Love Wellness Hello Burn, Balance supplement on symptoms associated with hormone imbalance, as measured by energy levels and healthy eating choices and habits. The trial is a single-arm, open-label, virtual study conducted over 4 weeks, in which all 40 enrolled participants will take the test product daily.
Participants will complete self-reported questionnaires at Baseline, after First Use (within 1-3 hours of use), and at Weeks 1, 2, 3, and 4 to assess changes in symptoms associated with hormonal imbalance, energy levels, healthy eating choices and habits, metabolism, and overall product efficacy.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be female
- •Be aged 25 or over
- •Has in the past 4 weeks experienced issues regarding all of the following: difficulty making healthy eating choices and habits, hormonal-driven challenges with healthy eating choices and habits, self-perceived slow metabolism, and low energy
- •Generally healthy - does not live with any uncontrolled chronic disease
- •If taking oral over-the-counter supplements or herbal remedies targeted at hormone balance or energy, has been consistently taking these for at least 3 months prior to starting the study and is willing to maintain this routine for the study duration
- •Willing to refrain from introducing any products or any new forms of prescription medication or supplements that target hormone balance or energy for the study duration
- •Willing to maintain their diet, sleep schedule, and activity level for the duration of the study
- •Not currently partaking in another research study and will not be partaking in any other research study for the next 4 weeks and at any point during this study's duration
- •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 currently taking a prescription thyroid treatment (like levothyroxine)
- •Anyone with known severe allergic reactions
- •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 diagnosed with diabetes (type I or type II)
- •Anyone unwilling to follow the study protocol
- •Has changed birth control in the past 3 months
- •Anyone planning to undergo any surgeries or invasive treatments during the study duration
- •Anyone who has had any major illness in the last 3 months
- •Anyone with a history of substance abuse
研究组 & 干预措施
Hello Burn, Balance Supplement
干预措施: Hello Burn, Balance Supplement (Dietary Supplement)
结局指标
主要结局
Change in Symptoms Associated with Hormone Imbalance
时间窗: Baseline, First Use (within 1-3 hours of use), Week 1, Week 2, Week 3, and Week 4
Assessed via self-reported questionnaire measuring participant-perceived symptoms associated with hormonal imbalance
次要结局
- Change in Energy Levels(Baseline, First Use (within 1-3 hours of use), Week 1, Week 2, Week 3, and Week 4)
- Change in Healthy Eating Choices(Baseline, First Use (within 1-3 hours of use), Week 1, Week 2, Week 3, and Week 4)
- Change in Perception of Metabolism(Baseline, First Use (within 1-3 hours of use), Week 1, Week 2, Week 3, and Week 4)
- Product Efficacy Perception(Baseline, First Use (within 1-3 hours of use), Week 1, Week 2, Week 3, and Week 4)