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

NCT03718988 | Completed

• 1 other identifier: 48285
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Microbiome; Immune Function; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• Trimethylamine N-oxide (TMAO).

  Change from baseline in TMAO at 8 weeks.

  Baseline and 8 weeks

Secondary Outcomes (12)

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

  Baseline and 8 weeks

• Microbiota composition

  Baseline and 8 weeks

• Microbiota function

  Baseline and 8 weeks

• Total Cholesterol

  Baseline and 8 weeks

• LDL Cholesterol

  Baseline and 8 weeks

Other Outcomes (8)

• Satisfaction with Plant Alternative products

  Baseline and 8 weeks

• Amount of Plant Alternative product consumption.

  Baseline and 8 weeks

• Gastrointestinal symptoms

  Baseline and 8 weeks

Study Arms (2)

Meat Phase first

EXPERIMENTAL

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; Behavioral: Plant Alternative products

Plant Alternative Phase first

EXPERIMENTAL

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; Behavioral: Plant Alternative products

Interventions

Meat products BEHAVIORAL

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

Meat Phase first; Plant Alternative Phase first

Plant Alternative products BEHAVIORAL

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

Meat Phase first; Plant Alternative Phase first

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Related Publications (2)

• 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.

  PMID: 32780794 BACKGROUND

• Ward CP, Landry MJ, Cunanan KM, Raphael KL, Dant CC, Gardner CD, Pao AC. Urinary Response to Consuming Plant-Based Meat Alternatives in Persons with Normal Kidney Function: The SWAP-MEAT Pilot Trial. Clin J Am Soc Nephrol. 2024 Nov 1;19(11):1417-1425. doi: 10.2215/CJN.0000000000000532. Epub 2024 Aug 26.

  PMID: 39514692 DERIVED

Related Links

• Study description and results summary

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Meat Products

Intervention Hierarchy (Ancestors)

Meat; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Christopher D. Gardner, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Model Details: 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.

Study Record Dates

• First Submitted: October 23, 2018
• First Posted: October 25, 2018
• Study Start: January 17, 2019
• Primary Completion: December 5, 2019
• Study Completion: December 5, 2019
• Last Updated: February 21, 2023

Record last verified: 2023-02

Locations

US (1)