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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: 9-day detoxification cleanse and 1 week of pre-cleanse transition

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.

• Study Type: Interventional
• Enrollment (Anticipated): 18
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Raja Sivamani, MD, MS, AP; Phone Number: 916-524-1216; Email: raja.sivamani@integrativeskinresearch.com
• Study Contact Backup: Name: Mincy Chakkalakal, BS; Phone Number: 279-204-7338; Email: mincy@integrativeskinresearch.com

Study Locations

• United States
  • California
    • Sacramento, California, United States, 96815
      • Integrative Skin Science and Research
      • Contact: Raja Sivamani, MD, MS, AP; Phone Number: 916-524-1216; Email: raja.sivamani@integrativeskinresearch.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intervention; Detoxification cleanse

Dietary supplement: 9-day detoxification cleanse and 1 week of pre-cleanse transition; 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.

What is the study measuring?

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
Blood pressure		3 weeks
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
Heart Rate		3 weeks
Respiratory Rate		3 weeks

Collaborators and Investigators

• Sponsor: Integrative Skin Science and Research
• Collaborators: AyurPrana LLC; Pearl Banyan, LLC

Study record dates

Study Major Dates

• Study Start (Anticipated): April 29, 2021
• Primary Completion (Anticipated): April 3, 2022
• Study Completion (Anticipated): April 3, 2022

Study Registration Dates

• First Submitted: April 29, 2021
• First Submitted That Met QC Criteria: April 29, 2021
• First Posted (Actual): May 3, 2021

Study Record Updates

• Last Update Posted (Actual): May 3, 2021
• Last Update Submitted That Met QC Criteria: April 29, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: mental health; gut health; skin health
• Other Study ID Numbers: AYURCLN-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No