Study to Evaluate the Efficacy of YOUR SUPER Detox Bundle to Improve Perceived Well Being and Promote Adaptation of Healthy Dietary Choices
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|ClinicalTrials.gov Identifier: NCT05303207|
Recruitment Status : Completed
First Posted : March 31, 2022
Last Update Posted : June 14, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Eating Habit Healthy Diet||Dietary Supplement: YOUR SUPER Detox Bundle||Not Applicable|
This is an open-label observational single-group clinical trial to study the efficacy of a commercial superfood blend and its effect on markers of well-being and improvement of long-term healthy eating habits.
It is hypothesized that the dietary supplement marketed as Your Super Detox Bundle will improve subjective wellbeing and health in trial participants. It is further hypothesized that the accompanying diet plan will promote beneficial nutritional habits that may persist long term outside of the 5-day detox period. Additionally, the included food ingredients are reported to improve energy levels and sleep quality, while reducing unfavorable bloating, aches, and brain fog.
A total of 38 participants will be recruited for the trial following the screening. The trial will be fully remote, a technology platform will be utilized to screen, enroll and capture study data of the participants. Participants will undergo a 5-day detox period involving consuming two smoothies daily (for breakfast and dinner) containing variations of the Your Super Detox food powders as detailed below. Participants are encouraged to follow the provided plant-based nutritional plan for meals and snacks outside of the Your Super smoothie meals. Participant adherence to the provided nutritional plan is not mandatory, and lack of adherence by some participants will provide further data on the effect of the nutritional guidelines on the evaluated outcomes. After the 5-day detox period is completed, participants will be followed on for a subsequent 16 days to evaluate the effect of Your Super Detox bundle and guidelines to influence prolonged healthy eating habits.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||38 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Open label|
|Masking:||None (Open Label)|
|Official Title:||Study to Evaluate the Efficacy of YOUR SUPER Detox Bundle to Improve Perceived Well Being and Promote Adaptation of Healthy Dietary Choices|
|Actual Study Start Date :||March 15, 2022|
|Actual Primary Completion Date :||April 30, 2022|
|Actual Study Completion Date :||April 30, 2022|
Your Super Detox
Dietary Supplement: YOUR SUPER Detox Bundle
During days 1-5, participants will complete the 5-day Your Super Detox, consuming 2 smoothies daily (breakfast and dinner) containing Your Super Detox superfood powders.
- Change in perceived commitment to long-term healthy eating habits [ Time Frame: 5 days ]The study uses a questionnaire to assess the effectiveness of the intervention on a scale from 0-5 (0=Lowest score and 5=Highest score).
- Changes in well-being markers of well being [ Time Frame: 5 days ]The study uses a questionnaire to assess changes in well-being on a scale from 0-5 (0=Lowest score and 5=Highest score).
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 55 Years (Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- Male & Female
- Age 18-55
- Feeling fatigued often
- Eating fast food, such as fries, burgers, pizza, chicken wings, etc. at least twice a week
- Does not exercise regularly
- Does not consume fruits and vegetables regularly
- Must be in generally good health - no unstable, uncontrolled health condition
- BMI under 40
- May feel bloated often
- May experience gas production often
- May experience heartburn
- May experience irritable bowel symptoms
- May experience irregular bowel movements
- May experience regular body aches
- May experience regular joint, back or neck pain
- Must have a body scale at home for regular weigh-in
- Severe chronic conditions, including oncological and psychiatric disorders
- Known to have any severe allergic reactions
- Currently pregnant, breastfeeding, or wanting to become pregnant for the duration of the study
- Participants unwilling to follow the study protocol
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05303207
|United States, California|
|Santa Monica, California, United States, 90404|
|Responsible Party:||Your Super, INC.|
|Other Study ID Numbers:||
|First Posted:||March 31, 2022 Key Record Dates|
|Last Update Posted:||June 14, 2022|
|Last Verified:||June 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|