- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03718988
SWAP-MEAT: Study With Appetizing Plant Food - Meat Eating Alternatives Trial (SWAP-MEAT)
February 18, 2023 updated by: Christopher Gardner, Stanford University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
38
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Stanford, California, United States, 94305
- Stanford University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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.
|
Traditional meat products (beef burger patties, pork sausage, etc.)
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.
|
Traditional meat products (beef burger patties, pork sausage, etc.)
Plant-based alternatives (The Beyond Burger, Beyond Sausage, etc.)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Trimethylamine N-oxide (TMAO).
Time Frame: Baseline and 8 weeks
|
Change from baseline in TMAO at 8 weeks.
|
Baseline and 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Insulin-like Growth Factor-1 (IGF-1)
Time Frame: Baseline and 8 weeks
|
Change from baseline in IGF-1 at 8 weeks.
|
Baseline and 8 weeks
|
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.
|
Baseline and 8 weeks
|
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.
|
Baseline and 8 weeks
|
Total Cholesterol
Time Frame: Baseline and 8 weeks
|
Change from baseline in total cholesterol at 8 weeks of each phase.
|
Baseline and 8 weeks
|
LDL Cholesterol
Time Frame: Baseline and 8 weeks
|
Change from baseline in LDL cholesterol at 8 weeks of each phase.
|
Baseline and 8 weeks
|
HDL Cholesterol
Time Frame: Baseline and 8 weeks
|
Change from baseline in HDL cholesterol at 8 weeks of each phase.
|
Baseline and 8 weeks
|
Triglycerides
Time Frame: Baseline and 8 weeks
|
Change from baseline in triglycerides at 8 weeks of each phase.
|
Baseline and 8 weeks
|
Fasting glucose
Time Frame: Baseline and 8 weeks
|
Change from baseline in fasting glucose at 8 weeks of each phase.
|
Baseline and 8 weeks
|
Fasting insulin
Time Frame: Baseline and 8 weeks
|
Change from baseline in fasting insulin at 8 weeks of each phase.
|
Baseline and 8 weeks
|
Weight
Time Frame: Baseline and 8 weeks
|
Change from baseline in weight at 8 weeks of each phase.
|
Baseline and 8 weeks
|
Waist circumference
Time Frame: Baseline and 8 weeks
|
Change from baseline in weight at 8 weeks of each phase.
|
Baseline and 8 weeks
|
Blood pressure
Time Frame: Baseline and 8 weeks
|
Change from baseline in blood pressure at 8 weeks of each phase.
|
Baseline and 8 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline and 8 weeks
|
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.
|
Baseline and 8 weeks
|
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.
|
Baseline and 8 weeks
|
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.
|
Baseline and 8 weeks
|
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.
|
Baseline and 8 weeks
|
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.
|
Baseline and 8 weeks
|
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.
|
Baseline and 8 weeks
|
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.
|
Baseline and 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Christopher D. Gardner, PhD, Stanford University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 17, 2019
Primary Completion (Actual)
December 5, 2019
Study Completion (Actual)
December 5, 2019
Study Registration Dates
First Submitted
October 23, 2018
First Submitted That Met QC Criteria
October 23, 2018
First Posted (Actual)
October 25, 2018
Study Record Updates
Last Update Posted (Estimate)
February 21, 2023
Last Update Submitted That Met QC Criteria
February 18, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 48285
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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