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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04869865
• Other study ID #: AYURCLN-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 29, 2021
• Est. completion date: April 3, 2022

Study information

• Verified date: April 2021
• Source: Integrative Skin Science and Research
• Contact: Raja Sivamani, MD, MS, AP
• Phone: 916-524-1216
• Email: raja.sivamani[@]integrativeskinresearch.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 18
• Est. completion date: April 3, 2022
• Est. primary completion date: April 3, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

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.

Locations

Country	Name	City	State
United States	Integrative Skin Science and Research	Sacramento	California

Sponsors (3)

Lead Sponsor	Collaborator
Integrative Skin Science and Research	AyurPrana LLC, Pearl Banyan, LLC

Country where clinical trial is conducted

United States, 

Outcome

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