Birth Control Supplement Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Change From Baseline in Levels of Perceived Vulnerability to Disease Scale After 1 Month of Drug Usage
研究概览
简要总结
The goal of this clinical trial is to learn if the Alii Supplement can be used to reduce symptoms related to nutritional depletion in hormonal birth control pill users. The main questions it aims to answer are:
Does usage of the supplement increase happiness, decrease perceived vulnerability to disease, increase digestive health, decrease mood swings, and increase energy?
The investigators will compare the Alii Supplement to a placebo (a capsule that contains no drug) to see if the Alii Supplement works to reduce symptoms associated with nutritional depletion.
Participants will:
Take the placebo or Alii Supplement everyday for 28 days and visit the research office twice to fill out an online survey comprising of items examining the main outcome measures.
详细描述
This randomized, double-blind clinical trial will look to examine the efficacy of the Alii supplement, compared to a placebo, on reducing symptoms related to nutritional depletion in hormonal birth control pill users. This clinical trial will be conducted on 68 female university students. Participants will fill out measures of happiness, mood swings, digestive health, vulnerability to disease, and energy at time 1. Participants will then be randomly assigned to take a placebo or the Alii supplement for 28 days. Specifically, participants will take three capsules per day, with or without food. Participants will receive daily reminders to take their capsules. After taking the placebo or the supplement for 28 days, participants will again fill out the same measures of happiness, mood swings, digestive health, vulnerability to disease, and energy. Differences in these outcomes over time will be assessed to determine if taking the Alii supplement can improve these outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None (Participant, Investigator)
盲法说明
Originally, participants were going to receive the supplement or a placebo. Due to recruitment and timing restrictions, all participants received the supplement. Only the primary investigator and co-investigator had knowledge as to what group each participant is in. The research assistants who were the only individuals interacting with the participants did not know if the participants received a placebo or the supplement. Moreover, participants did not know if they received a placebo or the supplement.
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participants must be on the hormonal birth control pill as the investigators are testing the effectiveness of a supplement for women who take the hormonal birth control pill
- •Participants must be willing to complete a follow up survey as this study will be multiple parts
- •Participants must be willing to take a daily supplement as this study is testing how a supplement influences a variety of psychological outcomes
- •Participants must be on the hormonal birth control pill for at least six months as participants who have been on the pill for less than 6 months may not be experiencing nutritional depletion yet
- •If the investigators are able to do so, the investigators will only recruit participants who take the one-month hormonal birth control pill rather than the three month hormonal birth control pill, as the investigators are going to have participants come in after 28 days (day 2 of pack 1 and day 2 of pack 2) and participants on the three-month HBC pill may be on a 21 day cycle.
- •Participants must have no food or medication allergies that will prevent the participants from safely taking the supplement
- •Participants must not be taking any vitamins or participant must report willingness to abstain from taking vitamins during the study as individuals who are already taking vitamins may not be experiencing nutritional depletion associated with hormonal birth control
- •If the investigators have the ability to do so, the investigators will only recruit participants who are not taking medications. Participants on various medications (e.g., SSRIs, ADHD medications, etc.) may report differing psychological states due to their medications, rather than the supplement. Therefore, it would be best to exclude those individuals if possible.
排除标准
- •Participants cannot be naturally cycling as the investigators are testing a supplement for women on hormonal birth control
- •Participants cannot be unwilling to complete a follow up study because this is a multi-part study
- •Participants cannot be unwilling to take a supplement because the study centers around taking a supplement
- •Participants cannot be on the hormonal birth control pill for less than 6 months as participants who have been on the pill for less than 6 months may not be experiencing nutritional depletion yet
- •If the investigators are able to do so, participants cannot take the three month hormonal birth control pill, as the investigators are going to have participants come in after 28 days (day 2 of pack 1 and day 2 of pack 2) and participants on the three-month HBC pill may be on a 21 day cycle.
- •Participants cannot have any food or medication allergies that will prevent the participants from safely taking the supplement
- •Participants must not be taking any vitamins or participants must report willingness to abstain from taking vitamins during the study as individuals who are already taking vitamins may not be experiencing nutritional depletion associated with hormonal birth control
- •If the investigators have the ability to do so, the investigators will only recruit participants who are not taking medications. Participants on various medications (e.g., SSRIs, ADHD medications, etc.) may report differing psychological states due to their medications, rather than the supplement. Therefore, it would be best to exclude those individuals if possible.
研究组 & 干预措施
Alii Supplement
Participants will be assigned by researchers to take the Alii Supplement. The investigators who are giving the participant the Alii supplement will not know if the participants are receiving a placebo or the supplement. Participants will take 3 pills per day for 28 days.
干预措施: Alii Supplement (Dietary Supplement)
结局指标
主要结局
Change From Baseline in Levels of Perceived Vulnerability to Disease Scale After 1 Month of Drug Usage
时间窗: From day 1 of supplement usage to the end of treatment at 4 weeks.
Participants completed the Perceived Infectability Subscale of the Perceived Vulnerability to Disease Scale. For each scale item, 1 = Strongly disagree to 7 = Strongly agree. The subscale scores can range from 1 to 7. Higher scores indicate a higher perceived vulnerability to disease. Higher scores indicate a worse outcome. Subscale items were averaged together to create a perceived infectability score.
Change From Baseline in Levels of Happiness After 1 Month of Drug Usage
时间窗: From day 1 of supplement usage to the end of treatment at 4 weeks.
Participants complete the Short Depression-Happiness Scale. For each scale item, 1 = Never... 4 = Often. Higher scores indicate higher levels of happiness. Higher scores indicate a better outcome. Happiness scores can range from 1 to 4. Scores for happiness level were created by taking the mean of all scale items.
Change From Baseline in Levels of Digestive Health After 1 Month of Drug Usage
时间窗: From day 1 of supplement usage to the end of treatment at 4 weeks.
Participants complete a modified version of the Birmingham IBS Symptom Questionnaire. For each scale item, 1: All of the time... 6: None of the time. Higher scores indicate better digestive health. Higher scores indicate a better outcome. Scores could range from 1 to 6. Scores for digestive health were calculated by taking the mean of all the scale items.
Change From Baseline in Levels of Mood Swings After 1 Month of Drug Usage
时间窗: From day 1 of supplement usage to the end of treatment at 4 weeks.
Participants complete the Modified Version of the Mood Instability Questionnaire-Trait. For each scale item, 0 = not at all true, 1 = hardly true, 2 = moderately true, and 3 = exactly true. Higher scores indicate more mood swings. Higher scores indicate a worse outcome. Results reported relate to the Lability Subscale. Scores on the subscale can range from 0 to 3. Scores for mood swings were calculated by taking the mean of all the Lability Subscale items.
Change From Baseline in Levels of Energy After 1 Month of Drug Usage
时间窗: From day 1 of supplement usage to the end of treatment at 4 weeks.
Participants complete the Multidimensional Fatigue Inventory. For each scale item, 1 = Yes, that is true... 5 = No, that is not true. Higher scores indicate higher energy levels. Higher scores indicate a better outcome. Scores for energy could range from 1 to 5. Scores for energy were calculated by taking the mean of all the scale items.
Change from Baseline in Levels of Perceived Vulnerability to Disease Scale after 1 Month of Drug Usage
时间窗: From day 1 of supplement usage to the end of treatment at 4 weeks.
Participants complete the Perceived Infectability Subscale (Duncan et al., 2009). For each scale item, 1 = Strongly disagree to 7 = Strongly agree. Higher scores indicate a higher perceived vulnerability to disease.
Change from Baseline in Levels of Happiness after 1 Month of Drug Usage
时间窗: From day 1 of supplement usage to the end of treatment at 4 weeks.
Participants complete the Short Depression-Happiness Scale (Joseph et al., 2004). For each scale item, 1 = Never... 4 = Often. Higher scores indicate higher levels of happiness.
Change from Baseline in Levels of Digestive Health after 1 Month of Drug Usage
时间窗: From day 1 of supplement usage to the end of treatment at 4 weeks.
Participants complete a modified version of the Birmingham IBS Symptom Questionnaire (Roalfe et al., 2008). For each scale item, 1: All of the time... 6: None of the time. Higher scores indicate better digestive health.
Change from Baseline in Levels of Mood Swings after 1 Month of Drug Usage
时间窗: From day 1 of supplement usage to the end of treatment at 4 weeks.
Participants complete the Modified Version of the Mood Instability Questionnaire-Trait (Yoon et al., 2021). For each scale item, 0 = not at all true, 1 = hardly true, 2 = moderately true, and 3 = exactly true. Higher scores indicate more mood swings.
Change from Baseline in Levels of Energy after 1 Month of Drug Usage
时间窗: From day 1 of supplement usage to the end of treatment at 4 weeks.
Participants complete the Multidimensional Fatigue Inventory (General Fatigue and Physical Fatigue Subscales; Smets et al., 1995). For each scale item, 1 = Yes, that is true... 5 = No, that is not true. Higher scores indicate higher energy levels.
次要结局
未报告次要终点
研究者
Sarah Hill
Professor
Texas Christian University