A Clinical Trial to Evaluate the Effects of a Supplement on Supporting Signs of a Healthy Metabolism
This study evaluates the effects of Love Wellness Energize, a dietary supplement, on supporting signs of a healthy metabolism in women aged 25-45 who report poor energy levels, perception of poor metabolism, difficulty with weight management, and feeling bloated. The trial is a single-arm, open-label, virtual study conducted over 4 weeks with 40 female participants.
Participants will dissolve one tablet of the test product in 16 fl.oz/475 mL of water twice daily and complete self-reported questionnaires at Baseline, Week 1, Week 2, Week 3, and Week 4. The primary endpoint is change in metabolism support, and secondary endpoints include perceptions of energy, bloating after hydration, and weight management support.
研究概览
地位
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
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Nevada
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Las Vegas、Nevada、美国、89101
- Citruslabs
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参与标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
描述
Inclusion Criteria:
- Be female.
- Be aged 25-45.
- Currently experiencing issues regarding all of the following: poor energy levels, perception of poor metabolism, difficulty with weight management, and feeling bloated.
- 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 study duration.
- Resides in the United States.
Exclusion Criteria:
- 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 diagnosed with and getting treated for Parkinson's disease.
- Anyone taking a prescription diabetes medication including but not limited to GLP-1 receptor agonist medications such as Ozempic, Wegovy, or Mounjaro.
- 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 testing or planning to test, in the next 4 weeks, a product for another research study.
- Anyone unwilling to follow the study protocol.
- Anyone with any allergies or sensitivities to any of the study product ingredients.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Love Wellness Energize
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All participants dissolve one tablet of Love Wellness Energize in 16 fl.oz/475
mL of water twice daily at 11 am and 3 pm (or after planned exercise) for 4 weeks.
Ingredients include Vitamin B1 15 mg, Vitamin B3 30 mg, Vitamin B6 10 mg, Vitamin B12 250 mcg, Calcium 100 mg, Magnesium 60 mg, Chromium 200 mcg, Sodium 310 mg, and Potassium 200 mg, among other excipients.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Healthy Metabolism Support
大体时间:Baseline, Week 1, Week 2, Week 3, and Week 4
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Self-reported perception of metabolism support, assessed via self-reported questionnaire
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Baseline, Week 1, Week 2, Week 3, and Week 4
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Self-Reported Energy
大体时间:Baseline, Week 1, Week 2, Week 3, and Week 4
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Participants' perceived effects of the test product on energy levels, assessed via self-reported questionnaire
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Baseline, Week 1, Week 2, Week 3, and Week 4
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Change in Self-Reported Bloating After Hydration
大体时间:Baseline, Week 1, Week 2, Week 3, and Week 4
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Participants' perceived effects of the test product on bloating after hydration, assessed via self-reported questionnaire
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Baseline, Week 1, Week 2, Week 3, and Week 4
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Change in Self-Reported Weight Management Support
大体时间:Baseline, Week 1, Week 2, Week 3, and Week 4
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Participants' perceived effects of the test product on weight management support, assessed via self-reported questionnaire
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Baseline, Week 1, Week 2, Week 3, and Week 4
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合作者和调查者
合作者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 20746
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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