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
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 1
- 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
- •Age of 18 years to 70 years;
- •Body weight stable (± 3%) for at least three months prior to study commencement;
- •Body mass index (1) between 18.5 and 24.9 (± 0.5) kg/m2 or (2) between 30 and 50 kg/m2 (± 0.5) kg/m2 or waist circumference >88 cm or > 102 cm for females and males, respectively;
- •See below for specific group allocation criteria based on glucose, HbA1c, High density lipoprotein cholesterol (HDL-C), and triglycerides.
- •Fasting blood glucose levels (mmol/L): < 5.6 (Lean-NG and Obese-NG), 5.6-6.9 (Obese-GI), and ≥ 7.0 (Obese-T2D);
- •HbA1c (%): < 5.5 (Lean-NG and Obese-NG), 5.5-6.4 (Obese-GI), and ≥ 6.5 (Obese-T2D);
- •Blood Pressure (mmHg): < 130/85 (Lean-NG and Obese-NG), not required for Obese-GI and Obese-T2D;
- •Triglycerides (mmol/L): < 1.7 (Lean-NG and Obese-NG), not required for Obese-GI and Obese-T2D;
- •HDL-C (mmol/L): ≥ 1.03 for males and ≥ 1.29 for females (Lean-NG and Obese-NG), not required for Obese-GI and Obese-T2D.
排除标准
- •Current or recent history cardiovascular diseases or events (e.g., ischemic, rheumatic, or congenital heart disease, stroke, peripheral vascular disease, heart failure, familial hypercholesterolemia or other monogenic dyslipidemia), use of cardiac implantable electronic devices;
- •Current or recent cancer, including remission, during the last five years;
- •Diseases known to affect the immune system, such as infectious, inflammatory, and autoimmune diseases or autoimmune-related or suspected conditions (e.g., T1D, systemic lupus erythematosus, inflammatory bowel disease), except for psoriasis, atopic dermatitis, and rheumatoid arthritis. Continuous use of anti-inflammatory or immunosuppressant drugs and supplements for which washout is not possible, except for medications which participants with obesity could not refrain from (e.g., baby aspirins);
- •Renal disorders, endocrine disorders other than T2D (e.g., acromegaly, Addison's disease, Cushing's disease);
- •Untreated or uncontrolled thyroid diseases (e.g., Hashimoto's disease, hypothyroidism, hyperthyroidism);
- •Known allergy, aversion to any components of the menu, or restricted dietary patterns (e.g., gluten-free diet, vegetarianism, kosher or halal diets) for which accommodations within the menu are not possible;
- •Participants under titration of their medication or initiating a new treatment or HbA1c >10.5%;
- •Women who are pregnant or plan to become pregnant during the study duration, who are lactating, who have an irregular menstrual cycle or are in perimenopause;
- •Regular use of cannabis (e.g. smoking);
- •Taking part in any other intervention study that might affect the outcomes of the current study.
研究组 & 干预措施
Individuals without obesity and normoglycemia (NG) (Lean-NG)
Experimental
Those assigned to the Lean-NG group will receive a North American-type diet diet for 4 weeks.
干预措施: North American-type diet (Other)
Individuals with obesity and NG (Obese-NG)
Experimental
Those assigned to the Obese-NG group will receive a North American-type diet diet for 4 weeks.
干预措施: North American-type diet (Other)
Individuals with obesity and glucose intolerance (GI) (Obese-GI)
Experimental
Those assigned to the Obese-GI group will receive a North American-type diet diet for 4 weeks.
干预措施: North American-type diet (Other)
Individuals with obesity and type 2 diabetes (T2D) (Obese-T2D)
Experimental
Those assigned to the Obese-T2D group will receive a North American-type diet diet for 4 weeks.
干预措施: North American-type diet (Other)
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 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)
- 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)
- 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 (1)
Loading locations...
相似试验
已完成
不适用
Carbohydrates and Related BiomarkersHealthyOverweightNCT00622661Fred Hutchinson Cancer Center89
已完成
不适用
Glycemic Index, Body Weight and HealthOverweightObesityNCT00324090University of Copenhagen43
尚未招募
不适用
Daily Blood Glucose Trends in Patients at Risk for DiabetesStressCholesterol, ElevatedDiet HabitBlood Sugar HighNCT06000735Karol E. Watson, MD20
已完成
不适用
The Influence of Glycemic Control and Obesity on Energy Balance and Metabolic Flexibility in Type 1 DiabetesType 1 DiabetesNCT03379792AdventHealth Translational Research Institute32
Unknown
不适用
Effect of Nutrition and Lifestyles on Obesity and Chronic Disease in ChinaObesityNCT02509741Chinese PLA General Hospital1,000