Twins Nutrition Study (TwiNS): Vegan vs. Omnivore
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Difference in LDL cholesterol
研究概览
简要总结
This study is designed to investigate the health impact of a vegan diet compared to a usual, omnivorous diet. The investigators plan to study these diets in twins, where one twin follows a vegan diet and the other twin follows an omnivorous diet, thus the investigators control for genetic differences that might impact the effect of the diet.
详细描述
During this study, the investigators will evaluate the nutrient intake in both the vegan and the omnivorous diet. The investigators will also measure physiologic markers of health such as lipid levels, HbA1C, heart rate, and weight, and they will also look at the effect of the diets on the microbiota. In addition to measuring the effect of the diet, the investigators will monitor adherence to the diet, and survey participants on the ease/difficulty in following a vegan diet as well as their energy levels and sense of wellbeing. Thus, this study will help us better understand the health impact and feasibility of following a vegan diet. These results will be of much interest to the general public and the health care professionals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1/2 of a pair of twins that will both be participating
- •Willing to consume a plant-based diet (vegetables, fruit, whole grains, legumes, etc.)
- •Willing to consume meat/eggs (beef, pork/sausage, chicken, eggs) >= 1 time a day
- •Willing to consume dairy (milk, yogurt, cheese) >= 1 time a day
排除标准
- •Weight < 110 lb
- •BMI >= 40
- •LDL-C > 190 mg/dL
- •Systolic Blood Pressure > 160 mmHg OR Diastolic blood pressure > 90 mmHg
- •Pregnant, lactating or planning to become pregnant during the course of the study.
- •Use of any of the following drugs/supplements within the last 2 months:
- •systemic antibiotics, antifungals, antivirals or antiparasitics (intravenous, intramuscular, or oral);
- •corticosteroids (intravenous, intramuscular, oral, nasal or inhaled);
- •cytokines;
- •methotrexate or immunosuppressive cytotoxic agents.
- •Chronic, clinically significant, or unstable (unresolved, requiring on-going changes to medical management or medication) pulmonary, cardiovascular, gastrointestinal, hepatic or renal functional abnormality, as determined by medical history, Type 1 diabetes, dialysis
- •History of active cancer in the past 3 years except for squamous or basal cell carcinomas of the skin that have been medically managed by local excision
- •Unstable dietary history as defined by major changes in diet during the previous month, where the subject has eliminated or significantly increased a major food group in the diet.
- •Recent history of chronic excessive alcohol consumption defined as more than five 1.5-ounce servings of 80 proof distilled spirits, five 12-ounce servings of beer or five 5-ounce servings of wine per day; or > 14 drinks/week.
- •Any confirmed or suspected condition/state of immunosuppression or immunodeficiency (primary or acquired) including HIV infection, multiple sclerosis and Graves' disease.
- •Surgery of the GI tract, with the exception of cholecystectomy and appendectomy, in the past five years. Any major bowel resection at any time.
- •Regular/frequent use of smoking or chewing tobacco, e-cigarettes, cigars or other nicotine-containing products
- •Regular use of prescription opiate pain medication
结局指标
主要结局
Difference in LDL cholesterol
时间窗: Baseline and 8 weeks
Difference in the 8-week change-from-baseline in LDL cholesterol between the vegan vs. omnivore diet groups
次要结局
- Change in inflammatory markers(Baseline and 8 weeks)
- Difference in triglycerides(Baseline and 8 weeks)
- Change in alpha diversity(Baseline and 8 weeks)
研究者
Christopher Gardner
Principal Investigator
Stanford University