SWAP-MEAT: Study With Appetizing Plant Food - Meat Eating Alternatives Trial
- Conditions
- Immune FunctionMicrobiomeCardiovascular Diseases
- Registration Number
- NCT03718988
- Lead Sponsor
- Stanford University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 38
- Age ≥18
- Meat consumption (beef, pork/sausage, chicken) on average ≥ once a day
- Willing to consume meat (beef, pork/sausage, chicken) ≥ 2 times a day
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Weight < 110 lb
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BMI ≥ 40
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LDL-C >190 mg/dL
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Systolic blood pressure (SBP) > 160 mmHg OR Diastolic blood pressure (DBP) > 90 mmHg
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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;
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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.
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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.
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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.
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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.
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Any confirmed or suspected condition/state of immunosuppression or immunodeficiency (primary or acquired) including HIV infection, multiple sclerosis and Graves' disease.
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Regular/frequent use of smoking or chewing tobacco, e-cigarettes, cigars or other nicotine-containing products.
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Regular use of prescription opiate pain medication
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Trimethylamine N-oxide (TMAO). Baseline and 8 weeks Change from baseline in TMAO at 8 weeks.
- Secondary Outcome Measures
Name Time Method Microbiota composition Baseline and 8 weeks Change from baseline in alpha diversity at 8 weeks of each phase. We will be using number of observed sequence variants ("species") determined by standard 16S rRNA amplicon sequencing (V3-V5 region followed by DADA2 to define error-corrected sequence variants) as our primary metric of alpha diversity. Higher alpha diversity is better. The units are the # of sequence variants.
LDL Cholesterol Baseline and 8 weeks Change from baseline in LDL cholesterol at 8 weeks of each phase.
Fasting glucose Baseline and 8 weeks Change from baseline in fasting glucose at 8 weeks of each phase.
Fasting insulin Baseline and 8 weeks Change from baseline in fasting insulin at 8 weeks of each phase.
Total Cholesterol Baseline and 8 weeks Change from baseline in total cholesterol at 8 weeks of each phase.
Weight Baseline and 8 weeks Change from baseline in weight at 8 weeks of each phase.
Blood pressure Baseline and 8 weeks Change from baseline in blood pressure at 8 weeks of each phase.
Waist circumference Baseline and 8 weeks Change from baseline in weight at 8 weeks of each phase.
Insulin-like Growth Factor-1 (IGF-1) Baseline and 8 weeks Change from baseline in IGF-1 at 8 weeks.
Microbiota function Baseline and 8 weeks Change from baseline in composite of short-chain fatty acids (SCFA) concentration (ug/g stool: acetate + propionate + butyrate) at 8 weeks of each phase.
Triglycerides Baseline and 8 weeks Change from baseline in triglycerides at 8 weeks of each phase.
HDL Cholesterol Baseline and 8 weeks Change from baseline in HDL cholesterol at 8 weeks of each phase.
Trial Locations
- Locations (1)
Stanford University
🇺🇸Stanford, California, United States
Stanford University🇺🇸Stanford, California, United States