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| Name | Class |
|---|---|
| AyurPrana LLC | UNKNOWN |
| Pearl Banyan, LLC | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Detoxification cleanse |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 9-day detoxification cleanse and 1 week of pre-cleanse transition | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Microbiota diversity | Evaluation of gut microbiome diversity | 3 weeks |
| Microbiome intestinal markers | Zonulin, calprotectin, antibodies against LPS | 3 weeks |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Raja Sivamani, MD, MS, AP | Contact | 916-524-1216 | raja.sivamani@integrativeskinresearch.com | |
| Mincy Chakkalakal, BS | Contact | 279-204-7338 | mincy@integrativeskinresearch.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Integrative Skin Science and Research | Sacramento | California | 96815 | United States |
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| ID | Term |
|---|---|
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
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All subjects will be given the intervention
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| 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 |