Clinical trial NCT03718988: SWAP-MEAT: Study With Appetizing Plant Food - Meat Eating Alternatives Trial
Official title: SWAP-MEAT: Study With Appetizing Plant Food - Meat Eating Alternatives Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Microbiome
Immune Function
Cardiovascular Diseases
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2018-10-25
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Trimethylamine N-oxide (TMAO).
timeFrame: Baseline and 8 weeks
Secondary outcomes:
measure: Insulin-like Growth Factor-1 (IGF-1)
timeFrame: Baseline and 8 weeks
measure: Microbiota composition
timeFrame: Baseline and 8 weeks
measure: Microbiota function
timeFrame: Baseline and 8 weeks
measure: Total Cholesterol
timeFrame: Baseline and 8 weeks
measure: LDL Cholesterol
timeFrame: Baseline and 8 weeks
measure: HDL Cholesterol
timeFrame: Baseline and 8 weeks
measure: Triglycerides
timeFrame: Baseline and 8 weeks
measure: Fasting glucose
timeFrame: Baseline and 8 weeks
measure: Fasting insulin
timeFrame: Baseline and 8 weeks
measure: Weight
timeFrame: Baseline and 8 weeks
measure: Waist circumference
timeFrame: Baseline and 8 weeks
measure: Blood pressure
timeFrame: Baseline and 8 weeks
Other outcomes:
measure: Satisfaction with Plant Alternative products
timeFrame: Baseline and 8 weeks
measure: Amount of Plant Alternative product consumption.
timeFrame: Baseline and 8 weeks
measure: Gastrointestinal symptoms
timeFrame: Baseline and 8 weeks
measure: Perceived stress
timeFrame: Baseline and 8 weeks
measure: Perceived cognitive function
timeFrame: Baseline and 8 weeks
measure: Perceived fatigue
timeFrame: Baseline and 8 weeks
measure: Perceived overall health
timeFrame: Baseline and 8 weeks
measure: Perceived well-being
timeFrame: Baseline and 8 weeks
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Christopher D. Gardner, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.