Eating HabitNCT05303207
Study to Evaluate the Efficacy of YOUR SUPER Detox Bundle to Improve Perceived Well Being and Promote Adaptation of Healthy Dietary Choices
A study testing YOUR SUPER Detox Bundle in people with Eating Habit and Healthy Diet, run by Your Super, INC. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Eating Habit, Healthy Diet
- What is being tested?
- YOUR SUPER Detox Bundle
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2022to 30 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 16Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Eating Habit, Healthy Diet
- Being tested
- YOUR SUPER Detox Bundle
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YOUR SUPER Detox BundleDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Your Super Detox | Other | Dietary supplement Receives: Dietary Supplement: YOUR SUPER Detox Bundle |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 5 days
Secondary outcomes (1)
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).
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start15 Mar 2022
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating HabitStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open label
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Your Super, INC.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05303207
- Sponsor's protocol ID
- 20233YourSuper
- Status last verified
- Jun 2022
- First submitted
- 21 Mar 2022
- Last updated
- 14 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Evaluate the Efficacy of YOUR SUPER Detox Bundle to Improve Perceived Well Being and Promote Adaptation of Healthy Dietary Choices
- ClinicalTrials.gov ID
- NCT05303207
- Acronym / sponsor ID
- 20233YourSuper
- Conditions
- Eating Habit, Healthy Diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Your Super, INC.Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 31 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label
| Arm | Type | Receives |
|---|---|---|
| Your Super Detox | Other | Dietary Supplement: YOUR SUPER Detox BundleDietary supplement |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YOUR SUPER Detox BundleDuring 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. | Dietary supplement | Your Super Detox |
Primary outcome
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).
1 secondary outcome
Changes in well-being markers of well being
Time frame: 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing YOUR SUPER Detox Bundle in people with Eating Habit and Healthy Diet, run by Your Super, INC. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in perceived commitment to long-term healthy eating habits (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2022.