Clinical trial NCT05303207: Study to Evaluate the Efficacy of YOUR SUPER Detox Bundle to Improve Perceived Well Being and Promote Adaptation of Healthy Dietary Choices
Official title: Study to Evaluate the Efficacy of YOUR SUPER Detox Bundle to Improve Perceived Well Being and Promote Adaptation of Healthy Dietary Choices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eating Habit
Healthy Diet
Lead sponsor: Your Super, INC.
Sponsor class: INDUSTRY
Collaborators: name: Citruslabs
First posted: 2022-03-31
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open label
Primary purpose: OTHER

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.

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.

Eligibility 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

Primary outcomes:
measure: Change in perceived commitment to long-term healthy eating habits
timeFrame: 5 days
Secondary outcomes:
measure: Changes in well-being markers of well being
timeFrame: 5 days
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Citruslabs
state: California
Study officials:
References: