Guided Metabolic Detox Program

Completed · Not applicable

Conditions studied: Detoxification Response

In brief

Adequate antioxidant supply is essential for maintaining metabolic homeostasis and reducing oxidative stress during detoxification. The emerging evidence suggests that certain classes of phytonutrients can help support the detoxification process by stimulating the liver to produce detoxification enzymes or acting as antioxidants that neutralize the harmful effects of free radicals. This study was designed to examine the effects of a guided 28-day metabolic detoxification program in healthy adults. The participants were randomly assigned to consume a whole food, multi-ingredient supplement (education and intervention) or control (education and healthy meal) daily for the duration of the trial.

Key facts

Study ID

NCT06061289

Run by

Standard Process Inc.

People needed

32

Starts

2022-03-06

Expected to finish

2022-09-30

Last updated by the study team

2023-09-29

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• De-Rusha Clinic, Northwestern Health Sciences University — Bloomington, Minnesota, United States

Full record on ClinicalTrials.gov

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