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Study to Evaluate the Efficacy of YOUR SUPER Detox Bundle to Improve Perceived Well Being and Promote Adaptation of Healthy Dietary Choices

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05303207
Recruitment Status : Completed
First Posted : March 31, 2022
Last Update Posted : June 14, 2022
Sponsor:
Collaborator:
Citruslabs
Information provided by (Responsible Party):
Your Super, INC.

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Eating Habit Healthy Diet Dietary Supplement: YOUR SUPER Detox Bundle Not Applicable

Detailed Description:

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Open label
Masking: None (Open Label)
Primary Purpose: Other
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
Arms and Interventions
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Arm Intervention/treatment
Your Super Detox
Dietary supplement
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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).


Eligibility Criteria
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Information from the National Library of Medicine

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.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, California
Citruslabs
Santa Monica, California, United States, 90404
Sponsors and Collaborators
Your Super, INC.
Citruslabs
More Information
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Responsible Party: Your Super, INC.
ClinicalTrials.gov Identifier: NCT05303207    
Other Study ID Numbers: 20233YourSuper
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No