Safety and Efficacy of Two Qualia Iron Formulations on Iron Biomarkers and Quality of Life: A Randomized, Double-Blind Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Changes in iron status biomarkers
研究概览
简要总结
This randomized, double-blind parallel pilot study will evaluate the safety and efficacy of two Qualia Iron formulations versus placebo in approximately 40 healthy adults (aged 18+) over a 56-day period. Approximately 40 participants will be randomized to three study arms: Qualia Iron Version 1, 2, (n=15 each) or a Placebo (n=10). Each participant will take one or two capsules once daily in the morning, with or without food. The supplementation regimen is a 5 days on, 2 days off protocol, and goes for 56 days (8 weeks). The primary outcomes of this study are to assess between-group changes in iron status biomarkers. Secondary outcomes include within-group changes in iron status biomarkers, safety and tolerability as measured by a custom Safety and Tolerability survey, and RAND SF-36 quality of life scores.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provide voluntary, written, informed consent to participate in the study
- •Agree to provide a valid cell phone number and are willing to receive communications through text
- •Can read and write English
- •Willing to not begin taking any new supplements during the study and continue taking any supplements they are currently using regularly
- •Willing to complete questionnaires, records, and diaries associated with the study.
- •If the participant responded "Yes" to ≥2 questions on the custom Iron Inadequacy Questionnaire. Preference will be given to participants with a higher score.
- •If a participant has the following:
- •Ferritin 30 ng/mL (anything under 50 ng/mL is considered suboptimal, but participants with 30 ng/mL will be prioritized)
排除标准
- •Women who are pregnant, breastfeeding, or planning to become pregnant during the trial
- •Known food intolerances/allergy to any ingredients in the product
- •Having any of the following conditions: Psychiatric conditions, neurologic disorders, endocrine disorders, irritable bowel disease, cancer
- •Having had a significant cardiovascular event in the past 6 months
- •Taking MAO inhibitors, SSRIs, or any other psychiatric or neurological medicines
- •On immunosuppressive therapy
- •Individuals who were deemed incompatible with the test protocol
- •Adults lacking capacity to consent
- •Individuals taking any of the following medications:
- •Antacids Proton pump inhibitors (PPIs) Antipsychotics Antibiotics
研究组 & 干预措施
Qualia Iron Version A
Qualia Iron version A manufactured by Qualia Life Sciences
干预措施: Qualia Iron Version A (Dietary Supplement)
Qualia Iron Version B
Qualia Iron version B manufactured by Qualia Life Sciences
干预措施: Qualia Iron Version B (Dietary Supplement)
Placebo
Rice powder
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Changes in iron status biomarkers
时间窗: From 0-4 weeks, 4-8 weeks, and 0-8 weeks
Between-groups changes in ferritin levels (ng/mL) will be assessed.
次要结局
- Changes in CBC markers(From 0-4 weeks, 4-8 weeks, and 0-8 weeks)
- Changes in iron status biomarkers(From 0-4 weeks, 4-8 weeks and 0-8 weeks)
- Changes in Safety and Tolerability measured by Custom Survey(From 0-4 weeks, 4-8 weeks, and 0-8 weeks)
- Changes in RAND 36-Item Short Form Survey (SF-36)(From 0-4 weeks, 4-8 weeks, 0-8 weeks)
- Changes in inflammatory markers(From 0-4 weeks, 4-8 weeks, and 0-8 weeks)
- Changes in iron status biomarkers(From 0-4 weeks, 4-8 weeks, and 0-8 weeks)