The Effects of a Springtime Home Cleanse on Skin, Gut, Metabolic and Mental Health

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effects of a Springtime Home Cleanse on Skin, Gut, Metabolic and Mental Health

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: 9-day detoxification cleanse and 1 week of pre-cleanse transition


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: All subjects will be given the intervention
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Detoxification cleanse | Dietary Supplement: 9-day detoxification cleanse and 1 week of pre-cleanse transition<br>* Subjects will participate in the full 9-day Springtime Home Cleanse, including the week prior to a pre-cleanse transition period. The cleanse includes a transition week, 9 days of a monodiet, internal oleation with ghee, external oleation, herbs, purgation, and an enema. During this time, subjects will also attend daily online meetings on Facebook Live throughout the cleanse and on AyurPrana's AyurLearn online portal to participate in guided mediation and yoga. Subjects will also use these platforms to access daily cleanse instructions and journaling topics.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbiota diversity | Evaluation of gut microbiome diversity | 3 weeks | 
| Microbiome intestinal markers | Zonulin, calprotectin, antibodies against LPS | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum hemoglobin A1c (HbA1c) levels | Evaluate serum HbA1c level via ZRT Laboratories Cardiometabolic Panel | 3 weeks | 
| Serum high-sensitivity C-reactive protein (hsCRP) level | Evaluate serum hsCRP level via ZRT Laboratories Cardiometabolic Panel | 3 weeks | 
| Serum triglyceride (TG) level | Evaluate serum TG level via ZRT Laboratories Cardiometabolic Panel | 3 weeks | 
| Serum low density lipoprotein (LDL) level | Evaluate serum LDL level via ZRT Laboratories Cardiometabolic Panel | 3 weeks | 
| Serum high density lipoprotein (HDL) level | Evaluate serum HDL level via ZRT Laboratories Cardiometabolic Panel | 3 weeks | 
| Serum very low density lipoprotein (VLDL) level | Evaluate serum VLDL level via ZRT Laboratories Cardiometabolic Panel | 3 weeks | 
| Salivary diurnal cortisol pattern | Salivary diurnal cortisol pattern via ZRT Laboratories Saliva Hormone Test | 3 weeks | 
| Facial redness - image based | BTBP Clarity Mini 3D camera | 3 weeks | 
| Facial wrinkles - image based | BTBP Clarity Mini 3D camera | 3 weeks | 
| Facial trans-epidermal water loss (TEWL) | Vapometer, Delfin Technologies | 3 weeks | 
| Tongue changes - image based | Evaluate changes in tongue coating, discoloration, depressions, indentations, and cracking via iPad imaging | 3 weeks | 
| Quality of Life Survey Based Assessment | Self assessment using World Health Organization (WHO) Quality of Life Questionnaire | 3 weeks | 
| Safety assessments for GI distress | Self assessment using Digestive Questionnaire | 3 weeks | 
| Blood pressure |  | 3 weeks | 
| Heart Rate |  | 3 weeks | 
| Respiratory Rate |  | 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mental health, skin health, gut health