Safety Evaluation of a Diet and Nutritional Supplementation Program for Support of Balanced Bowel Function in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Number of participants with treatment-related adverse events (AEs) as assessed by Common Terminology Criteria for Adverse Events v4.0 (CTCAE v4.0).
研究概览
简要总结
The study evaluated the safety, tolerability and acceptability of a lifestyle modification program with nutritional supplementation designed to restore balance to healthy bowel function in generally healthy subjects
详细描述
To investigate the safety, tolerance and acceptability of a lifestyle modification and targeted nutraceuticals for balanced bowel function in generally healthy volunteers. To evaluate safety and tolerability, blood samples were drawn for blood counts, metabolic profiles, plasma lipids, and additional cardiovascular risk factors. Quality of life questionnaires, medical symptom questionnaire were evaluated at baseline, week 1, week 2 and week 4. Vitals signs, weight and body composition were monitored at each visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women ≥ 18 and ≤ 69 years old
- •Generally healthy and meeting entrance criteria
- •Score ≥ 8 points on the Purify Readiness Scale (Appendix B)
- •Willingness to make required lifestyle changes during study participation
- •Ability to understand and the willingness to sign a written informed consent document
排除标准
- •Change in prescription medications, over-the-counter medications, medical foods, and nutritional supplements within 30 days prior to Day 1 and for the duration of the study.
- •Use of medications classified as narcotics 15 days prior to Day 1 and for the duration of the study.
- •Use of prescription medications and/or over-the-counter medications for acute and semi-acute medical conditions 15 days prior to Day 1 and for the duration of the study. Use of acetaminophen is permitted on an as-needed basis.
- •Use of an investigational drug or participation in an investigational study within 30 days prior to Day 1 and for the duration of the study.
- •Use of oral or injectable corticosteroids within 30 days prior to Day 1 and for the duration of the study.
- •Use of anticoagulant medications (heparin compounds, platelet inhibitors or warfarin) within 30 days prior to Day 1 and for the duration of the study. Use of aspirin 81 mg or 325 mg once daily is permitted.
- •Use of neuro-active prescription medications specifically major and atypical antipsychotic medications within 30 days prior to Day 1 and for the duration of the study.
- •Use of prescription medications, over-the-counter medications, medical foods, and nutritional supplements for the treatment of hyperlipidemia within 30 days prior to Day 1 and for the duration of the study.
- •Use of prescription medications, over-the-counter medications, medical foods, and nutritional supplements for the treatment of hyperglycemia within 30 days prior to Day 1 and for the duration of the study.
研究组 & 干预措施
Prog: Purify-2
All subjects will be participating in a diet life style modification program (High Phytopro dietary program) ( a modified Mediterranean style low glycemic load food plan) and will be receiving a supportive nutritional supplements over a 4 week period.
干预措施: Prog: Purify-2 (Other)
结局指标
主要结局
Number of participants with treatment-related adverse events (AEs) as assessed by Common Terminology Criteria for Adverse Events v4.0 (CTCAE v4.0).
时间窗: 4 weeks
Data collection at individual and group visits and physician interviews at individual visits (baseline, week 1, week 2 and week 4) will be used to assess participants for treatment-related adverse events. Subjects with ongoing AEs may be followed for an additional 4 weeks at the discretion of the PI.
次要结局
- Changes in blood pressure and peripheral pulse compared to baseline(4 weeks)
- Changes in total branch chain amino acids levels compared to baseline(4 weeks)
- Changes in Total Antioxidant Capacity (TAC) levels as Trolox Equivalent (TE) compared to baseline(4 weeks)
- Changes in serum Zonulin levels compared to baseline(4 weeks)
- Changes in weight in pounds compared to baseline(4 weeks)
- Changes in inflammatory marker (high sensitivity C-reactive protein (hs-CRP) in mg/L) to identify low levels of inflammation that can be associated with conditions like cardiovascular disease compared to baseline(4 weeks)
- Changes in gastrointestinal Quality of Life questionnaire with Bristol Stool Chart scores compared to baseline(4 weeks)
- Changes in Medical Symptom Questionnaire compared to baseline(4 weeks)
- Changes in lipid panel compared to baseline(4 weeks)
- Changes in Gammaglutamyl transferase (GGT) in U/L compared to baseline(4 weeks)
- Changes in inflammatory markers levels including calprotectin, secretory Immunoglobulin A (IgA), and eosinophil-derived neurotoxin(4 weeks)
- Changes in Thiobarbituric acid (TBARS/Malondialdehyde) compared to baseline(4 weeks)
- Changes in waist circumference in inches compared to baseline(4 weeks)
- Changes in Quality of life questionnaire [Medical Outcomes Study-Short Form 36 (MOS-SF36)] compared to baseline(4 weeks)
- Number of participants with treatment-related changes in basic safety labs(4 weeks)
- Changes in body fat in percentage compared to baseline(4 weeks)
- Changes in body mass index (BMI) in kg/m2 compared to baseline(4 weeks)
- Changes in fasting Glucose and Insulin compared to baseline(4 weeks)
- Changes in myeloperoxidase (MPO) levels compared to baseline(4 weeks)
- Changes in Heme Oxygenase-1 (HO-1) levels in ng/ml compared to baseline(4 weeks)
- Changes in Trimethylamine N-oxide/ Asymmetric dimethylarginine/ Symmetric dimethylarginine (TMAO/ADMA/SDMA) levels compared to baseline(4 weeks)
- Changes in metallothionein protein levels compared to baseline(4 weeks)
- Changes in Lactulose/Mannitol ratio in 24-hour urine collected samples compared to baseline(4 weeks)
- Changes in urine toxic element levels compared to baseline(4 weeks)
- Changes in stool short chain fatty acids (SCFAs) levels including n-butyrate, propionate and acetate compared to baseline(4 weeks)
- Changes in sodium copper chlorophyllin levels compared to baseline(4 weeks)
- Changes in stool Zonulin levels compared to baseline(4 weeks)
- Changes in stool Firmicutes count, Bacteroidetes count, and Firmicutes/Bacteroidetes ratio compared to baseline(4 weeks)