Research & Development

The impact of a 21-day physician-supervised detoxification protocol on patient outcomes targeting clinical improvement in metabolic markers, weight, and overall health & wellness

G. Norcross, DOF. Yemofio, MD MPH FACP CPIJ. Pulicharam, MD CPIS. Kawahara, Pharm DT. Norcross, DOJ. Kennedy, MDC. Kim, Pharm DSalgado, CCRC PMPD. Moosad, DCN. Miller, RN MBAN. Bakhta, Pharm DF. Khan, MD CPI

HealthCare Partners Medical GroupNorcross Family MedicineNuvayda Integrative Medical CentreAdnab Research

Introduction

The liver plays a major role in detoxifying the body through oxidation, reduction and hydrolysis (Phase I) and conjugation (Phase II) from potential toxic chemical insults. Overloading these two detoxification pathways can lead to a buildup of fat-soluble toxins that accumulate in fatty organs such as the liver, fat tissues, the brain and the endocrine glands. This deposition of fat is the groundwork for metabolic syndrome and promotes some of the premature aging processes, such as early signs and symptoms of cardiac disease, brain dysfunction and endocrine disorders. For optimal functioning of the Phase 1 and Phase 2 detoxification processes, the liver requires essential vitamins, amino acids and minerals. These are essential because our body does not synthesize them and is dependent on these necessary nutrients from diet.

Objective

Our primary objective was to evaluate the clinical outcomes and efficacy of a 21-day Liver and Gut Purification/Cleansing protocol (Rejuvalyte) on overall health. This was measured by the SF-36 Health Survey, lab values of LDL, Triglycerides, HbA1c, CRP, blood pressure, waist circumference, weight and the improvement in dietary choices.

Methods

The Rejuvalyte Protocol is a physician-supervised nutritional supplement protocol with diet and lifestyle modification to support the Phase 1 and Phase 2 detoxification processes of the liver. It provides support to the gut by maximizing nutrition and minimizing exposure to toxins and helps maintain a balanced intestinal flora thus regulating healthy elimination. Patients were included in the study if they were at least 18 years of age and had serum levels of LDL > 129 mg/dL with or without lipid lowering medication. Diabetic patients were enrolled if their LDL levels were >100 mg/dL. Patients were randomized in a 1:1 ratio to receive either the detoxing intervention or regular diet. All patients received educational materials from the dieticians on making healthy food choices. A total of 300 patients were in the intervention arm and a similar number of subjects were in the control arm with diet counseling alone. These patients were recruited from multiple primary care clinics and enrolled into the IRB-approved clinical trial. Patients were evaluated and clinical outcomes were assessed at baseline, 4 weeks ,12 weeks and 6 months. We reported the change from baseline for all endpoints at 4 weeks, 12 weeks and 6 months. Patient demographics were similar between the two groups and so were the clinical characteristics at baseline.

Results

Compared to the control arm, patients who received the detox supplement showed a significantly higher reduction at 4 weeks from baseline in LDL scores (-30.7 mg/dL vs +2.0 mg/dL), Triglycerides (-49.5 mg/dL vs -5 mg/dL), CRP (-2mg/dL vs 0 mg/dL) and weight (-7.8 lbs vs +2.0 lbs). These improvements in the detox arm were sustained at 3 months with further reduction in LDL by an additional 7%, in Triglycerides by 16%, in CRP by 0.5%, and body weight by 10 lbs. Conversely, clinical outcomes at 6 months deteriorated among patients in the control arm such that LDL was increased by 1%, Triglycerides by 16%, CRP by 0.5 mg/dL, however, body weight decreased by 5lbs from 4 weeks. A significant improvement in the quality of life measures was also reported among patients in the detox arm at 4 weeks that was sustained at 12 weeks and 3 months.