Clinical trial NCT06061289: Guided Metabolic Detox Program
Official title: Effects of Standard Process's SP Detox Balance Dietary Supplements on Metabolic Detoxification
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Detoxification Response
Keywords: Detoxification
Whole Food Vitamins
Glutathione
liver
antioxidants
SOD
GST
Lead sponsor: Standard Process Inc.
Sponsor class: INDUSTRY
Collaborators: name: Northwestern Health Sciences University
First posted: 2023-09-29
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: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 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.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Promis Global 10 (Self- reported Wellness) Questionnaire
timeFrame: 28 days
Secondary outcomes:
measure: Total Serum Antioxidants
timeFrame: 28 days
measure: Oxidative Stress
timeFrame: 28 days
measure: Detoxification Enzyme Activity - SOD
timeFrame: 28 days
measure: Detoxification Enzyme Activity - GST
timeFrame: 28 days
measure: Urinary Detox marker
timeFrame: 28 days
measure: Hepatic detox marker -1
timeFrame: 28 days
measure: Hepatic detox marker -2
timeFrame: 28 days
measure: Total Glutathione
timeFrame: 28 days
Other outcomes:
Locations:
city: Bloomington
country: United States
facility: De-Rusha Clinic, Northwestern Health Sciences University
state: Minnesota
Study officials:
affiliation: Standard Process Inc.
name: Chinmayee Panda, PhD
role: PRINCIPAL_INVESTIGATOR
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