SWAP-MEAT: Study With Appetizing Plant Food - Meat Eating Alternatives Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Trimethylamine N-oxide (TMAO).
研究概览
简要总结
This study aims to investigate the impact of replacing meat consumption with plant-based meat alternative consumption on cardiovascular health, the gut microbiome, and metabolic status.
详细描述
Plant-based meat alternatives that closely emulate animal protein provide a new opportunity to decrease meat consumption worldwide. Decreasing meat consumption and shifting to a plant-based diet has been linked to improvements in physical health, including decreased risk of cardiovascular disease, metabolic syndrome, and type 2 diabetes (Kahleova, Levin, & Barnard, 2017). However, the extent to which plant-based meat alternatives specifically can modulate biomarkers of physical health, particularly TMAO and IGF-1, and the gut microbiome remain relatively unexplored. It is also largely unknown to what extent consumers can feasibly and sustainably exchange meat products for plant-based meat alternatives for extended periods of time. Plant-based meat alternatives offer a promising way to support consumers' shift to a plant-based diet, and in turn, to potentially improve levels of TMAO and IGF-1 and decrease cardiovascular risk. Thus, the investigators hypothesize that consumer levels of TMAO and IGF-1 will be improved after 8 weeks of consuming plant-based meat alternative products, as compared to 8 weeks of consuming traditional meat products.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
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
- •Meat consumption (beef, pork/sausage, chicken) on average ≥ once a day
- •Willing to consume meat (beef, pork/sausage, chicken) ≥ 2 times a day
排除标准
- •Weight < 110 lb
- •LDL-C >190 mg/dL
- •Systolic blood pressure (SBP) > 160 mmHg OR Diastolic blood pressure (DBP) > 90 mmHg
- •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.
- •Regular/frequent use of smoking or chewing tobacco, e-cigarettes, cigars or other nicotine-containing products.
- •Regular use of prescription opiate pain medication
研究组 & 干预措施
Meat Phase first
Participants will be asked to consume traditional meat products for 8 weeks, then switch to plant-based meat alternative products for another 8 weeks.
干预措施: Meat products (Behavioral)
Meat Phase first
Participants will be asked to consume traditional meat products for 8 weeks, then switch to plant-based meat alternative products for another 8 weeks.
干预措施: Plant Alternative products (Behavioral)
Plant Alternative Phase first
Participants will be asked to consume plant-based meat alternative products for 8 weeks, then switch to traditional meat products for another 8 weeks.
干预措施: Meat products (Behavioral)
Plant Alternative Phase first
Participants will be asked to consume plant-based meat alternative products for 8 weeks, then switch to traditional meat products for another 8 weeks.
干预措施: Plant Alternative products (Behavioral)
结局指标
主要结局
Trimethylamine N-oxide (TMAO).
时间窗: Baseline and 8 weeks
Change from baseline in TMAO at 8 weeks.
次要结局
- Microbiota composition(Baseline and 8 weeks)
- LDL Cholesterol(Baseline and 8 weeks)
- Fasting glucose(Baseline and 8 weeks)
- Fasting insulin(Baseline and 8 weeks)
- Total Cholesterol(Baseline and 8 weeks)
- Weight(Baseline and 8 weeks)
- Blood pressure(Baseline and 8 weeks)
- HDL Cholesterol(Baseline and 8 weeks)
- Waist circumference(Baseline and 8 weeks)
- Insulin-like Growth Factor-1 (IGF-1)(Baseline and 8 weeks)
- Microbiota function(Baseline and 8 weeks)
- Triglycerides(Baseline and 8 weeks)
研究者
Christopher Gardner
Professor of Medicine
Stanford University