A Single Group Study to Evaluate the Effects of a Multivitamin on a Range of Health and Wellbeing Outcomes.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Changes in Blood Levels of Vitamin B12
研究概览
简要总结
This is a hybrid single-group clinical trial that will last 12 weeks. Participants will take 2 capsules daily with the first meal of the day in the morning. Participants will undertake blood tests at Baseline and Week 12. Study-specific questionnaires will be completed at Baseline, Week 4, Week 8, and Week 12. Cognitive Battery Testing will take place at Baseline, Week 4, Week 8, and Week 12.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
盲法说明
This is an open-label study where no masking will be implemented.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female at birth.
- •Aged 18+.
- •Interested in supporting their health and wellbeing.
- •Not planning to introduce or change prescription medications, vitamins, minerals, or supplements one month prior to and during the study.
- •Generally healthy with no uncontrolled chronic conditions.
排除标准
- •Recent surgeries or invasive treatments.
- •Introduction of new health-related products in the last 12 weeks.
- •Allergies to product ingredients or use of Epi-Pen.
- •Chronic health conditions affecting participation.
- •Endocrine or glucose-related disorders, including diabetes.
- •Hematological disorders, including anemia.
- •Pregnant, breastfeeding, or planning to conceive.
- •History of substance abuse or recent smoking.
- •Unwillingness to follow the study protocol.
- •Participation in other clinical trials.
结局指标
主要结局
Changes in Blood Levels of Vitamin B12
时间窗: Baseline and Week 12
This outcome measure will assess the effect of the multivitamin supplement on serum levels of Vitamin B12.
Changes in Blood Levels of Insulin
时间窗: Baseline and Week 12
This outcome measure will assess the effect of the multivitamin supplement on serum levels of Insulin.
Changes in Blood Levels of Vitamin D
时间窗: Baseline and Week 12
This outcome measure will assess the effect of the multivitamin supplement on serum levels of Vitamin D.
Changes in Blood Levels of Iron
时间窗: Baseline and Week 12
This outcome measure will assess the effect of the multivitamin supplement on serum levels of Iron.
次要结局
- Participants' Perceptions of Health and Wellbeing(Baseline, Week 4, Week 8, and Week 12)