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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date February 2023
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Meat products
Traditional meat products (beef burger patties, pork sausage, etc.)
Plant Alternative products
Plant-based alternatives (The Beyond Burger, Beyond Sausage, etc.)

Locations

Country Name City State
United States Stanford University Stanford California

Sponsors (1)

Lead Sponsor Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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

Outcome

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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