Healthy
Conditions
Keywords
Purification, Whole Food Vitamins, Detoxification
Brief summary
This is a study to assess the impact of Standard Process's 21-Day Purification Program on metabolic health. Participants will be given the opportunity to consume the complex combination of vitamins, minerals, and antioxidants that comprise the 21-Day Guided Purification Program by Standard Process.
Detailed description
Purification, also known as detoxification, may help remove natural toxins from the body, while maintaining a healthy weight. The toxin load we are exposed to daily may take a toll on our physical and emotional well-being. Internally, human bodies produce waste byproducts because of normal metabolic function. Although the human body is designed to rid itself of these toxins naturally, it can become overburdened. Purification may offer the body additional support to expel these toxins and manage weight, which is important to maintaining health and vitality.
Interventions
DIETARY_SUPPLEMENTStandard Process 21-Day Purification Program
Purification, also known as detoxification, may help remove natural toxins from the body, while maintaining a healthy weight. The toxin load humans are exposed to daily may take a toll on physical and emotional well-being. Internally, human bodies produce waste byproducts because of normal metabolic function. Although the body is designed to rid itself of these toxins naturally, it can become overburdened. Purification may offer the body additional support to expel these toxins and manage weight, which is important to maintaining health and vitality.
Sponsors
Keiser University College of Chiropractic Medicine
Standard Process Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)
Intervention model description
diet only vs whole food supplement based intervention
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Subject has voluntarily signed and dated an informed consent form, approved by an Institutional Review Board/Independent Ethics Committee. * Willingness to comply with study protocol for 58 days * Willingness to come and provide samples on all 4 study visits * No allergy to any study products (a complete list of what supplements will assist is provided below)) * Subject is \>18 years of age * Subject is a male or a non-pregnant, non-lactating female, at least 6 weeks postpartum prior to screening visit, and is not actively planning a pregnancy * If on a chronic medication (that does not result in exclusion), subject has been on stable dose for at least two months prior to screening visit * Subject has at least two weeks wash out period between completion of a previous research study that required ingestion of any study food or drug and their start in the current study * Willingness to stay compliant for 22 days and not participate in another research study
Exclusion criteria
* Prohibited Medications, Supplements or Herbal Products * Subjects who are experiencing any adverse events due to any nutraceutical, OTC, or pharmaceutical or investigational products * Celiac and other gastrointestinal health concerns * Subjects may not receive any other investigational products not part of normal clinical care * Lipid lowering drugs in the preceding 4 weeks and for duration of study \[examples- statins, cholesterol absorption inhibitors like Ezetimibe (Zetia), PCSK9 inhibitors like Alirocumab (Praluent), Evolocumab (Repatha) etc.\] * The use of anticoagulant medications in the preceding 4 weeks and for duration of study \[Examples: apixaban (Eliquis), betrixaban (Bevyxxa), edoxaban (Savaysa), and rivaroxaban (Xarelto) etc.\] * Pregnant and nursing women are excluded from participation and women of childbearing age expecting to be pregnant soon will be excluded from the study * Subjects with untreated endocrine, neurological, or infectious disease * Subjects with the diagnosis of HIV disease or AIDS * Significant liver or kidney disease (recent or ongoing hepatitis, cirrhosis, glomerulonephritis, dialysis treatment) * Rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematosus, polymyositis, scleroderma, polymyalgia rheumatic, temporal arteritis or Reiter's Syndrome * Psoriasis, Deep vein thrombosis or pulmonary embolus (blood clot to lungs) * History of cancer * Serious medical illness like high TG levels \>150 mg/DL for example * Substance Use - Use of ethanol within 24 hours of the evaluation visits (all 4 visits) * Any other sound medical, psychiatric and/or social reason as determined by the PI * Co-enrollment in other studies is restricted. Study staff should be notified of co-enrollment as it may require the approval of the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Porphyrins in Urine | 58 days | Using a kit, urinary porphyrins will be measured. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in GGT | 58 days | A blood draw will be performed to evaluate gamma-glutamyl transferase (GGT) levels |
| Changes in GST | 58 days | A blood draw will be performed to evaluate Glutathione S-Transferase (GST) levels |
| Questionnaire | 58 days | PROMIS Global 10 Health Questionnaire will be used for the participant to evaluate their own health on a scale from 1-5. |
| Changes in Weight | 58 days | Participants will be weighed at each visit to help evaluate health |
Countries
United States
Outcome results
None listed