Effects of Standard Process's SP Detox Balance Dietary Supplements on Metabolic Detoxification
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Promis Global 10 (Self- reported Wellness) Questionnaire
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Promis Global 10 (Self- reported Wellness) Questionnaire
时间窗: 28 days
The PROMIS Global short form was scored into a Global Physical Health component and Global Mental Health component. The summed raw scores from PROMIS Global were converted into standardized T-score distributions such that a 50 represents the average (mean) for the US general population. A high score always represents more of the concept being measured.
次要结局
- Detoxification Enzyme Activity - GST(28 days)
- Detoxification Enzyme Activity - SOD(28 days)
- Hepatic detox marker -2(28 days)
- Total Glutathione(28 days)
- Oxidative Stress(28 days)
- Total Serum Antioxidants(28 days)
- Urinary Detox marker(28 days)
- Hepatic detox marker -1(28 days)