Greenhouse Gas EmissionsNCT06733857
The Environmental Costs of Building Human Muscle
A study testing VEG2 and OMNI2 in people with Greenhouse Gas Emissions and Water Use, run by Game Changers Institute at 1 site in United States.
Trial summary
Among the general population, it has been established that plant-based diets confer significant environmental benefits (greenhouse gas emissions, land use, and water use) compared to omnivorous diets. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Greenhouse Gas Emissions, Water Use, Land Use
- What is being tested?
- VEG2 and OMNI2
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2018to 1 Mar 2020
- 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 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and females 18 - 40 years of age.
- Body mass index between 18 and 30.
- Recreationally active.
- Resistance training experienced (have previous performed resistance exercise, and are familiar with the basic movements).
Who cannot join
- Any diagnosed metabolic impairment (e.g. type 1 or 2 Diabetes) (as this may affect normal protein metabolism).
- Any diagnosed cardiovascular disease or hypertension (to avoid any complications associated with heavy exercise).
- Elevated blood pressure at the time of screening. (An average systolic blood pressure reading of ≥140mmHg over two or more measurements and an average diastolic blood pressure of ≥90mmHg over two or more measurements.)
- Chronic use of any prescribed or over the counter pharmaceuticals (that may modulate muscle protein metabolism).
- A personal or family history of epilepsy, seizures or schizophrenia.
- Allergic to mycoprotein / Quorn, penicillin, or milk.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Game Changers Institute
Laguna Niguel, California, 92677
About this study
Official title: The Environmental Costs of Building Human Muscle - A Comparison of Greenhouse Gas Emissions, Water Use and Land Use Between Plant-Based and Omnivorous Diets Following Sports Nutrition Protein Recommendations for Muscle Mass Accrual
Among the general population, it has been established that plant-based diets confer significant environmental benefits (greenhouse gas emissions, land use, and water use) compared to omnivorous diets.
However, sports nutrition recommendations for supporting resistance exercise-induced gains in muscle mass and strength differ substantially from population-level recommendations, especially for protein intake. Therefore the difference in environmental impact between omnivorous and plant-based diets for adults following such recommendations is as yet unknown.
Read more
A prior analysis found that a high-protein, non-animal-derived diet can support resistance training-induced gains in muscle mass and strength to the same extent as a protein-matched omnivorous diet. These findings align with previous research showing that, in the context of a high-protein diet, the source of protein - whether animal or plant-based - does not affect the rate of resistance exercise-induced gains in muscle mass and strength.
The present study therefore plans to retrospectively analyze the diet records from previously published research to determine the difference in environmental impact between the high protein animal-free and omnivorous diets.
The findings could highlight the unique difference in environmental impacts between those following high protein plant-based and omnivorous diets.
Read the detailed description
The development of skeletal muscle mass is associated with improved athletic performance and cardiometabolic health. Resistance exercise training (RET) and dietary protein ingestion are two key anabolic stimuli that, when repeated consistently over time, promote the accrual of skeletal muscle mass. High protein diets, considerably above the United States RDA of 0.8g·kg bm-1·d-1, are therefore often recommended to support RET adaptations, with meta-analyses highlighting protein intakes of ~1.6g·kg bm-1·d-1 for optimal stimulation of skeletal muscle hypertrophy and strength gains. The Academy of Nutrition and Dietetics suggest that intakes beyond this may be optimal under certain circumstances such as short periods of intensified training or when significantly reducing energy intake.
It has been demonstrated that, in the context of a high-protein diet as a whole, both animal and plant-based protein sources lead to similar RET-induced gains in muscle size and strength. However, the difference in environmental impacts of plant and animal-based protein sources has been shown to be substantial. Both the direct processes related to livestock management (for example, methane production by ruminants) and indirect processes through the inefficiency of using crops for animal feed rather than directly for human consumption contribute to substantially higher environmental impacts for animal-based foods relative to plant-based foods.
Such differences have been highlighted by modeling the environmental impact of replacing population-level food intake with plant-based diets. For instance, a systematic review of 34 studies using environmental life cycle assessments found that, compared to omnivorous diets that followed the same dietary guidelines and caloric content, plant-based diets achieved median reductions of 59% for land use, 45% for water use, and 50% for GHG emissions. Other research has found that high income countries shifting towards a plant-based diet would reduce their annual agricultural production emissions by 61%.
However, established sports nutrition recommendations for protein intake to support RET-induced muscular adaptations differ from general population-level intakes. Therefore the difference in environmental impact between omnivorous and plant-based diets for adults following such recommendations is as yet unknown.
The present study therefore aims to compare the environmental impacts of RET-induced gains in lean mass through consumption of a high protein omnivorous diet with a protein-matched plant-based diet. A previously published study assessed the effects of dietary protein source during a 10-week high volume resistance training program, and found a high protein (~2.0g·kg bm-1·d-1), exclusively plant-based diet and a protein-matched mixed diet led to similar increases in lean mass and strength accrual.
During this study, each participant was required to record dietary intake for a minimum of three days a week, allowing for detailed nutritional analyses. By utilizing environmental life cycle assessments and applying findings from previous meta-analyses, the investigators plan to compare the mean dietary intakes of the two groups, extrapolated across the intervention, to assess each diet's impact on greenhouse gas emissions, land use and water use through a comparative analysis.
- Conditions
- Greenhouse Gas Emissions, Water Use, Land Use
- Being tested
- VEG2, OMNI2
- Keywords
- Life cycle assessment, Environmental impact, Plant-based, Protein source, Hypertrophy, Sustainability
- Medical subject headings
- Hypertrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VEG2Behavioural
Participants were provided with a caloric target to place them in a ∼0 to 10% energy surplus, and a protein target of 2 g·kg bm-1·d-1. Participants were instructed to avoid animal products for ≥6 d per wk, focusing their intake on protein-rich non-animal-derived foods (for example, mycoprotein-containing products, pulses, soy). To facilitate reaching protein intake targets, the research team provided participants with mycoprotein-containing vegan products (∼1-2 products per day) to be used as the main protein source for some meals. This group also received 105-g mycoprotein (46-g protein, 10-g carbohydrate, 13-g fat, 348 kcal), 35-g post-training, and 70-g before bed.
OMNI2Behavioural
Participants were provided with a caloric target to place them in a ∼0 to 10% energy surplus, and a protein target of 2 g·kg bm-1·d-1. Participants in OMNI2 were instructed to consume an omnivorous diet, focusing their intake on high-quality animal-derived proteins (that is, meat, milk, yogurt, cheese). To facilitate reaching protein intake targets, the research team provided participants with a weekly supply (∼1-2 products per day) of chicken or beef to be used as the main protein source for some meals. This group also received 59-g supplemental milk protein daily (47-g protein, 2-g carbohydrate, <1-g fat, 198 kcal) 19.5-g to drink post-training and 39-g to drink before sleep.
| Study group | Role | What they receive |
|---|---|---|
| Plant-based | Experimental | Participants were to consume a high protein plant-based diet while completing a 10-week exercise program consisting of 5 exercise sessions per week. Receives: Behavioral: VEG2 |
| Omnivorous | Active comparator | Participants were to consume a high protein omnivorous diet while completing a 10-week exercise program consisting of 5 exercise sessions per week. Receives: Behavioral: OMNI2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diet-related greenhouse gas emissions - CO2 equivalents
Diet-related greenhouse gas emissions defined as CO2 equivalents resulting from food production, calculated by applying environmental life cycle assessments of individual foods and food categories to dietary records.
Measured: Applied to diet records for the duration of the 10-week intervention
Diet-related land use - hectares
Diet-related land use defined as agricultural land required for food production and measured in hectares, calculated by applying environmental life cycle assessments of individual foods and food categories to dietary records.
Measured: Applied to diet records for the duration of the 10-week intervention
Diet-related water use - cubic meters
Diet-related water use defined as freshwater required for food production and measured in cubic meters, calculated by applying environmental life cycle assessments of individual foods and food categories to dietary records.
Measured: Applied to diet records for the duration of the 10-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start1 May 2018
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Greenhouse Gas EmissionsStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Game Changers Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University of Exeter
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06733857
- Sponsor's protocol ID
- 41490987
- Status last verified
- Dec 2024
- First submitted
- 4 Dec 2024
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A spreadsheet with full food diary entries (redacted) which the environmental analyses will be based on.
Publications
Monteyne AJ, Coelho MOC, Murton AJ, Abdelrahman DR, Blackwell JR, Koscien CP, Knapp KM, Fulford J, Finnigan TJA, Dirks ML, Stephens FB, Wall BT. Vegan and Omnivorous High Protein Diets Support Comparable Daily Myofibrillar Protein Synthesis Rates and Skeletal Muscle Hypertrophy in Young Adults. J Nutr. 2023 Jun;153(6):1680-1695. doi: 10.1016/j.tjnut.2023.02.023. Epub 2023 Feb 22.
PubMed 36822394
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Environmental Costs of Building Human Muscle - A Comparison of Greenhouse Gas Emissions, Water Use and Land Use Between Plant-Based and Omnivorous Diets Following Sports Nutrition Protein Recommendations for Muscle Mass Accrual
- ClinicalTrials.gov ID
- NCT06733857
- Acronym / sponsor ID
- 41490987
- Conditions
- Greenhouse Gas Emissions, Water Use, Land Use
- Keywords
- Life cycle assessment, Environmental impact, Plant-based, Protein source, Hypertrophy, Sustainability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Game Changers InstituteUniversity, hospital or other
- Collaborators
- University of Exeter
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 13 Dec 2024 (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.
Among the general population, it has been established that plant-based diets confer significant environmental benefits (greenhouse gas emissions, land use, and water use) compared to omnivorous diets.
However, sports nutrition recommendations for supporting resistance exercise-induced gains in muscle mass and strength differ substantially from population-level recommendations, especially for protein intake. Therefore the difference in environmental impact between omnivorous and plant-based diets for adults following such recommendations is as yet unknown.
A prior analysis found that a high-protein, non-animal-derived diet can support resistance training-induced gains in muscle mass and strength to the same extent as a protein-matched omnivorous diet. These findings align with previous research showing that, in the context of a high-protein diet, the source of protein - whether animal or plant-based - does not affect the rate of resistance exercise-induced gains in muscle mass and strength.
The present study therefore plans to retrospectively analyze the diet records from previously published research to determine the difference in environmental impact between the high protein animal-free and omnivorous diets.
The findings could highlight the unique difference in environmental impacts between those following high protein plant-based and omnivorous diets.
Detailed description
The development of skeletal muscle mass is associated with improved athletic performance and cardiometabolic health. Resistance exercise training (RET) and dietary protein ingestion are two key anabolic stimuli that, when repeated consistently over time, promote the accrual of skeletal muscle mass. High protein diets, considerably above the United States RDA of 0.8g·kg bm-1·d-1, are therefore often recommended to support RET adaptations, with meta-analyses highlighting protein intakes of ~1.6g·kg bm-1·d-1 for optimal stimulation of skeletal muscle hypertrophy and strength gains. The Academy of Nutrition and Dietetics suggest that intakes beyond this may be optimal under certain circumstances such as short periods of intensified training or when significantly reducing energy intake.
It has been demonstrated that, in the context of a high-protein diet as a whole, both animal and plant-based protein sources lead to similar RET-induced gains in muscle size and strength. However, the difference in environmental impacts of plant and animal-based protein sources has been shown to be substantial. Both the direct processes related to livestock management (for example, methane production by ruminants) and indirect processes through the inefficiency of using crops for animal feed rather than directly for human consumption contribute to substantially higher environmental impacts for animal-based foods relative to plant-based foods.
Such differences have been highlighted by modeling the environmental impact of replacing population-level food intake with plant-based diets. For instance, a systematic review of 34 studies using environmental life cycle assessments found that, compared to omnivorous diets that followed the same dietary guidelines and caloric content, plant-based diets achieved median reductions of 59% for land use, 45% for water use, and 50% for GHG emissions. Other research has found that high income countries shifting towards a plant-based diet would reduce their annual agricultural production emissions by 61%.
However, established sports nutrition recommendations for protein intake to support RET-induced muscular adaptations differ from general population-level intakes. Therefore the difference in environmental impact between omnivorous and plant-based diets for adults following such recommendations is as yet unknown.
The present study therefore aims to compare the environmental impacts of RET-induced gains in lean mass through consumption of a high protein omnivorous diet with a protein-matched plant-based diet. A previously published study assessed the effects of dietary protein source during a 10-week high volume resistance training program, and found a high protein (~2.0g·kg bm-1·d-1), exclusively plant-based diet and a protein-matched mixed diet led to similar increases in lean mass and strength accrual.
During this study, each participant was required to record dietary intake for a minimum of three days a week, allowing for detailed nutritional analyses. By utilizing environmental life cycle assessments and applying findings from previous meta-analyses, the investigators plan to compare the mean dietary intakes of the two groups, extrapolated across the intervention, to assess each diet's impact on greenhouse gas emissions, land use and water use through a comparative analysis.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plant-based | Experimental | Behavioral: VEG2Participants were to consume a high protein plant-based diet while completing a 10-week exercise program consisting of 5 exercise sessions per week. |
| Omnivorous | Active comparator | Behavioral: OMNI2Participants were to consume a high protein omnivorous diet while completing a 10-week exercise program consisting of 5 exercise sessions per week. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Males and females 18 - 40 years of age.
- Body mass index between 18 and 30.
- Recreationally active.
- Resistance training experienced (have previous performed resistance exercise, and are familiar with the basic movements).
Key exclusion criteria (7 listed)
- Any diagnosed metabolic impairment (e.g. type 1 or 2 Diabetes) (as this may affect normal protein metabolism).
- Any diagnosed cardiovascular disease or hypertension (to avoid any complications associated with heavy exercise).
- Elevated blood pressure at the time of screening. (An average systolic blood pressure reading of ≥140mmHg over two or more measurements and an average diastolic blood pressure of ≥90mmHg over two or more measurements.)
- Chronic use of any prescribed or over the counter pharmaceuticals (that may modulate muscle protein metabolism).
- A personal or family history of epilepsy, seizures or schizophrenia.
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 |
|---|---|---|
| VEG2Participants were provided with a caloric target to place them in a ∼0 to 10% energy surplus, and a protein target of 2 g·kg bm-1·d-1. Participants were instructed to avoid animal products for ≥6 d per wk, focusing their intake on protein-rich non-animal-derived foods (for example, mycoprotein-containing products, pulses, soy). To facilitate reaching protein intake targets, the research team provided participants with mycoprotein-containing vegan products (∼1-2 products per day) to be used as the main protein source for some meals. This group also received 105-g mycoprotein (46-g protein, 10-g carbohydrate, 13-g fat, 348 kcal), 35-g post-training, and 70-g before bed. | Behavioural | Plant-based |
| OMNI2Participants were provided with a caloric target to place them in a ∼0 to 10% energy surplus, and a protein target of 2 g·kg bm-1·d-1. Participants in OMNI2 were instructed to consume an omnivorous diet, focusing their intake on high-quality animal-derived proteins (that is, meat, milk, yogurt, cheese). To facilitate reaching protein intake targets, the research team provided participants with a weekly supply (∼1-2 products per day) of chicken or beef to be used as the main protein source for some meals. This group also received 59-g supplemental milk protein daily (47-g protein, 2-g carbohydrate, <1-g fat, 198 kcal) 19.5-g to drink post-training and 39-g to drink before sleep. | Behavioural | Omnivorous |
Primary outcome
Diet-related greenhouse gas emissions - CO2 equivalents
Time frame: Applied to diet records for the duration of the 10-week intervention
Diet-related greenhouse gas emissions defined as CO2 equivalents resulting from food production, calculated by applying environmental life cycle assessments of individual foods and food categories to dietary records.
Diet-related land use - hectares
Time frame: Applied to diet records for the duration of the 10-week intervention
Diet-related land use defined as agricultural land required for food production and measured in hectares, calculated by applying environmental life cycle assessments of individual foods and food categories to dietary records.
Diet-related water use - cubic meters
Time frame: Applied to diet records for the duration of the 10-week intervention
Diet-related water use defined as freshwater required for food production and measured in cubic meters, calculated by applying environmental life cycle assessments of individual foods and food categories to dietary records.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
- Results publication: PubMed 36822394Monteyne AJ, Coelho MOC, Murton AJ, Abdelrahman DR, Blackwell JR, Koscien CP, Knapp KM, Fulford J, Finnigan TJA, Dirks ML, Stephens FB, Wall BT. Vegan and Omnivorous High Protein Diets Support Comparable Daily Myofibrillar Protein Synthesis Rates and Skeletal Muscle Hypertrophy in Young Adults. J Nutr. 2023 Jun;153(6):1680-1695. doi: 10.1016/j.tjnut.2023.02.023. Epub 2023 Feb 22.
- Individual participant dataSharing planned: Yes. A spreadsheet with full food diary entries (redacted) which the environmental analyses will be based on.
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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 VEG2 and OMNI2 in people with Greenhouse Gas Emissions and Water Use, run by Game Changers Institute 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 4 inclusion and 7 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: finished, as of the sponsor's last update on 13 Dec 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Diet-related greenhouse gas emissions - CO2 equivalents (time frame: Applied to diet records for the duration of the 10-week intervention). The study lists 3 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 NCT06733857, which also lists 1 linked publication.
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 13 Dec 2024.