The Influence of Tomato Soy Juice on Inflammation in Overweight and Obese Adults
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Interleukin 6
研究概览
简要总结
The primary objective of this study is to determine if tomato-soy juice can reduce inflammation, which is linked to chronic disease
详细描述
The aim of this study is to improve understanding of how diet can ameliorate the state of chronic inflammation. Short term inflammation is an important part of the body's response to injury, but long term inflammation, as happens in the state of obesity, can result in a multitude of secondary problems, like cancer, diabetes, and cardiovascular disease. Using a novel tomato-soy juice, we aim to demonstrate the potential of tomato-soy juice for reducing inflammation in adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Between 30 and 75 years old
- •Voluntarily agree to participate and sign an informed consent document
排除标准
- •Aged < 30 years or > 75 years
- •Known allergy or intolerance to tomatoes or soy
- •BMI < 30 or > 45 kg/m2
- •Blood plasma glucose > 125 mg/dL
- •Blood plasma/serum triglycerides > 250 mg/dL
- •Blood plasma/serum cholesterol > 240 mg/dL
- •Diabetes requiring the use of diabetes pills, insulin, or non-insulin shots
- •Previous bariatric or gastrointestinal surgery affecting absorption
- •Suspected or known strictures, fistulas or physiological/mechanical gastrointestinal obstruction
- •Presence of gastrointestinal or malabsorptive disorders (including Crohn's, ileus or ulcerative colitis, or diverticulitis), or nutrient malabsorption disease (such as celiac disease)
- •Presence of autoimmune disease, metabolic disease, liver disorders, or kidney disorders
- •Diagnosis or treatment of certain cancers in the past 3 years
- •Use of tobacco products or marijuana
- •Daily use of anti-inflammatory drugs
- •Use of antibiotics over the previous 3 months
- •Colonoscopy within a month of the study start date or during the study
- •Use of a carotenoid or isoflavone-containing or metabolism-altering supplement for the last 1 month
- •Use of certain medications (prescription or over-the-counter) that may interfere with the study objectives
- •Unable or unwilling to give informed consent or communicate with study staff
- •Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol
结局指标
主要结局
Interleukin 6
时间窗: Day 99 of the study
Interleukin 6 (IL6) is a blood cytokine and an indicator of inflammatory status. IL6 will be measured to determine how the treatment is affecting inflammatory status. Cytokines are measured in units of pg/mL.
Interleukin 8
时间窗: Day 99 of the study
Interleukin 8 (IL8) is a blood cytokine and an indicator of inflammatory status. IL8 will be measured to determine how the treatment is affecting inflammatory status. Cytokines are measured in units of pg/mL.
Tumor Necrosis Factor Alpha
时间窗: Day 99 of the study
Tumor Necrosis Factor Alpha (TNF-a) is a blood cytokine and an indicator of inflammatory status. TNF-a will be measured to determine how the treatment is affecting inflammatory status. Cytokines are measured in units of pg/mL.
Monocyte chemoattractant protein-1
时间窗: Day 99 of the study
Monocyte chemoattractant protein-1 (MCP-1) is a signalling molecule and is part of the inflammatory process. MCP-1 will be measured to determine how the treatment is affecting inflammatory status. Cytokines are measured in units of pg/mL.
Interferon Gamma
时间窗: Day 99 of the study
Interferon gamma (INF-g) is a signalling molecule and is part of the inflammatory process. INF-g will be measured to determine how the treatment is affecting inflammatory status. Cytokines are measured in units of pg/mL.
次要结局
- Blood HDL cholesterol(Day 1, 15, 43, 71, 99 of the study)
- Blood pressure(Day 1, 15, 43, 71, 99 of the study)
- Flavonoids/Isoflavones will be measured(Days 1, 15, 43, 71, 99 of the study)
- Carotenoids will be measured(Days 1, 15, 43, 71, 99 of the study)
- Identification of metabolites that change in blood and urine by metabolomics(Days 1, 15, 43, 71, 99 of the study)
- Cytokine production by peripheral blood mononuclear cells(Day 1, 15, 43, 71, 99 of the study)
- Blood total cholesterol(Day 1, 15, 43, 71, 99 of the study)
- Blood LDL cholesterol(Day 1, 15, 43, 71, 99 of the study)
- Blood triglycerides(Day 1, 15, 43, 71, 99 of the study)
- Blood glucose(Day 1, 15, 43, 71, 99 of the study)
- High Sensitivity c-Reactive Protein(Day 1, 15, 43, 71, 99 of the study)
- Blood insulin(Day 1, 15, 43, 71, 99 of the study)
研究者
Janet Novotny
Research Physiologist
USDA Beltsville Human Nutrition Research Center