Cardiovascular Diseases, Immune Function, Microbiome
Conditions
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.
Interventions
BEHAVIORALMeat products
Traditional meat products (beef burger patties, pork sausage, etc.)
BEHAVIORALPlant Alternative products
Plant-based alternatives (The Beyond Burger, Beyond Sausage, etc.)
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
SWAP-MEAT is a randomized, cross-over design among 30 adults randomly assigned to one of two diet sequences. Each diet sequence will consist of two phases: the Meat phase, which will consist of participants consuming their typical diet, and the Plant Alternative phase, which will consist of participants consuming plant-based meat alternatives instead of their typical meat products, for a predominantly vegetarian diet.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* Weight \< 110 lb * BMI ≥ 40 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Trimethylamine N-oxide (TMAO). | Baseline and 8 weeks | Change from baseline in TMAO at 8 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Triglycerides | Baseline and 8 weeks | Change from baseline in triglycerides 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 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. |
| 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. |
| Total Cholesterol | Baseline and 8 weeks | Change from baseline in total cholesterol at 8 weeks of each phase. |
| LDL Cholesterol | Baseline and 8 weeks | Change from baseline in LDL cholesterol at 8 weeks of each phase. |
| Weight | Baseline and 8 weeks | Change from baseline in weight at 8 weeks of each phase. |
| Waist circumference | 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. |
| Fasting insulin | Baseline and 8 weeks | Change from baseline in fasting insulin at 8 weeks of each phase. |
| HDL Cholesterol | Baseline and 8 weeks | Change from baseline in HDL 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Gastrointestinal symptoms | Baseline and 8 weeks | Change from baseline in gastrointestinal symptoms, as assessed by the Gastrointestinal Symptoms Study Questionnaire at 8 weeks of each phase. |
| Perceived stress | Baseline and 8 weeks | Change from baseline in perceived stress, as assessed by the PSS-10 questionnaire at 8 weeks of each phase. |
| Perceived cognitive function | Baseline and 8 weeks | Change from baseline in perceived cognitive function, as assessed by the PROMIS SF v2.0 - Cognitive Function Abilities 4a and PROMIS SF v2.0 - Cognitive Function 4a questionnaires at 8 weeks of each phase. |
| Perceived fatigue | Baseline and 8 weeks | Change from baseline in perceived fatigue, as assessed by the PROMIS SF v1.0 - Fatigue-4a questionnaire at 8 weeks of each phase. |
| Perceived overall health | Baseline and 8 weeks | Change from baseline in perceived overall health, as assessed by the PROMIS Scale v1.2-Global Health questionnaire at 8 weeks of each phase. |
| Perceived well-being | Baseline and 8 weeks | Change from baseline in perceived well-being, as assessed by the WHO Well-Being Index questionnaire at 8 weeks of each phase. |
| Satisfaction with Plant Alternative products | Baseline and 8 weeks | Average satisfaction level with meals at 8 weeks of each phase (Meat phase compared to Plant Alternative phase) using a Likert scale. |
| Amount of Plant Alternative product consumption. | Baseline and 8 weeks | Average number of daily servings of traditional meat products in Meat phase compared to average number of daily servings of Plant Alternative products in Plant Alternative phase. |
Countries
United States
Outcome results
None listed