NCT04291391已完成不适用
The Alberta NutrIMM (Nutrition and Immune Function) Study: Establishing the Importance of Diet and Insulin Resistance in Modulating Immune Function in Obesity
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 2
- 主要终点
- Differences between groups in circulating C-reactive protein (CRP) at Week 4
研究概览
简要总结
This study will investigate the effect of body weight, diet, and high blood sugar levels, under controlled feeding conditions, on immune function in individuals with and without obesity.
This study will be a non-randomized, four-arm parallel group, clinical trial under controlled feeding conditions (4-week nutritional intervention using a North American-type diet). A sample size of n=128 participants will be allocated into one of the following groups:
- Individuals without obesity and normoglycemia (NG) (Lean-NG)
- Individuals with obesity and normoglycemia (Obese-NG)
- Individuals with obesity and glucose intolerance (GI) (Obese-GI)
- Individuals with obesity and type 2 diabetes (T2D) (Obese-T2D)
The following outcomes will be analyzed:
- Immune cell function (ex-vivo cytokine production after stimulation with mitogen and T cell proliferation);
- Immune cell phenotypes;
- Systemic inflammation (C-reactive protein and plasma cytokines);
- Glucose, insulin, glycated hemoglobin (HbA1c), and lipids;
- Fatty acids and phospholipds composition in plasma and red blood cells membrane.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Differences between groups in circulating C-reactive protein (CRP) at Week 4
时间窗: Week 4
CRP will be measured by Alberta Precision Labs using an immunoturbidimetric assay
Differences between groups in IL-2 Secretion by Peripheral Blood Mononuclear Cells (PBMC) After Ex-vivo Stimulation with Phytohemagglutinin (PHA) at Week 4
时间窗: Week 4
PBMCs will be stimulated with PHA for 48h and IL-2 will be quantified using enzyme-linked immunosorbent assay (ELISA).
次要结局
- Change from Baseline in IL-2 Secretion by PBMC After Ex-vivo Stimulation with mitogens at Week 4 and Differences Between Groups at Baseline and Week 4(Baseline and Week 4)
- Change from Baseline in IL-10 Secretion by PBMC After Ex-vivo Stimulation with mitogens at Week 4 and Differences Between Groups at Baseline and Week 4(Baseline and Week 4)
- Change from Baseline in TNF-a Concentrations at Week 4 and Differences Between Groups at Baseline and Week 4.(Baseline and Week 4)
- Change from Baseline in IL-1B Secretion by PBMC After Ex-vivo Stimulation with mitogens at Week 4 and Differences Between Groups at Baseline and Week 4(Baseline and Week 4)
- Change from Baseline in IFN-y Secretion by PBMC After Ex-vivo Stimulation with mitogens at Week 4 and Differences Between Groups at Baseline and Week 4(Baseline and Week 4)
- Change from Baseline in T cell proliferation at Week 4 and Differences Between Groups at Baseline and Week 4(Baseline and Week 4)
- Change from Baseline in T Cells at Week 4 and Differences Between Groups at Baseline and Week 4(Baseline and Week 4)
- Change from Baseline in Circulating Glucose Levels at Week 4 and Differences Between Groups at Baseline and Week 4(Baseline and Week 4)
- Change from Baseline in Circulating Low-Density Lipoprotein Cholesterol Levels at Week 4 and Differences Between Groups at Baseline and Week 4(Baseline and Week 4)
- Change from Baseline in TNF-a Secretion by PBMC After Ex-vivo Stimulation with mitogens at Week 4 and Differences Between Groups at Baseline and Week 4.(Baseline and Week 4)
- Change from Baseline in IL-6 Secretion by PBMC After Ex-vivo Stimulation with mitogens at Week 4 and Differences Between Groups at Baseline and Week 4(Baseline and Week 4)
- Change from Baseline in B Cells at Week 4 and Differences Between Groups at Baseline and Week 4(Baseline and Week 4)
- Change from Baseline in Dendritic Cells at Week 4 and Differences Between Groups at Baseline and Week 4(Baseline and Week 4)
- Change from Baseline in Natural Killer Cells at Week 4 and Differences Between Groups at Baseline and Week 4(Baseline and Week 4)
- Change from Baseline in IL-6 Concentrations at Week 4 and Differences Between Groups at Baseline and Week 4.(Baseline and Week 4)
- Change from Baseline in Circulating Insulin Levels at Week 4 and Differences Between Groups at Baseline and Week 4(Baseline and Week 4)
- Change from Baseline in Circulating Triglycerides Levels at Week 4 and Differences Between Groups at Baseline and Week 4(Baseline and Week 4)
- Change from Baseline in Phospholipids Classes Quantifications in Red Blood Cells at Week 4 and Differences Between Groups at Baseline and Week 4.(Baseline and Week 4)
- Change from Baseline in Monocytes at Week 4 and Differences Between Groups at Baseline and Week 4(Baseline and Week 4)
- Change from Baseline in Complete Blood Cell Count and Differential at Week 4 and Differences Between Groups at Baseline and Week 4(Baseline and Week 4)
- Change from Baseline in Circulating Hemoglobin A1c Levels at Week 4 and Differences Between Groups at Baseline and Week 4(Baseline and Week 4)
- Differences Between Groups at Week 4 in Circulating Glucose Levels before and after an Oral Glucose Tolerance Test(Week 4)
- Change from Baseline in Total Lipids Fatty Acids Composition in Plasma and Red Blood Cells at Week 4 and Differences Between Groups at Baseline and Week 4(Baseline and Week 4)
- Change from Baseline in Circulating Total Cholesterol Levels at Week 4 and Differences Between Groups at Baseline and Week 4(Baseline and Week 4)
- Change from Baseline in Phospholipids Fatty Acids Composition in Red Blood Cells at Week 4 and Differences Between Groups at Baseline and Week 4.(Baseline and Week 4)
- Change from Baseline in Circulating High-Density Lipoprotein Cholesterol Levels at Week 4 and Differences Between Groups at Baseline and Week 4(Baseline and Week 4)
- Change from Baseline in Circulating Non-High Density Lipoprotein Cholesterol Levels at Week 4 and Differences Between Groups at Baseline and Week 4(Baseline and Week 4)
研究者
研究点 (2)
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