DetoxificationNCT05858476
An Investigation Into a 21-Day Detoxification Diet With a Seven-Day Continuation
A study testing 21-Day Detox and Green Drink supplement in people with Detoxification, run by Chef V, LLC at 1 site in United States.
Trial summary
Detoxification diets aim to remove chemicals from the body that may cause short or long-term harm. However, little is known about detoxification diets from well-designed clinical trials. This trial examines the efficacy of Chef V's 21-Day Starter Challenge Detox diet. Read more about this study
- Who is it for?
- Ages 31 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Detoxification
- What is being tested?
- 21-Day Detox and Green Drink supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Dec 2022to 20 Feb 2023
- 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 31 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must be in good general health with no chronic health conditions
- BMI under 35.
- Must own a scale at home.
- Must experience at least one of the following issues: the feeling of being tired at least several times a week, brain fog, sleep issues, trouble with focus and concentration, or having a busy, stressful life.
- A subgroup of 10 study participants must be diagnosed with T2D for ≥ 90 days, with an hbA1c of 7.5 to 10.5, inclusive
- Eat fast food at least twice a week.
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- Does not exercise regularly.
- Does not consume fruits and vegetables daily.
- Must experience at least one of the following gastrointestinal problems: often bloating, excessive gas, heartburn, and irregular bowel movements.
- Must experience at least one of the following aches regularly: body aches, joint pain, back pain, or neck pain.
- Must be willing to go to Quest labs for two blood draws, one at baseline and the other at the study's conclusion.
- Willing to avoid bottled water for the duration of the study.
Who cannot join
- Suffers from pre-existing conditions that prevent them from adhering to the protocol.
- Anyone with known severe allergic reactions.
- Currently pregnant, breastfeeding, or wanting to become pregnant for the duration of the study.
- Anyone unwilling to use the test product daily as directed.
Trial locations and contacts
1 site in 1 country.
About this study
Detoxification diets aim to remove chemicals from the body that may cause short or long-term harm. However, little is known about detoxification diets from well-designed clinical trials. This trial examines the efficacy of Chef V's 21-Day Starter Challenge Detox diet. Participants will use Chef V's 21-Day Starter Challenge Detox as directed for the first 21 days of the trial and continue to use the Chef V Green Drink Supplement for an additional seven days. The primary outcomes of interest are the participant's perceptions of their health improvements and biomarkers that will be measured via blood draws.
- Conditions
- Detoxification
- Being tested
- 21-Day Detox and Green Drink supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
21-Day Detox and Green Drink supplementOther
Detox plan description:
7AM Water 16oz. 8AM Green Drink 16oz. 9AM Ultra Shake 16oz. 9-12PM Water 24 - 48oz. 12PM Green Drink 16oz. 12:30 - 2PM Water 24 - 48oz. 2PM Green Drink 16oz. 3PM Ultra Shake 16oz. 3:30- 6PM Water 24 - 48oz. 6PM Green Drink 16oz. 7PM Detox Soup 16oz. 7:30 - 10PM Water 24 - 48oz. This 21-day period will be followed by 7 days of consuming the Green Drink Supplement.
| Study group | Role | What they receive |
|---|---|---|
| Chef V's 21-Day Starter Challenge Detox & Green Drink Supplement | Experimental | The detox program provides the three primary macronutrients alongside antioxidants to promote detoxification. The 21-Day Detox schedule is below:
Days 1-7: Healthy Routine- The Healthy Routine involves drinking a 16oz Green Drink and Protein Shake for breakfast and then choosing their lunch, snack, and dinner from the Meal Planner that will be provided.
Days 8-10: 3-Day Cleanse- Each day during the three-day cleanse, participants will consume 4 16oz Green Drinks, 2 Protein Shakes, and a Soup designed explicitly to detox the body.
Days 11-21: Healthy Routine- The last period of the 21 days will mimic the Healthy Routine from Days 1-7.
Days 21-28 Participants will follow up this program by using the Green Drink supplement provided for an additional 7 days. Receives: Other: 21-Day Detox and Green Drink supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in participant perceptions of well-being [Time Frame: Baseline to 28 days)
Survey-based assessment (0-5 scale) of changes in IBS symptoms). Participants will answer surveys at the study baseline, and on Days 5, 11, 21 and 28 of the trial.
Measured: 28 days
Secondary outcomes (4)
Change in hs-CRP [Time Frame: Baseline to 28 days]
Blood draws will be taken at Baseline and Day 28 for comparison.
Measured: 28 days
Change in blood lipid profile [Time Frame: Baseline to 28 days]
Blood draws will be taken at Baseline and Day 28 for comparison.
Measured: 28 days
Change in HbA1C [Time Frame: Baseline to 28 days]
Blood draws will be taken at Baseline and Day 28 for comparison.
Measured: 28 days
Change in bodyweight [Time Frame: Baseline to 28 days]
Weight will be measured using an electric scales at the study baseline and on Days 3, 5, 14, and 18.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2023
- Study start2 Dec 2022
- Primary completion10 Feb 2023
- Study completion20 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DetoxificationStudies 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
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chef V, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05858476
- Sponsor's protocol ID
- 20267
- Status last verified
- May 2023
- First submitted
- 22 Apr 2023
- Last updated
- 15 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation Into a 21-Day Detoxification Diet With a Seven-Day Continuation
- ClinicalTrials.gov ID
- NCT05858476
- Acronym / sponsor ID
- 20267
- Conditions
- Detoxification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Chef V, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Study start
- 2 Dec 2022 (actual)
- Primary completion
- 10 Feb 2023 (actual)
- Study completion
- 20 Feb 2023 (actual)
- First posted
- 15 May 2023 (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.
Detoxification diets aim to remove chemicals from the body that may cause short or long-term harm. However, little is known about detoxification diets from well-designed clinical trials. This trial examines the efficacy of Chef V's 21-Day Starter Challenge Detox diet. Participants will use Chef V's 21-Day Starter Challenge Detox as directed for the first 21 days of the trial and continue to use the Chef V Green Drink Supplement for an additional seven days. The primary outcomes of interest are the participant's perceptions of their health improvements and biomarkers that will be measured via blood draws.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chef V's 21-Day Starter Challenge Detox & Green Drink Supplement | Experimental | Other: 21-Day Detox and Green Drink supplementThe detox program provides the three primary macronutrients alongside antioxidants to promote detoxification. The 21-Day Detox schedule is below: Days 1-7: Healthy Routine- The Healthy Routine involves drinking a 16oz Green Drink and Protein Shake for breakfast and then choosing their lunch, snack, and dinner from the Meal Planner that will be provided. Days 8-10: 3-Day Cleanse- Each day during the three-day cleanse, participants will consume 4 16oz Green Drinks, 2 Protein Shakes, and a Soup designed explicitly to detox the body. Days 11-21: Healthy Routine- The last period of the 21 days will mimic the Healthy Routine from Days 1-7. Days 21-28 Participants will follow up this program by using the Green Drink supplement provided for an additional 7 days. |
Who may qualify
- Ages
- 31 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Must be in good general health with no chronic health conditions
- BMI under 35.
- Must own a scale at home.
- Must experience at least one of the following issues: the feeling of being tired at least several times a week, brain fog, sleep issues, trouble with focus and concentration, or having a busy, stressful life.
- A subgroup of 10 study participants must be diagnosed with T2D for ≥ 90 days, with an hbA1c of 7.5 to 10.5, inclusive
Key exclusion criteria (4 listed)
- Suffers from pre-existing conditions that prevent them from adhering to the protocol.
- Anyone with known severe allergic reactions.
- Currently pregnant, breastfeeding, or wanting to become pregnant for the duration of the study.
- Anyone unwilling to use the test product daily as directed.
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 |
|---|---|---|
| 21-Day Detox and Green Drink supplementDetox plan description: 7AM Water 16oz. 8AM Green Drink 16oz. 9AM Ultra Shake 16oz. 9-12PM Water 24 - 48oz. 12PM Green Drink 16oz. 12:30 - 2PM Water 24 - 48oz. 2PM Green Drink 16oz. 3PM Ultra Shake 16oz. 3:30- 6PM Water 24 - 48oz. 6PM Green Drink 16oz. 7PM Detox Soup 16oz. 7:30 - 10PM Water 24 - 48oz. This 21-day period will be followed by 7 days of consuming the Green Drink Supplement. | Other | Chef V's 21-Day Starter Challenge Detox & Green Drink Supplement |
Primary outcome
Changes in participant perceptions of well-being [Time Frame: Baseline to 28 days)
Time frame: 28 days
Survey-based assessment (0-5 scale) of changes in IBS symptoms). Participants will answer surveys at the study baseline, and on Days 5, 11, 21 and 28 of the trial.
4 secondary outcomes
Change in hs-CRP [Time Frame: Baseline to 28 days]
Time frame: 28 days
Change in blood lipid profile [Time Frame: Baseline to 28 days]
Time frame: 28 days
Change in HbA1C [Time Frame: Baseline to 28 days]
Time frame: 28 days
Change in bodyweight [Time Frame: Baseline to 28 days]
Time frame: 28 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 15 May 2023.
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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 21-Day Detox and Green Drink supplement in people with Detoxification, run by Chef V, LLC 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 12 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 15 May 2023. 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?
Changes in participant perceptions of well-being [Time Frame: Baseline to 28 days) (time frame: 28 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 15 May 2023.