Clinical trial NCT04869865: The Effects of a Springtime Home Cleanse on Skin, Gut, Metabolic and Mental Health
Official title: The Effects of a Springtime Home Cleanse on Skin, Gut, Metabolic and Mental Health
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Keywords: mental health
skin health
gut health
Lead sponsor: Integrative Skin Science and Research
Sponsor class: INDUSTRY
Collaborators: name: AyurPrana LLC
name: Pearl Banyan, LLC
First posted: 2021-05-03
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All subjects will be given the intervention
Primary purpose: TREATMENT

Brief summary: This pilot study will evaluate the effects of a Springtime Home Cleanse on skin, gut, metabolic, and mental health. The study will also assess changes in overall quality of life. The results will be used to design a larger cleanse-based study in the future.

Detailed description: Short-term dietary cleanses and other popular detoxification methods are thought to eliminate accumulated toxins from the body and subsequently, promote health and well-being. Although previous studies have reported improvements in weight loss, blood pressure and insulin resistance with these practices, there is not enough scientific evidence to corroborate these claims. Therefore, the objective of this pilot study is to determine the effects of a short-term dietary cleanse on various parameters of skin, gut, metabolic and mental health and evaluate the aforementioned health claims.

Eligibility criteria: Inclusion Criteria:

* Males and females (ages 18-69)
* Individuals must be able to read and comprehend study procedures and consent forms.
* Individuals who have baseline metabolic, gut or stress dysfunction
* Individuals must be able to minimize activity during the home cleanse for full participation and compliance.
* Individuals must be willing to reduce caffeine, sugar, alcohol, dairy and carbohydrate rich foods throughout the study.
* Individuals must be willing to have flash photo facial images taken with imaging systems.

Exclusion Criteria:

* Individuals with a known allergy to lime or lime juice, ginger or ginger pickle, turbinado sugar, rock salt, curcumin, coriander, fennel, cardamom, cinnamon, trikatu, yellow mung dal, kitchari spice, triphala, dashamula and guduchi powder, castor oil and chyavanprash.
* Individuals who are lactose intolerant, or with a known allergy to ghee.
* Individuals who are in the process of being vaccinated.
* Individual who have a history of gastrointestinal inflammatory diseases or a history or diagnosis of immunologic or infectious disease (e.g. hepatitis, tuberculosis, HIV or AIDS, lupus, rheumatoid arthritis) or other similar systemic diseases in the opinion of the investigator.
* Individuals who are recovering from a serious illness (requiring hospitalization), infection (requiring hospitalization), or surgery within one month of starting the study or unwilling to wait one month after their illness, infection, or surgery prior to starting the study.
* Individuals who are recovering from a non-serious illness or infection who are recovered and unwilling to wait 2 weeks from their illness or infection.
* Individuals who are in a concurrent intervention based clinical research study at this site or any other facility in the past two weeks.
* Has a condition or is on a medication the investigator and/or designee believes could jeopardize the safety of the subject, interfere with the evaluation, or confound the interpretation of the study results.
* Individuals who have had exposure to systemic antibiotics within the month prior or unwilling to wash out for a month.
* Women who are pregnant or breastfeeding.
* Individuals who are cognitively impaired.
* Prisoners

Primary outcomes:
measure: Microbiota diversity
timeFrame: 3 weeks
measure: Microbiome intestinal markers
timeFrame: 3 weeks
Secondary outcomes:
measure: Serum hemoglobin A1c (HbA1c) levels
timeFrame: 3 weeks
measure: Serum high-sensitivity C-reactive protein (hsCRP) level
timeFrame: 3 weeks
measure: Serum triglyceride (TG) level
timeFrame: 3 weeks
measure: Serum low density lipoprotein (LDL) level
timeFrame: 3 weeks
measure: Serum high density lipoprotein (HDL) level
timeFrame: 3 weeks
measure: Serum very low density lipoprotein (VLDL) level
timeFrame: 3 weeks
measure: Salivary diurnal cortisol pattern
timeFrame: 3 weeks
measure: Facial redness - image based
timeFrame: 3 weeks
measure: Facial wrinkles - image based
timeFrame: 3 weeks
measure: Facial trans-epidermal water loss (TEWL)
timeFrame: 3 weeks
measure: Tongue changes - image based
timeFrame: 3 weeks
measure: Quality of Life Survey Based Assessment
timeFrame: 3 weeks
measure: Safety assessments for GI distress
timeFrame: 3 weeks
measure: Blood pressure
timeFrame: 3 weeks
measure: Heart Rate
timeFrame: 3 weeks
measure: Respiratory Rate
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Integrative Skin Science and Research
state: California
Study officials:
References: