Cardiovascular Diseases Clinical Trial
— SWAP-MEATOfficial title:
SWAP-MEAT: Study With Appetizing Plant Food - Meat Eating Alternatives Trial
NCT number | NCT03718988 |
Other study ID # | 48285 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 17, 2019 |
Est. completion date | December 5, 2019 |
Verified date | February 2023 |
Source | Stanford University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 38 |
Est. completion date | December 5, 2019 |
Est. primary completion date | December 5, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Stanford University | Stanford | California |
Lead Sponsor | Collaborator |
---|---|
Stanford University |
United States,
Crimarco A, Springfield S, Petlura C, Streaty T, Cunanan K, Lee J, Fielding-Singh P, Carter MM, Topf MA, Wastyk HC, Sonnenburg ED, Sonnenburg JL, Gardner CD. A randomized crossover trial on the effect of plant-based compared with animal-based meat on trimethylamine-N-oxide and cardiovascular disease risk factors in generally healthy adults: Study With Appetizing Plantfood-Meat Eating Alternative Trial (SWAP-MEAT). Am J Clin Nutr. 2020 Nov 11;112(5):1188-1199. doi: 10.1093/ajcn/nqaa203. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Satisfaction with Plant Alternative products | Average satisfaction level with meals at 8 weeks of each phase (Meat phase compared to Plant Alternative phase) using a Likert scale. | Baseline and 8 weeks | |
Other | Amount of Plant Alternative product consumption. | 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. | Baseline and 8 weeks | |
Other | Gastrointestinal symptoms | Change from baseline in gastrointestinal symptoms, as assessed by the Gastrointestinal Symptoms Study Questionnaire at 8 weeks of each phase. | Baseline and 8 weeks | |
Other | Perceived stress | Change from baseline in perceived stress, as assessed by the PSS-10 questionnaire at 8 weeks of each phase. | Baseline and 8 weeks | |
Other | Perceived cognitive function | 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. | Baseline and 8 weeks | |
Other | Perceived fatigue | Change from baseline in perceived fatigue, as assessed by the PROMIS SF v1.0 - Fatigue-4a questionnaire at 8 weeks of each phase. | Baseline and 8 weeks | |
Other | Perceived overall health | Change from baseline in perceived overall health, as assessed by the PROMIS Scale v1.2-Global Health questionnaire at 8 weeks of each phase. | Baseline and 8 weeks | |
Other | Perceived well-being | Change from baseline in perceived well-being, as assessed by the WHO Well-Being Index questionnaire at 8 weeks of each phase. | Baseline and 8 weeks | |
Primary | Trimethylamine N-oxide (TMAO). | Change from baseline in TMAO at 8 weeks. | Baseline and 8 weeks | |
Secondary | Insulin-like Growth Factor-1 (IGF-1) | Change from baseline in IGF-1 at 8 weeks. | Baseline and 8 weeks | |
Secondary | Microbiota composition | 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. | Baseline and 8 weeks | |
Secondary | Microbiota function | Change from baseline in composite of short-chain fatty acids (SCFA) concentration (ug/g stool: acetate + propionate + butyrate) at 8 weeks of each phase. | Baseline and 8 weeks | |
Secondary | Total Cholesterol | Change from baseline in total cholesterol at 8 weeks of each phase. | Baseline and 8 weeks | |
Secondary | LDL Cholesterol | Change from baseline in LDL cholesterol at 8 weeks of each phase. | Baseline and 8 weeks | |
Secondary | HDL Cholesterol | Change from baseline in HDL cholesterol at 8 weeks of each phase. | Baseline and 8 weeks | |
Secondary | Triglycerides | Change from baseline in triglycerides at 8 weeks of each phase. | Baseline and 8 weeks | |
Secondary | Fasting glucose | Change from baseline in fasting glucose at 8 weeks of each phase. | Baseline and 8 weeks | |
Secondary | Fasting insulin | Change from baseline in fasting insulin at 8 weeks of each phase. | Baseline and 8 weeks | |
Secondary | Weight | Change from baseline in weight at 8 weeks of each phase. | Baseline and 8 weeks | |
Secondary | Waist circumference | Change from baseline in weight at 8 weeks of each phase. | Baseline and 8 weeks | |
Secondary | Blood pressure | Change from baseline in blood pressure at 8 weeks of each phase. | Baseline and 8 weeks |
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