The Effects of a Springtime Home Cleanse on Skin, Gut, Metabolic and Mental Health
试验速览
- 阶段
- 不适用
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Microbiota diversity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Microbiota diversity
时间窗: 3 weeks
Evaluation of gut microbiome diversity
Microbiome intestinal markers
时间窗: 3 weeks
Zonulin, calprotectin, antibodies against LPS
次要结局
- Serum high-sensitivity C-reactive protein (hsCRP) level(3 weeks)
- Safety assessments for GI distress(3 weeks)
- Serum triglyceride (TG) level(3 weeks)
- Quality of Life Survey Based Assessment(3 weeks)
- Respiratory Rate(3 weeks)
- Facial trans-epidermal water loss (TEWL)(3 weeks)
- Blood pressure(3 weeks)
- Serum hemoglobin A1c (HbA1c) levels(3 weeks)
- Serum low density lipoprotein (LDL) level(3 weeks)
- Serum high density lipoprotein (HDL) level(3 weeks)
- Facial wrinkles - image based(3 weeks)
- Serum very low density lipoprotein (VLDL) level(3 weeks)
- Salivary diurnal cortisol pattern(3 weeks)
- Facial redness - image based(3 weeks)
- Heart Rate(3 weeks)
- Tongue changes - image based(3 weeks)