Status:
COMPLETED
Guided Metabolic Detox Program
Lead Sponsor:
Standard Process Inc.
Collaborating Sponsors:
Northwestern Health Sciences University
Conditions:
Detoxification Response
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Adequate antioxidant supply is essential for maintaining metabolic homeostasis and reducing oxidative stress during detoxification. The emerging evidence suggests that certain classes of phytonutrient...
Detailed Description
In this study, the focus is on a cohort of healthy adults enrolled in a guided detoxification program that included a healthy diet education session with or without 28-day nutritional supplementation ...
Eligibility Criteria
Inclusion
- Willingness to comply with study protocol for 30 days
- No allergy to any study products (check formulation section below)
- Participant is over 18 years of age or older
- Participant 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.
- Participant 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.
Exclusion
- 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 or the use of anticoagulant medications in the preceding 4 weeks and for duration of study
- Pregnant and nursing women are excluded from participation and women of childbearing age expecting to be pregnant soon will be excluded from the study
- TC levels less than 220
- 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
- Substance Use - Use of ethanol within 24 hours of the evaluation visits (baseline, 4 weeks)
- 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
Key Trial Info
Start Date :
March 6 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2022
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT06061289
Start Date
March 6 2022
End Date
September 30 2022
Last Update
September 29 2023
Active Locations (1)
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1
De-Rusha Clinic, Northwestern Health Sciences University
Bloomington, Minnesota, United States, 55431