Cardiometabolic Risk FactorsNCT05071196
Facilitated Vegan Diet on Cardiometabolic Endpoints and Trimethylamine N-oxide
A study testing Facilitated Vegan Diet and Omnivorous Diet in people with Cardiometabolic Risk Factors, run by David Grant U.S. Air Force Medical Center at 1 site in United States.
Trial summary
Vegan meal kit delivery offers consumer convenience and has shown benefit in cardiometabolic parameters such as low-density lipoprotein cholesterol (LDL-c) and weight. The purpose of this study is to evaluate the impact of meal kit facilitated vegan diet on LDL-c and trimethylamine N-oxide (TMAO) when compared to an… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiometabolic Risk Factors
- What is being tested?
- Facilitated Vegan Diet and Omnivorous Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2022to 1 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old
- BMI ≥ 25kg/m^2
- Consume ≥ 5 servings red meat per week
- Active duty military and Department of Defense (DoD) Beneficiaries with active Tricare insurance
- Willing and able to adopt a vegan or standard omnivorous diet for 4 weeks
- Willing and able to track meal patterns, nutritional intake, exercise activity, and adverse events for 13 weeks
- Willing and able to come to David Grant USAF Medical Center for 4 blood draws
- Able to receive weekly emails and receive and prepare meal kits
Who cannot join
- Currently on a vegetarian, vegan, or food-group restricted diet
- Currently taking or planning to initiate medications or supplements that significantly affect TMAO levels, carnitine, choline, or gut microbiome (Systemic antibiotics, antifungals, antivirals, antiparasitic, corticosteroids, methotrexate, cytokines, or immunosuppressive cytotoxic agents, laxatives, proton pump inhibitors, resveratrol, meldonium, or metformin)
- Currently consuming the following ≥ 2 times per week: probiotics/prebiotics, probiotic enhanced foods (eg. enhanced yogurt, kefir, kombucha), or energy drinks, multivitamins, or supplements with choline, carnitine, or betaine (Acceptable to consume: non-probiotic enhanced yogurts, energy drinks and multivitamins without choline, carnitine, or betaine)
- Participants will have the option to delay study start if they express interest in the study and have permanently discontinued one of the excluded diet, medication, or supplement listed previously within the past 4 weeks (minimum 4 week time between discontinuation of excluded item and study start)
- Clinically significant or unstable cardiovascular, gastrointestinal, hepatic, or renal disease states defined as requiring on-going changes to medication or medical management
- Consumption of smoking or chewing tobacco, or other nicotine-containing products for >1 day per week
- Consumption of >14 alcohol drinks per week
- Pregnant, breastfeeding, or plan to become pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
David Grant U.S. Air Force Medical Center
Travis Air Force Base, California, 94535
About this study
Official title: Impact of Facilitated Vegan Diet on Cardiometabolic Endpoints and Trimethylamine N-oxide
Vegan meal kit delivery offers consumer convenience and has shown benefit in cardiometabolic parameters such as low-density lipoprotein cholesterol (LDL-c) and weight. The purpose of this study is to evaluate the impact of meal kit facilitated vegan diet on LDL-c and trimethylamine N-oxide (TMAO) when compared to an omnivorous diet control.
Read the detailed description
This study will compare the impact of a vegan diet to a non-vegan diet, when provided with meal kits in participants who are overweight.
A vegan diet includes foods that come from plants and excludes foods that come from animals like meat, dairy, and eggs. Dietary modifications such as adopting a vegan diet are associated with significant improvements in cardiometabolic parameters, making it one of the preferred treatment options for obesity and preventing associated health conditions. Meal kits are packages that include: a quick (~30-45 minutes) and simple recipe, all the recipe's required ingredients, and are conveniently delivered to patient homes. In this study, a facilitated vegan diet is defined as a change from an omnivorous diet to a vegan diet with the aid of boxed vegan meal kit delivery. A facilitated vegan diet has shown LDL-c and weight improvements over continuing an omnivorous diet in a preliminary study.
TMAO, changes in gut microbiome, and compliance to dietary modification impact cardiovascular and overall health. TMAO is a diet dependent biomarker for CVD, as elevated TMAO levels are associated with a 62% increased risk of heart attack, stroke, or death. TMAO increases platelet hyperactivity, inflammation, and foam cell generation, all of which contribute to atherosclerosis and may explain the increased risk of CVD. Additionally, TMAO predicts risk of major adverse cardiovascular events independently of other cardiovascular risk factors.
Consumption of animal products elevate TMAO levels due to its abundance of TMAO precursors: choline and carnitine. Chronic dietary red meat was associated with increased TMAO levels over white meat and non-meat protein. One study found that consuming plant-based alternative meat products improved TMAO levels over a mostly red meat diet. Both study interventions replaced protein sources but did not remove animal products such as eggs and dairy, which have conflicting evidence relative to TMAO. This study intervention will have participants adopt a full vegan diet, eliminating animal products.
The gut microbiome plays a crucial role in converting dietary precursors into TMAO. TMAO levels post l-carnitine ingestion were significantly higher in patients on a long-term omnivorous diet vs patients on a long-term vegan or vegetarian diet. This suggests that the gut microbiome in a plant-based diet lowers the formation of TMAO via the diet. This study will explore changes in gut microbiome from a dietary intervention in relation to TMAO and explore if these changes are sustained after discontinuing a 4-week facilitated vegan diet. Additionally, changes in gut microbiome will be explored in relation to microbiota changes seen in other disease states such as anxiety, irritable bowel disease, and other inflammatory diseases.
The impact of dietary modifications on controlling obesity and associated health conditions has room for improvement. Dietary modifications have long been one of the preferred treatments in obesity and CVD prevention, yet the obesity rates continue to rise. One potential area of improvement is compliance to dietary modification. This study will explore changes in food group restricted free diet patterns after a 4-week vegan meal kit intervention.
- Conditions
- Cardiometabolic Risk Factors
- Being tested
- Facilitated Vegan Diet, Omnivorous Diet
- Keywords
- Vegan, boxed meal kit, trimethylamine N-oxide, cardiometabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Facilitated Vegan DietOther
Vegan boxed meal kits
Omnivorous DietOther
Non-vegan boxed meal kits
| Study group | Role | What they receive |
|---|---|---|
| Facilitated Vegan Diet | Experimental | The facilitated vegan participants will self-prepare and consume 2 vegan meal kits per day for 4 weeks Receives: Other: Facilitated Vegan Diet |
| Standard Omnivorous Diet | Active comparator | The standard omnivorous arm will self-prepare and consume 2 non-vegan meal kits per day for 4 weeks Receives: Other: Omnivorous Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change between intervention arms in baseline adjusted LDL-c at 4 weeks
Change in LDL-c
Measured: 4 weeks
Change between intervention arms in baseline adjusted TMAO at 4 weeks
Change in TMAO
Measured: 4 weeks
Secondary outcomes (16)
Change between intervention arms in baseline adjusted LDL-c at 8 weeks
Change in LDL-c
Measured: 8 weeks
Change between intervention arms in baseline adjusted LDL-c at 12 weeks
Change in LDL-c
Measured: 12 weeks
Change between intervention arms in baseline adjusted TMAO at 8 weeks
Change in TMAO
Measured: 8 weeks
Change between intervention arms in baseline adjusted TMAO at 12 weeks
Change in TMAO
Measured: 12 weeks
Change between intervention arms in baseline adjusted lipid panel parameters at 4 weeks
Change in lipid panel
Measured: 4 weeks
Change between intervention arms in baseline adjusted lipid panel parameters at 8 weeks
Change in lipid panel
Measured: 8 weeks
Change between intervention arms in baseline adjusted lipid panel parameters at 12 weeks
Change in lipid panel
Measured: 12 weeks
Change between intervention arms in baseline adjusted BMI at 4 weeks
Weight and height will be combined to report BMI in kg/m^2
Measured: 4 weeks
Change between intervention arms in baseline adjusted BMI at 8 weeks
Weight and height will be combined to report BMI in kg/m^2
Measured: 8 weeks
Change between intervention arms in baseline adjusted BMI at 12 weeks
Weight and height will be combined to report BMI in kg/m^2
Measured: 12 weeks
Change between intervention arms in baseline adjusted blood pressure at 4 weeks
Measured with Sphygmocor device, both systolic and diastolic blood pressures
Measured: 4 weeks
Change between intervention arms in baseline adjusted blood pressure at 8 weeks
Measured with Sphygmocor device, both systolic and diastolic blood pressures
Measured: 8 weeks
Change between intervention arms in baseline adjusted blood pressure at 12 weeks
Measured with Sphygmocor device, both systolic and diastolic blood pressures
Measured: 12 weeks
Change between intervention arms in baseline adjusted hemoglobin A1c at 4 weeks
Change in hemoglobin A1c
Measured: 4 weeks
Change between intervention arms in baseline adjusted hemoglobin A1c at 8 weeks
Change in hemoglobin A1c
Measured: 8 weeks
Change between intervention arms in baseline adjusted hemoglobin A1c at 12 weeks
Change in hemoglobin A1c
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2021
- Study start1 Jan 2022
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Cardiometabolic Risk FactorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, controlled, prospective clinical trial
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- David Grant U.S. Air Force Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Kevin Pham, David Grant U.S. Air Force Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05071196
- Sponsor's protocol ID
- FWH20210097H
- Status last verified
- Mar 2022
- First submitted
- 2 Sep 2021
- Last updated
- 1 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
The Vegan Diet. National Health Service website. Updated Aug 2018. Accessed 10 Jan 2021.
Najjar RS, Moore CE, Montgomery BD. A defined, plant-based diet utilized in an outpatient cardiovascular clinic effectively treats hypercholesterolemia and hypertension and reduces medications. Clin Cardiol. 2018 Mar;41(3):307-313. doi: 10.1002/clc.22863. Epub 2018 Mar 25.
PubMed 29575002Heianza Y, Ma W, Manson JE, Rexrode KM, Qi L. Gut Microbiota Metabolites and Risk of Major Adverse Cardiovascular Disease Events and Death: A Systematic Review and Meta-Analysis of Prospective Studies. J Am Heart Assoc. 2017 Jun 29;6(7):e004947. doi: 10.1161/JAHA.116.004947.
PubMed 28663251Tang WH, Wang Z, Levison BS, Koeth RA, Britt EB, Fu X, Wu Y, Hazen SL. Intestinal microbial metabolism of phosphatidylcholine and cardiovascular risk. N Engl J Med. 2013 Apr 25;368(17):1575-84. doi: 10.1056/NEJMoa1109400.
PubMed 23614584Wang Z, Bergeron N, Levison BS, Li XS, Chiu S, Jia X, Koeth RA, Li L, Wu Y, Tang WHW, Krauss RM, Hazen SL. Impact of chronic dietary red meat, white meat, or non-meat protein on trimethylamine N-oxide metabolism and renal excretion in healthy men and women. Eur Heart J. 2019 Feb 14;40(7):583-594. doi: 10.1093/eurheartj/ehy799.
PubMed 30535398Crimarco 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.
PubMed 32780794Koeth RA, Wang Z, Levison BS, Buffa JA, Org E, Sheehy BT, Britt EB, Fu X, Wu Y, Li L, Smith JD, DiDonato JA, Chen J, Li H, Wu GD, Lewis JD, Warrier M, Brown JM, Krauss RM, Tang WH, Bushman FD, Lusis AJ, Hazen SL. Intestinal microbiota metabolism of L-carnitine, a nutrient in red meat, promotes atherosclerosis. Nat Med. 2013 May;19(5):576-85. doi: 10.1038/nm.3145. Epub 2013 Apr 7.
PubMed 23563705
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Facilitated Vegan Diet on Cardiometabolic Endpoints and Trimethylamine N-oxide
- ClinicalTrials.gov ID
- NCT05071196
- Acronym / sponsor ID
- FWH20210097H
- Conditions
- Cardiometabolic Risk Factors
- Keywords
- Vegan, boxed meal kit, trimethylamine N-oxide, cardiometabolic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- David Grant U.S. Air Force Medical CenterUS federal agency
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 8 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Vegan meal kit delivery offers consumer convenience and has shown benefit in cardiometabolic parameters such as low-density lipoprotein cholesterol (LDL-c) and weight. The purpose of this study is to evaluate the impact of meal kit facilitated vegan diet on LDL-c and trimethylamine N-oxide (TMAO) when compared to an omnivorous diet control.
Detailed description
This study will compare the impact of a vegan diet to a non-vegan diet, when provided with meal kits in participants who are overweight.
A vegan diet includes foods that come from plants and excludes foods that come from animals like meat, dairy, and eggs. Dietary modifications such as adopting a vegan diet are associated with significant improvements in cardiometabolic parameters, making it one of the preferred treatment options for obesity and preventing associated health conditions. Meal kits are packages that include: a quick (~30-45 minutes) and simple recipe, all the recipe's required ingredients, and are conveniently delivered to patient homes. In this study, a facilitated vegan diet is defined as a change from an omnivorous diet to a vegan diet with the aid of boxed vegan meal kit delivery. A facilitated vegan diet has shown LDL-c and weight improvements over continuing an omnivorous diet in a preliminary study.
TMAO, changes in gut microbiome, and compliance to dietary modification impact cardiovascular and overall health. TMAO is a diet dependent biomarker for CVD, as elevated TMAO levels are associated with a 62% increased risk of heart attack, stroke, or death. TMAO increases platelet hyperactivity, inflammation, and foam cell generation, all of which contribute to atherosclerosis and may explain the increased risk of CVD. Additionally, TMAO predicts risk of major adverse cardiovascular events independently of other cardiovascular risk factors.
Consumption of animal products elevate TMAO levels due to its abundance of TMAO precursors: choline and carnitine. Chronic dietary red meat was associated with increased TMAO levels over white meat and non-meat protein. One study found that consuming plant-based alternative meat products improved TMAO levels over a mostly red meat diet. Both study interventions replaced protein sources but did not remove animal products such as eggs and dairy, which have conflicting evidence relative to TMAO. This study intervention will have participants adopt a full vegan diet, eliminating animal products.
The gut microbiome plays a crucial role in converting dietary precursors into TMAO. TMAO levels post l-carnitine ingestion were significantly higher in patients on a long-term omnivorous diet vs patients on a long-term vegan or vegetarian diet. This suggests that the gut microbiome in a plant-based diet lowers the formation of TMAO via the diet. This study will explore changes in gut microbiome from a dietary intervention in relation to TMAO and explore if these changes are sustained after discontinuing a 4-week facilitated vegan diet. Additionally, changes in gut microbiome will be explored in relation to microbiota changes seen in other disease states such as anxiety, irritable bowel disease, and other inflammatory diseases.
The impact of dietary modifications on controlling obesity and associated health conditions has room for improvement. Dietary modifications have long been one of the preferred treatments in obesity and CVD prevention, yet the obesity rates continue to rise. One potential area of improvement is compliance to dietary modification. This study will explore changes in food group restricted free diet patterns after a 4-week vegan meal kit intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, controlled, prospective clinical trial
| Arm | Type | Receives |
|---|---|---|
| Facilitated Vegan Diet | Experimental | Other: Facilitated Vegan DietThe facilitated vegan participants will self-prepare and consume 2 vegan meal kits per day for 4 weeks |
| Standard Omnivorous Diet | Active comparator | Other: Omnivorous DietThe standard omnivorous arm will self-prepare and consume 2 non-vegan meal kits per day for 4 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18 years old
- BMI ≥ 25kg/m^2
- Consume ≥ 5 servings red meat per week
- Active duty military and Department of Defense (DoD) Beneficiaries with active Tricare insurance
- Willing and able to adopt a vegan or standard omnivorous diet for 4 weeks
Key exclusion criteria (8 listed)
- Currently on a vegetarian, vegan, or food-group restricted diet
- Currently taking or planning to initiate medications or supplements that significantly affect TMAO levels, carnitine, choline, or gut microbiome (Systemic antibiotics, antifungals, antivirals, antiparasitic, corticosteroids, methotrexate, cytokines, or immunosuppressive cytotoxic agents, laxatives, proton pump inhibitors, resveratrol, meldonium, or metformin)
- Currently consuming the following ≥ 2 times per week: probiotics/prebiotics, probiotic enhanced foods (eg. enhanced yogurt, kefir, kombucha), or energy drinks, multivitamins, or supplements with choline, carnitine, or betaine (Acceptable to consume: non-probiotic enhanced yogurts, energy drinks and multivitamins without choline, carnitine, or betaine)
- Participants will have the option to delay study start if they express interest in the study and have permanently discontinued one of the excluded diet, medication, or supplement listed previously within the past 4 weeks (minimum 4 week time between discontinuation of excluded item and study start)
- Clinically significant or unstable cardiovascular, gastrointestinal, hepatic, or renal disease states defined as requiring on-going changes to medication or medical management
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Facilitated Vegan DietVegan boxed meal kits | Other | Facilitated Vegan Diet |
| Omnivorous DietNon-vegan boxed meal kits | Other | Standard Omnivorous Diet |
Primary outcome
Change between intervention arms in baseline adjusted LDL-c at 4 weeks
Time frame: 4 weeks
Change in LDL-c
Change between intervention arms in baseline adjusted TMAO at 4 weeks
Time frame: 4 weeks
Change in TMAO
16 secondary outcomes
Change between intervention arms in baseline adjusted LDL-c at 8 weeks
Time frame: 8 weeks
Change between intervention arms in baseline adjusted LDL-c at 12 weeks
Time frame: 12 weeks
Change between intervention arms in baseline adjusted TMAO at 8 weeks
Time frame: 8 weeks
Change between intervention arms in baseline adjusted TMAO at 12 weeks
Time frame: 12 weeks
Change between intervention arms in baseline adjusted lipid panel parameters at 4 weeks
Time frame: 4 weeks
Change between intervention arms in baseline adjusted lipid panel parameters at 8 weeks
Time frame: 8 weeks
Change between intervention arms in baseline adjusted lipid panel parameters at 12 weeks
Time frame: 12 weeks
Change between intervention arms in baseline adjusted BMI at 4 weeks
Time frame: 4 weeks
Change between intervention arms in baseline adjusted BMI at 8 weeks
Time frame: 8 weeks
Change between intervention arms in baseline adjusted BMI at 12 weeks
Time frame: 12 weeks
Change between intervention arms in baseline adjusted blood pressure at 4 weeks
Time frame: 4 weeks
Change between intervention arms in baseline adjusted blood pressure at 8 weeks
Time frame: 8 weeks
Change between intervention arms in baseline adjusted blood pressure at 12 weeks
Time frame: 12 weeks
Change between intervention arms in baseline adjusted hemoglobin A1c at 4 weeks
Time frame: 4 weeks
Change between intervention arms in baseline adjusted hemoglobin A1c at 8 weeks
Time frame: 8 weeks
Change between intervention arms in baseline adjusted hemoglobin A1c at 12 weeks
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2022.
- BackgroundThe Vegan Diet. National Health Service website. Updated Aug 2018. Accessed 10 Jan 2021.
- Background: PubMed 29575002Najjar RS, Moore CE, Montgomery BD. A defined, plant-based diet utilized in an outpatient cardiovascular clinic effectively treats hypercholesterolemia and hypertension and reduces medications. Clin Cardiol. 2018 Mar;41(3):307-313. doi: 10.1002/clc.22863. Epub 2018 Mar 25.
- Background: PubMed 28663251Heianza Y, Ma W, Manson JE, Rexrode KM, Qi L. Gut Microbiota Metabolites and Risk of Major Adverse Cardiovascular Disease Events and Death: A Systematic Review and Meta-Analysis of Prospective Studies. J Am Heart Assoc. 2017 Jun 29;6(7):e004947. doi: 10.1161/JAHA.116.004947.
- Background: PubMed 23614584Tang WH, Wang Z, Levison BS, Koeth RA, Britt EB, Fu X, Wu Y, Hazen SL. Intestinal microbial metabolism of phosphatidylcholine and cardiovascular risk. N Engl J Med. 2013 Apr 25;368(17):1575-84. doi: 10.1056/NEJMoa1109400.
- Background: PubMed 30535398Wang Z, Bergeron N, Levison BS, Li XS, Chiu S, Jia X, Koeth RA, Li L, Wu Y, Tang WHW, Krauss RM, Hazen SL. Impact of chronic dietary red meat, white meat, or non-meat protein on trimethylamine N-oxide metabolism and renal excretion in healthy men and women. Eur Heart J. 2019 Feb 14;40(7):583-594. doi: 10.1093/eurheartj/ehy799.
- Background: PubMed 32780794Crimarco 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.
- Background: PubMed 23563705Koeth RA, Wang Z, Levison BS, Buffa JA, Org E, Sheehy BT, Britt EB, Fu X, Wu Y, Li L, Smith JD, DiDonato JA, Chen J, Li H, Wu GD, Lewis JD, Warrier M, Brown JM, Krauss RM, Tang WH, Bushman FD, Lusis AJ, Hazen SL. Intestinal microbiota metabolism of L-carnitine, a nutrient in red meat, promotes atherosclerosis. Nat Med. 2013 May;19(5):576-85. doi: 10.1038/nm.3145. Epub 2013 Apr 7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Facilitated Vegan Diet and Omnivorous Diet in people with Cardiometabolic Risk Factors, run by David Grant U.S. Air Force Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change between intervention arms in baseline adjusted LDL-c at 4 weeks (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05071196, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2022.