Clinical trial NCT05858476: An Investigation Into a 21-Day Detoxification Diet With a Seven-Day Continuation
Official title: An Investigation Into a 21-Day Detoxification Diet With a Seven-Day Continuation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Detoxification
Lead sponsor: Chef V, LLC
Sponsor class: INDUSTRY
Collaborators: name: Citruslabs
First posted: 2023-05-15
Enrollment: 38
Sex: ALL
Minimum age (years): 31
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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.
* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Changes in participant perceptions of well-being [Time Frame: Baseline to 28 days)
timeFrame: 28 days
Secondary outcomes:
measure: Change in hs-CRP [Time Frame: Baseline to 28 days]
timeFrame: 28 days
measure: Change in blood lipid profile [Time Frame: Baseline to 28 days]
timeFrame: 28 days
measure: Change in HbA1C [Time Frame: Baseline to 28 days]
timeFrame: 28 days
measure: Change in bodyweight [Time Frame: Baseline to 28 days]
timeFrame: 28 days
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Citruslabs
state: California
Study officials:
References: