Stanford University
Stanford, California, 94305, United States
NCT Number: NCT03718988
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Stanford, California, 94305, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Traditional meat products (beef burger patties, pork sausage, etc.)
Plant-based alternatives (The Beyond Burger, Beyond Sausage, etc.)
Time frame: Baseline and 8 weeks
Change from baseline in TMAO at 8 weeks.
Time frame: Baseline and 8 weeks
Change from baseline in IGF-1 at 8 weeks.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 8 weeks
Change from baseline in total cholesterol at 8 weeks of each phase.
Time frame: Baseline and 8 weeks
Change from baseline in LDL cholesterol at 8 weeks of each phase.
Time frame: Baseline and 8 weeks
Change from baseline in HDL cholesterol at 8 weeks of each phase.
Time frame: Baseline and 8 weeks
Change from baseline in triglycerides at 8 weeks of each phase.
Time frame: Baseline and 8 weeks
Change from baseline in fasting glucose at 8 weeks of each phase.
Time frame: Baseline and 8 weeks
Change from baseline in fasting insulin at 8 weeks of each phase.
Time frame: Baseline and 8 weeks
Change from baseline in weight at 8 weeks of each phase.
Time frame: Baseline and 8 weeks
Change from baseline in weight at 8 weeks of each phase.
Time frame: Baseline and 8 weeks
Change from baseline in blood pressure at 8 weeks of each phase.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 8 weeks
Change from baseline in gastrointestinal symptoms, as assessed by the Gastrointestinal Symptoms Study Questionnaire at 8 weeks of each phase.
Time frame: Baseline and 8 weeks
Change from baseline in perceived stress, as assessed by the PSS-10 questionnaire at 8 weeks of each phase.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Stanford University
Other
Acronym: SWAP-MEAT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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