Digestive Health, Energy, Happiness, Mood Swings, Nutrient Deficiency, Vulnerability to Disease
Conditions
Keywords
Hormonal Birth Control, Nutritional Depletion, Dietary Supplement
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTAlii Supplement
Seeking to examine how a supplement aiming to improve nutrition levels in hormonal birth control users may improve symptoms related to nutritional depletion. Per serving (3 capsules), the supplement contains 90 mg of Vitamin C, 25 μg of Vitamin D3, 135 mg of Vitamin E, 100 mg of Vitamin B1, 50 mg of Vitamin B2, 50mg of Vitamin B3, 50 mg of Vitamin B6, 567 μg DFE of Folate, 250 μg of Vitamin B12, 20mg of Pantothenic Acid, 100mg of Magnesium, 11mg of Zinc, 200 μg of Selenium, 300 mg of Tributyrin, and 50 mg of Coenzyme Q 10. The supplement also contains Hypromellose, Silicon Dioxide, Microcrystalline Cellulose, Magnesium Stearate, and Stearic Acid.
Sponsors
Texas Christian University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 25 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Levels of Perceived Vulnerability to Disease Scale After 1 Month of Drug Usage | 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 | 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 | 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 | 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 | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSarah E Hill, PhD
Texas Christian University
Participant flow
Pre-assignment details
There were not enough participants who were willing and eligible to take part in the study to reach the target sample size. Moreover, recruitment cannot continue as the supplement formulation is changing to a gummy. Thus, all participants received the nutritional supplement. Research assistants and participants were unaware that the participants all received the nutritional supplement as the determination to end the study without the placebo was made after the in person part 1 sessions ended.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized Age 18-25 Years | 16 Participants |
| Digestive Health | 1.54 Score on a scale STANDARD_DEVIATION 0.52 |
| Energy | 3.31 Score on a scale STANDARD_DEVIATION 0.78 |
| Happiness | 3.49 Score on a scale STANDARD_DEVIATION 0.38 |
| Mood Swings | 1.98 Score on a scale STANDARD_DEVIATION 0.67 |
| Perceived Infectability | 4.09 Score on a Scale STANDARD_DEVIATION 1.47 |
| Race/Ethnicity, Customized Black / African American | 1 Participants |
| Race/Ethnicity, Customized Hispanic/Latino | 3 Participants |
| Race/Ethnicity, Customized Mixed Race | 6 Participants |
| Race/Ethnicity, Customized White/Caucasian | 6 Participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 16 |
| other Total, other adverse events | 1 / 16 |
| serious Total, serious adverse events | 0 / 16 |
Outcome results
None listed