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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Diet; Eating Habit
• Intervention / Treatment: Dietary supplement: YOUR SUPER Detox Bundle

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 Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Santa Monica, California, United States, 90404
      • Citruslabs

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in perceived commitment to long-term healthy eating habits	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).	5 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in well-being markers of well being	The study uses a questionnaire to assess changes in well-being on a scale from 0-5 (0=Lowest score and 5=Highest score).	5 days

Collaborators and Investigators

• Sponsor: Your Super, INC.
• Collaborators: Citruslabs

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2022
• Primary Completion (Actual): April 30, 2022
• Study Completion (Actual): April 30, 2022

Study Registration Dates

• First Submitted: March 21, 2022
• First Submitted That Met QC Criteria: March 21, 2022
• First Posted (Actual): March 31, 2022

Study Record Updates

• Last Update Posted (Actual): June 14, 2022
• Last Update Submitted That Met QC Criteria: June 10, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 20233YourSuper

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No