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Completed

NCT Number: NCT03718988

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Stanford, California, 94305, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Meat products

Behavioral

Traditional meat products (beef burger patties, pork sausage, etc.)

Plant Alternative products

Behavioral

Plant-based alternatives (The Beyond Burger, Beyond Sausage, etc.)

Primary outcomes

  1. Trimethylamine N-oxide (TMAO).

    Time frame: Baseline and 8 weeks

    Change from baseline in TMAO at 8 weeks.

Secondary outcomes

  1. Insulin-like Growth Factor-1 (IGF-1)

    Time frame: Baseline and 8 weeks

    Change from baseline in IGF-1 at 8 weeks.

  2. Microbiota composition

    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.

  3. Microbiota function

    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.

  4. Total Cholesterol

    Time frame: Baseline and 8 weeks

    Change from baseline in total cholesterol at 8 weeks of each phase.

  5. LDL Cholesterol

    Time frame: Baseline and 8 weeks

    Change from baseline in LDL cholesterol at 8 weeks of each phase.

  6. HDL Cholesterol

    Time frame: Baseline and 8 weeks

    Change from baseline in HDL cholesterol at 8 weeks of each phase.

  7. Triglycerides

    Time frame: Baseline and 8 weeks

    Change from baseline in triglycerides at 8 weeks of each phase.

  8. Fasting glucose

    Time frame: Baseline and 8 weeks

    Change from baseline in fasting glucose at 8 weeks of each phase.

  9. Fasting insulin

    Time frame: Baseline and 8 weeks

    Change from baseline in fasting insulin at 8 weeks of each phase.

  10. Weight

    Time frame: Baseline and 8 weeks

    Change from baseline in weight at 8 weeks of each phase.

  11. Waist circumference

    Time frame: Baseline and 8 weeks

    Change from baseline in weight at 8 weeks of each phase.

  12. Blood pressure

    Time frame: Baseline and 8 weeks

    Change from baseline in blood pressure at 8 weeks of each phase.

Other outcomes

  1. Satisfaction with Plant Alternative products

    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.

  2. Amount of Plant Alternative product consumption.

    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.

  3. Gastrointestinal symptoms

    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.

  4. Perceived stress

    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.

  5. Perceived cognitive function

    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.

  6. Perceived fatigue

    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.

  7. Perceived overall health

    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.

  8. Perceived well-being

    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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Acronym: SWAP-MEAT

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Oct 25, 2018
Registry last updated
Feb 21, 2023

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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