SWAP-MEAT: Study With Appetizing Plant Food - Meat Eating Alternatives Trial

Not Applicable

Completed

• Conditions: Immune Function; Microbiome; Cardiovascular Diseases
• Interventions: Behavioral: Meat products; Behavioral: Plant Alternative products

• Registration Number: NCT03718988
• Lead Sponsor: Stanford University

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.

Study Timeline

• Study First Submitted: 2018-10-23
• Study First Submitted QC: 2018-10-23
• Study First Posted: 2018-10-25
• Study Start: 2019-01-17
• Primary Completion: 2019-12-05
• Study Completion: 2019-12-05
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-18
• Last Update Posted: 2023-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Meat Phase first	Plant Alternative products	Participants will be asked to consume traditional meat products for 8 weeks, then switch to plant-based meat alternative products for another 8 weeks.
Plant Alternative Phase first	Meat products	Participants will be asked to consume plant-based meat alternative products for 8 weeks, then switch to traditional meat products for another 8 weeks.
Plant Alternative Phase first	Plant Alternative products	Participants will be asked to consume plant-based meat alternative products for 8 weeks, then switch to traditional meat products for another 8 weeks.
Meat Phase first	Meat products	Participants will be asked to consume traditional meat products for 8 weeks, then switch to plant-based meat alternative products for another 8 weeks.

Primary Outcome Measures

Name	Time	Method
Trimethylamine N-oxide (TMAO).	Baseline and 8 weeks	Change from baseline in TMAO at 8 weeks.

Secondary Outcome Measures

Name	Time	Method
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.
LDL Cholesterol	Baseline and 8 weeks	Change from baseline in LDL 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.
Fasting insulin	Baseline and 8 weeks	Change from baseline in fasting insulin at 8 weeks of each phase.
Total Cholesterol	Baseline and 8 weeks	Change from baseline in total cholesterol at 8 weeks of each phase.
Weight	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.
HDL Cholesterol	Baseline and 8 weeks	Change from baseline in HDL cholesterol at 8 weeks of each phase.
Waist circumference	Baseline and 8 weeks	Change from baseline in weight 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 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.
Triglycerides	Baseline and 8 weeks	Change from baseline in triglycerides at 8 weeks of each phase.

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States