Effect of a Nutrient Dense Plant Rich Diet on Glycemic Control in People With Type 2 Diabetes and Obesity
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Glycemic control
研究概览
简要总结
The purpose of this study is to evaluate the effect of a nutrient dense plant rich (NDPR) diet compared to a standard USDA diet on glycemic control, inflammation, and cardiovascular risk in individuals with type 2 diabetes and overweight/obesity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women ages 18-75
- •Type 2 diabetes mellitus diagnosed > 6 months prior to screening visit according to American Diabetes Association criteria
- •HBA1c >7.5% but < 10%
- •BMI >25 kg/m2 ; >23 kg/m2 for Asian subjects but < 45 kg/m2
- •Stable weight (variation < 5 kg within 6 months of screening visit)
- •Ability to give informed consent
- •Ability to follow verbal and written instructions in English
排除标准
- •Active cardiac issues: history of myocardial infarction within 3 months of screening visit, unstable angina pectoris, or Class III or Class IV congestive heart failure
- •Persistent uncontrolled hypertension (BP > 160/100 mmHg on or off antihypertensive medication)
- •Active marijuana or intravenous drug use
- •Recent weight loss (> 5 kg within 6 months of the screening visit)
- •Inflammatory or irritable bowel disease (Crohn's Disease, Ulcerative Colitis, or IBS)
- •Celiac disease
- •Malignancy treated with chemotherapy within the past 1 year
- •Depression or psychosis requiring hospitalization within 1 year, or use of major antipsychotic or tranquilizer drugs (i.e. benzodiazepines)
- •Renal insufficiency (creatinine clearance < 30 ml/min)
- •Transaminases > 2x above the normal range
- •Pregnancy within 6 months of the screening visit
- •History of surgery for the treatment of obesity (gastric banding, gastric bypass, gastric stapling
- •History of alcohol abuse within the past 5 years
- •Vegetarian/Vegan diet
- •Dairy Allergy/Intolerance
- •Anemia, including iron deficient and megaloblastic
- •Vitamin B12 deficiency
- •Leber's disease
研究组 & 干预措施
NDPR diet
Subjects randomized to the nutrient dense plant rich (NDPR) diet will eat foods with high micronutrient density, and favorable glycemic index. The diet is low in saturated fat, high in fiber, and rich in phytochemicals. Total caloric intake will range from 1600-2000/day based on individual needs. Foods include vegetables (30-70% of calories), fruits (15-20% of calories), Beans/Legumes (20-30% of calories), raw nuts and seeds (10-20% of calories), fish or fat-free dairy (twice weekly or less), poultry, eggs and oils (once weekly or less) and limited beef, cheese/milk, processed food and beef.
干预措施: NDPR diet (Other)
USDA diet
Subjects randomized to the healthy U.S.-Style pattern diet will eat the types and proportions of foods Americans typically consume, but in nutrient-dense forms and appropriate amounts. It is designed to meet nutrient needs while not exceeding calorie requirements and while staying within limits for overconsumed dietary components. Total caloric intake will range from 1600-2000/day based on individual needs. Foods include fruits, vegetables (dark green, red/orange, beans, and peas, starchy vegetables), grains (whole grains and refined grains), protein foods (meat, poultry, eggs, seafood, nuts, seeds and soy products), dairy, and oils.
干预措施: USDA healthy eating diet (Other)
结局指标
主要结局
Glycemic control
时间窗: change at 1, 3, 6, 9, 12 months
A1C and finger stick blood sugar levels
次要结局
- hepatic steatosis(baseline, 1, 3, 6, 9, 12 months)
- body composition(change at 1,3,6,9, 12 months)
- quality of life(change at, 1, 3, 6, 9, 12 months)
- body weight(change at 1, 3, 6, 9, 12 months)
- inflammatory markers(change at, 1, 3, 6, 9, 12 months)
研究者
Martin Abrahamson
Principal Investigator
Beth Israel Deaconess Medical Center