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Trial record 1 of 1 for:    NCT03718988
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SWAP-MEAT: Study With Appetizing Plant Food - Meat Eating Alternatives Trial (SWAP-MEAT)

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ClinicalTrials.gov Identifier: NCT03718988
Recruitment Status : Completed
First Posted : October 25, 2018
Last Update Posted : September 4, 2020
Sponsor:
Information provided by (Responsible Party):
Christopher Gardner, 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.

Condition or disease Intervention/treatment Phase
Microbiome Immune Function Cardiovascular Diseases Behavioral: Meat products Behavioral: Plant Alternative products Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
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.
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: SWAP-MEAT: Study With Appetizing Plant Food - Meat Eating Alternatives Trial
Actual Study Start Date : January 17, 2019
Actual Primary Completion Date : December 5, 2019
Actual Study Completion Date : December 5, 2019

Arm Intervention/treatment
Experimental: Meat Phase first
Participants will be asked to consume traditional meat products for 8 weeks, then switch to plant-based meat alternative products for another 8 weeks.
Behavioral: Meat products
Traditional meat products (beef burger patties, pork sausage, etc.)

Behavioral: Plant Alternative products
Plant-based alternatives (The Beyond Burger, Beyond Sausage, etc.)

Experimental: Plant Alternative Phase first
Participants will be asked to consume plant-based meat alternative products for 8 weeks, then switch to traditional meat products for another 8 weeks.
Behavioral: Meat products
Traditional meat products (beef burger patties, pork sausage, etc.)

Behavioral: Plant Alternative products
Plant-based alternatives (The Beyond Burger, Beyond Sausage, etc.)




Primary Outcome Measures :
  1. Trimethylamine N-oxide (TMAO). [ Time Frame: Baseline and 8 weeks ]
    Change from baseline in TMAO at 8 weeks.


Secondary Outcome Measures :
  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 Outcome Measures:
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03718988


Locations
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United States, California
Stanford University
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Christopher D. Gardner, PhD Stanford University
  Study Documents (Full-Text)

Documents provided by Christopher Gardner, Stanford University:
Statistical Analysis Plan  [PDF] December 23, 2019

Publications:
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Responsible Party: Christopher Gardner, Professor of Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT03718988    
Other Study ID Numbers: 48285
First Posted: October 25, 2018    Key Record Dates
Last Update Posted: September 4, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cardiovascular Diseases