Clinical trial NCT05877365: Effects of 21-day Purification Program on Healthy Adults
Official title: Effects of Standard Process's 21-day Guided Purification Program on Metabolic Health in College Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Purification
Whole Food Vitamins
Detoxification
Lead sponsor: Standard Process Inc.
Sponsor class: INDUSTRY
Collaborators: name: Keiser University College of Chiropractic Medicine
First posted: 2023-05-26
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: diet only vs whole food supplement based intervention
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Porphyrins in Urine
timeFrame: 58 days
Secondary outcomes:
measure: Changes in GGT
timeFrame: 58 days
measure: Changes in GST
timeFrame: 58 days
measure: Questionnaire
timeFrame: 58 days
measure: Changes in Weight
timeFrame: 58 days
Other outcomes:
Locations:
city: West Palm Beach
country: United States
facility: Keiser University Spine Care Clinic
state: Florida
Study officials:
affiliation: Standard Process Inc.
name: Chinmayee Panda, PhD
role: PRINCIPAL_INVESTIGATOR
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