Radicle Recharge™: A Randomized, Double-blind, Placebo-controlled Trial Assessing the Immediate Effects of Non-caffeinated Supplements on Energy Levels and Associated Health Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 264
- 试验地点
- 1
- 主要终点
- Change in energy
研究概览
简要总结
A randomized, double blind, placebo-controlled trial assessing the immediate impact of non-caffeinated supplements on energy levels and associated health outcomes
详细描述
This is a randomized, double blind. placebo-controlled study conducted with adult participants (study volunteers, citizen scientists), at least 21 years of age at the time of consent and attending the Supply Side West Meeting (SSW) this year.
Eligible participants will (1) endorse a desire for more energy and (2) express acceptance in taking a product and not knowing its formulation until the end of the study.
Participants that report a known contraindication or with well-established, significant safety concerns due to illness and/or medication(s) will be excluded. Participants that report a known allergy to any possible ingredient they may be exposed to in one of the study arms will be excluded.
Participants will take their assigned study product at a Radicle booth, after enrolling.
Participant reported outcomes (PROs) are collected electronically from eligible participants at baseline (before study product consumption, and for a period of 5 hours after consuming their study product.
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
- Double (Participant, Investigator)
盲法说明
The investigator is blinded to the participants assigned study products. Participants are blinded to the study product they received.
入排标准
- 年龄范围
- 21 Years 至 105 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults at least 21 years of age at the time of electronic consent, inclusive of all ethnicities, races, sexes, and gender identities
- •Attending the Supply Side West meeting in person
- •Able to read and understand English
- •Endorses more energy as a primary desire
- •Expresses a willingness to take a study product and not know the product identity (active or placebo) until the end of the study
排除标准
- •Reports being pregnant, trying to become pregnant, or breastfeeding
- •Reports current enrollment in another clinical trial
- •Reports a cardiac disease that presents an absolute contraindication and/or a significant safety concern with any of the study product ingredients.
- •Reports taking medications that have a well-established moderate or severe interaction, posing a substantial safety risk with any of the study products ingredients: Anticoagulants, chemotherapy, immunotherapy, medications that warn against grapefruit consumption, oral diabetic medications, or oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection
- •Reports an allergy to any of the study products ingredients
研究组 & 干预措施
Active Product 1
Recharge Product Form 2 - active product 1
干预措施: Recharge Active Study Product 1 (Dietary Supplement)
Placebo Control 1
Recharge Product Form 1 - control
干预措施: Recharge Placebo Control 1 (Dietary Supplement)
Active Product 2
Recharge Product Form 3 - active product 1
干预措施: Recharge Active Study Product 2 (Dietary Supplement)
Active Product 3
Recharge Product Form 4 - active product 1
干预措施: Recharge Active Study Product 3 (Dietary Supplement)
结局指标
主要结局
Change in energy
时间窗: 5 hours
Mean difference in energy score as assessed by Energy Visual Analog Scale (VAS) (scale 0 - 10; where 0 is no energy and 10 is more than enough energy)
次要结局
- Minimal clinically important difference (MCID) in fatigue(5 hours)
- Change in cognitive function(5 hours)
- Minimal clinically important difference (MCID) in energy(5 hours)
- Change in fatigue(5 hours)
- Minimal clinically important difference (MCID) in cognitive function(5 hours)