Guided Metabolic Detox Program

Standard Process

Status: Completed

Conditions: Detoxification Response

Treatments: Dietary Supplement: SP Detox Program

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06061289

SP-016

Details and patient eligibility

About

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.

Full 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 with a whole food, proprietary multicomponent blend. The primary objective was to determine the improvement in quality of life by a validated self-reported wellness questionnaire known as Promis Global 10. The secondary outcomes were to quantify the functional markers of metabolic detoxification in blood and urine compared to the study baseline to understand the efficacy of the study formulation as part of 28-day nutritional supplementation with a whole food, proprietary multicomponent blend.

Enrollment: 32 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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 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 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

Education and healthy diet

No Intervention group

Description:

The healthy diet education session included a PowerPoint presentation on healthy dietary guidelines and sample recipes of healthy meals.

Detox

Experimental group

Description:

The guided component of the detoxification program included an additional PowerPoint presentation with the information about the investigational product, directions, and dosing information for its consumption.

Treatment:

Dietary Supplement: SP Detox Program