Well-beingNCT04869163
Sustained Meat and Alternative Intake (PRotEin DIet SatisfacTION Trial 4) (PREDITION)
A study testing Non-red meat in people with Well-being, run by University of Auckland, New Zealand at 1 site in New Zealand.
Trial summary
Introduction The trend of flexitarian eating patterns is on the rise, with young adults amongst the biggest adopters claiming health and environmental reasons to reduce red meat intake. Read more about this study
- Who is it for?
- Ages 20 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Well-being
- What is being tested?
- Non-red meat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteNew Zealand
- Study dates
- 17 May 2021to 30 Sep 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 20 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- All participants are required to be omnivores who in the last 2 months consumed at least 2-3 meals per week containing meat of any description (red or white fleshed meat, including fish).
- All participants must be willing to consume both red meat and meat-analogues for the purposes of the trial.
Who cannot join
- Obesity (BMI ≥ 30 kg/m2),
- Hyperlipidaemia
- Anosmia and ageusia (issues with smell and taste),
- Use of medications (except for occasional NSAIDs and antihistamines) or recreational drugs, or who smoke tobacco
- Disordered eating
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sustained Wellbeing Benefits of Red Meat Consumption in a Modern Flexitarian Diet: A Study Protocol for a 10 Week Randomised Clinical Trial
Introduction The trend of flexitarian eating patterns is on the rise, with young adults amongst the biggest adopters claiming health and environmental reasons to reduce red meat intake. Nutrient dense meat and animal products are often the lynchpin of these diets, even when consumed only occasionally and in moderate amounts. Red meat provides forms and concentrations of essential proteins, lipids, and micronutrients that are scarce in exclusively vegetarian regimens. The aim of this investigation is to consider the effects of moderate consumption of lean red meat as part of an otherwise vegetarian balanced diet and its impact on biomarkers of sustained health and wellbeing.
Methods and analyses A cohort of healthy, young (20-34 years) male and female participants will take part in two-arm parallel, randomised-controlled trial for a duration of 12 weeks, with a 3-month post follow-up. The trial will commence with a two-week assessment period followed by allocation to the intervention arms. The intervention will include the consumption of red meat or meat-alternatives three times per week for 10 weeks. Blood samples of the participants will be measured for changes in erythrocyte fatty acid distribution, circulating amino acids, neurotransmitters, markers of mineral status and inflammatory markers. Questionnaires to assess wellbeing and mental health will be undertaken every two weeks. Body composition, physical function test, blood measurements will be assessed at allocation (t0), week five into the intervention (t5) and post intervention (t10).
Read more
Discussion To our knowledge this is the first randomised controlled trial (RCT) investigating the overarching health consequences of consuming NZ pasture fed red meat or no meat, as part of a healthy diet.
Ethics and dissemination The trial was approved by the New Zealand Ministry of Health's Health and Disability Ethics Committees (20/STH/157).
Read the detailed description
Study Design and Setting The study is a parallel RCT comprising a 2-week pre-intervention assessment, a 10-week intervention period and a 22-week post follow up. Participants will all eat a balanced plant-based basal diet and be randomised to also consume either red meat ('Flexitarian' arm) or a meat substitute ('Vegetarian' arm). The meat will be pasture-raised beef and lamb butchered and packaged to our specifications in New Zealand, while the meat substitute will be commercially available plant-based products.
Recognising that there are many interpretations of the terms vegetarian and flexitarian, in this study we define vegetarian as ovo-lacto vegetarian and flexitarian as 'a vegetarian diet with moderate amounts of red meat'. Both arms can consume eggs and dairy products, but no chicken, pork or fish, and no red meat other than that supplied by the researchers.
The study is designed around pairs of young adult consumers who share meals and are therefore likely to engage over the values and challenges of developing a healthy lifestyle. Each couple/household unit (see Recruitment) will receive a weekly delivery of a vegetarian meal kit containing complete ingredients for cooking 3-4 evening meals. Depending on their allocation, the couple will also receive an allotment of frozen red meat or meat-analogue to use for preparing 3 additional evening meals. To facilitate cooking and keep the behaviours of the arms aligned, we will provide recipe cards, shopping guidance and video instructions. All other meals during the week are self-catered and must adhere to study guidelines.
The quantity of meat will be sufficient to provide 350-500 g cooked weight per person per week. This conforms to the latest international recommendations for maximum intake 7 and the reported typical frequencies of red meat consumption. The meat alternative will be similar in quantity, form and function. It is vegetarian-friendly and serves to balance the total protein and fat intake of the arms.
Changes in objective and self-assessed subjective health variables over time and between arms will be investigated. These include physical function, body composition, metabolic health biomarkers and psychological wellbeing.
- Conditions
- Well-being
- Being tested
- Non-red meat
- Keywords
- nutrition, meat, mental health
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-red meatOther
Red meat analogues and alternatives
| Study group | Role | What they receive |
|---|---|---|
| red meat consumers | Active comparator | Consumes red meat 3 times a week Receives: Other: Non-red meat |
| non-red meat consumers | Experimental | Consumes a non-red meat comparison product 3 times a week Receives: Other: Non-red meat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Polyunsaturated fatty acids
Concentrations of polyunsaturated fatty acids (18:2 n-6, 18:3 n-3, 20:4 n-6, 20:5 n-3, 22:5 n-3, 22:6 n-3) in erythrocyte membranes
Measured: Baseline to 10 week comparison
Secondary outcomes (4)
Psychological and mental wellbeing
Multidimensional Fatigue Symptom Inventory Short Form (MSFI-SF). The Total MFSI-SF score ranges from -24 to 96, with higher values indicating greater fatigue.
The five subscales of the MFSI each ranges from 0 to 24:
- General subscale = ranges from 0 to 24, with higher values indicating greater fatigue (worse outcomes)
- Physical subscale = ranges from 0 to 24, with higher values indicating greater fatigue (worse outcomes)
- Emotional subscale = ranges from 0 to 24, with higher values indicating greater fatigue (worse outcomes)
- Mental subscale = ranges from 0 to 24, with higher values indicating greater fatigue (worse outcomes)
- Vigor subscale = ranges from 0 to 24, with higher values indicating greater vigor (better outcomes) Total MFSI-SF score = (General + Physical + Emotional + Mental) - Vigor = Total Score ranges from -24 to 96 with higher values indicating greater fatigue (worse outcomes).
Measured: Change from baseline to 10 week comparison
Psychological and mental wellbeing
Depression Anxiety Stress Scales-Short form (DASS-21) Depression score ranges from 0 to 42 (raw scores 0 to 21, which are then multiplied by 2 to be equivalent to the DASS-42), with higher numbers indicating greater depression (worse outcome).
Anxiety score ranges from 0 to 42 (raw scores 0 to 21, which are then multiplied by 2 to be equivalent to the DASS-42), with higher numbers indicating greater anxiety (worse outcome).
Stress score ranges from 0 to 42 (raw scores 0 to 21, which are then multiplied by 2 to be equivalent to the DASS-42), with higher numbers indicating greater stress (worse outcome).
Measured: Change from baseline to 10 week comparison
Psychological and mental wellbeing
WHO-Five Well-Being Index (WHO 5). The raw score ranges from 0 to 25, with 0 representing the worst and 100 representing the best possible quality of life The percentage score ranges from 0 to 100, with 0 representing the worst and 100 representing the best possible quality of life
Measured: Change from baseline to 10 week comparison
Psychological and mental wellbeing
Positive Eating Scale (PES) Total Positive Eating score (PES-Tot) = ranges from 1 to 4, with higher values indicating better experiences with eating Satisfaction with Eating subscale (PES-Sat) = ranges from 1 to 4, with higher values indicating more satisfaction with eating Pleasure when Eating subscale (PES-Pl) = ranges from 1 to 4, with higher values indicating more pleasure when eating
Measured: Change from baseline to 10 week comparison
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start17 May 2021
- Primary completion22 Dec 2021
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Well-beingStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Auckland, New Zealand
- Sponsor type
- University, hospital or other
- Collaborators
- AgResearch, University of Otago
- Responsible party
- Principal investigator, Dr Andrea Braakhuis, University of Auckland, New Zealand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04869163
- Sponsor's protocol ID
- 5000927-4
- Status last verified
- Nov 2023
- First submitted
- 18 Apr 2021
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Access to data will be granted to appropriate members of the research team and to authorised representatives from the host institution to monitor or audit the study and ensure compliance with regulations. Data will be made available to external academics on reasonable request.
Publications
Morton L, Cameron-Smith D, Gillies N, Fraser K, Braakhuis A. Pasture-Raised Red Meat Compared with Plant-Based Meat Alternatives Within Healthy Dietary Patterns: Effects on Polyunsaturated Fatty Acid Status and Cardiometabolic Health in a Randomized Dietary Intervention. Am J Clin Nutr. 2026 Oct 1:101564. doi: 10.1016/j.ajcnut.2026.101564. Online ahead of print.
PubMed 42822834Worthington A, Gillies N, Hannaford R, Roy R, Braakhuis A. Implementing multicomponent, eHealth-based behaviour change support within a dietary intervention trial improves adherence to study-related behaviours in healthy young adults. BMC Nutr. 2023 Nov 21;9(1):134. doi: 10.1186/s40795-023-00798-7.
PubMed 37990250Gillies NA, Worthington A, Li L, Conner TS, Bermingham EN, Knowles SO, Cameron-Smith D, Hannaford R, Braakhuis A. Adherence and eating experiences differ between participants following a flexitarian diet including red meat or a vegetarian diet including plant-based meat alternatives: findings from a 10-week randomised dietary intervention trial. Front Nutr. 2023 Jun 14;10:1174726. doi: 10.3389/fnut.2023.1174726. eCollection 2023.
PubMed 37388633Braakhuis A, Gillies N, Worthington A, Knowles S, Conner T, Roy R, Pham T, Bermingham E, Cameron-Smith D. A Modern Flexitarian Dietary Intervention Incorporating Web-Based Nutrition Education in Healthy Young Adults: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2021 Dec 21;10(12):e30909. doi: 10.2196/30909.
PubMed 34931994
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sustained Wellbeing Benefits of Red Meat Consumption in a Modern Flexitarian Diet: A Study Protocol for a 10 Week Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT04869163
- Acronym / sponsor ID
- 5000927-4
- Conditions
- Well-being
- Keywords
- nutrition, meat, mental health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of Auckland, New ZealandUniversity, hospital or other
- Collaborators
- AgResearch, University of Otago
- Study start
- 17 May 2021 (actual)
- Primary completion
- 22 Dec 2021 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 3 May 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.
Introduction The trend of flexitarian eating patterns is on the rise, with young adults amongst the biggest adopters claiming health and environmental reasons to reduce red meat intake. Nutrient dense meat and animal products are often the lynchpin of these diets, even when consumed only occasionally and in moderate amounts. Red meat provides forms and concentrations of essential proteins, lipids, and micronutrients that are scarce in exclusively vegetarian regimens. The aim of this investigation is to consider the effects of moderate consumption of lean red meat as part of an otherwise vegetarian balanced diet and its impact on biomarkers of sustained health and wellbeing.
Methods and analyses A cohort of healthy, young (20-34 years) male and female participants will take part in two-arm parallel, randomised-controlled trial for a duration of 12 weeks, with a 3-month post follow-up. The trial will commence with a two-week assessment period followed by allocation to the intervention arms. The intervention will include the consumption of red meat or meat-alternatives three times per week for 10 weeks. Blood samples of the participants will be measured for changes in erythrocyte fatty acid distribution, circulating amino acids, neurotransmitters, markers of mineral status and inflammatory markers. Questionnaires to assess wellbeing and mental health will be undertaken every two weeks. Body composition, physical function test, blood measurements will be assessed at allocation (t0), week five into the intervention (t5) and post intervention (t10).
Discussion To our knowledge this is the first randomised controlled trial (RCT) investigating the overarching health consequences of consuming NZ pasture fed red meat or no meat, as part of a healthy diet.
Ethics and dissemination The trial was approved by the New Zealand Ministry of Health's Health and Disability Ethics Committees (20/STH/157).
Detailed description
Study Design and Setting The study is a parallel RCT comprising a 2-week pre-intervention assessment, a 10-week intervention period and a 22-week post follow up. Participants will all eat a balanced plant-based basal diet and be randomised to also consume either red meat ('Flexitarian' arm) or a meat substitute ('Vegetarian' arm). The meat will be pasture-raised beef and lamb butchered and packaged to our specifications in New Zealand, while the meat substitute will be commercially available plant-based products.
Recognising that there are many interpretations of the terms vegetarian and flexitarian, in this study we define vegetarian as ovo-lacto vegetarian and flexitarian as 'a vegetarian diet with moderate amounts of red meat'. Both arms can consume eggs and dairy products, but no chicken, pork or fish, and no red meat other than that supplied by the researchers.
The study is designed around pairs of young adult consumers who share meals and are therefore likely to engage over the values and challenges of developing a healthy lifestyle. Each couple/household unit (see Recruitment) will receive a weekly delivery of a vegetarian meal kit containing complete ingredients for cooking 3-4 evening meals. Depending on their allocation, the couple will also receive an allotment of frozen red meat or meat-analogue to use for preparing 3 additional evening meals. To facilitate cooking and keep the behaviours of the arms aligned, we will provide recipe cards, shopping guidance and video instructions. All other meals during the week are self-catered and must adhere to study guidelines.
The quantity of meat will be sufficient to provide 350-500 g cooked weight per person per week. This conforms to the latest international recommendations for maximum intake 7 and the reported typical frequencies of red meat consumption. The meat alternative will be similar in quantity, form and function. It is vegetarian-friendly and serves to balance the total protein and fat intake of the arms.
Changes in objective and self-assessed subjective health variables over time and between arms will be investigated. These include physical function, body composition, metabolic health biomarkers and psychological wellbeing.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| red meat consumers | Active comparator | Other: Non-red meatConsumes red meat 3 times a week |
| non-red meat consumers | Experimental | Other: Non-red meatConsumes a non-red meat comparison product 3 times a week |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- All participants are required to be omnivores who in the last 2 months consumed at least 2-3 meals per week containing meat of any description (red or white fleshed meat, including fish).
- All participants must be willing to consume both red meat and meat-analogues for the purposes of the trial.
Key exclusion criteria (5 listed)
- Obesity (BMI ≥ 30 kg/m2),
- Hyperlipidaemia
- Anosmia and ageusia (issues with smell and taste),
- Use of medications (except for occasional NSAIDs and antihistamines) or recreational drugs, or who smoke tobacco
- Disordered eating
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 |
|---|---|---|
| Non-red meatRed meat analogues and alternatives | Other | non-red meat consumers, red meat consumers |
Primary outcome
Polyunsaturated fatty acids
Time frame: Baseline to 10 week comparison
Concentrations of polyunsaturated fatty acids (18:2 n-6, 18:3 n-3, 20:4 n-6, 20:5 n-3, 22:5 n-3, 22:6 n-3) in erythrocyte membranes
4 secondary outcomes
Psychological and mental wellbeing
Time frame: Change from baseline to 10 week comparison
Psychological and mental wellbeing
Time frame: Change from baseline to 10 week comparison
Psychological and mental wellbeing
Time frame: Change from baseline to 10 week comparison
Psychological and mental wellbeing
Time frame: Change from baseline to 10 week comparison
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 28 Nov 2023.
- Derived from this study: PubMed 42822834Morton L, Cameron-Smith D, Gillies N, Fraser K, Braakhuis A. Pasture-Raised Red Meat Compared with Plant-Based Meat Alternatives Within Healthy Dietary Patterns: Effects on Polyunsaturated Fatty Acid Status and Cardiometabolic Health in a Randomized Dietary Intervention. Am J Clin Nutr. 2026 Oct 1:101564. doi: 10.1016/j.ajcnut.2026.101564. Online ahead of print.
- Derived from this study: PubMed 37990250Worthington A, Gillies N, Hannaford R, Roy R, Braakhuis A. Implementing multicomponent, eHealth-based behaviour change support within a dietary intervention trial improves adherence to study-related behaviours in healthy young adults. BMC Nutr. 2023 Nov 21;9(1):134. doi: 10.1186/s40795-023-00798-7.
- Derived from this study: PubMed 37388633Gillies NA, Worthington A, Li L, Conner TS, Bermingham EN, Knowles SO, Cameron-Smith D, Hannaford R, Braakhuis A. Adherence and eating experiences differ between participants following a flexitarian diet including red meat or a vegetarian diet including plant-based meat alternatives: findings from a 10-week randomised dietary intervention trial. Front Nutr. 2023 Jun 14;10:1174726. doi: 10.3389/fnut.2023.1174726. eCollection 2023.
- Derived from this study: PubMed 34931994Braakhuis A, Gillies N, Worthington A, Knowles S, Conner T, Roy R, Pham T, Bermingham E, Cameron-Smith D. A Modern Flexitarian Dietary Intervention Incorporating Web-Based Nutrition Education in Healthy Young Adults: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2021 Dec 21;10(12):e30909. doi: 10.2196/30909.
- Individual participant dataSharing planned: Yes. Access to data will be granted to appropriate members of the research team and to authorised representatives from the host institution to monitor or audit the study and ensure compliance with regulations. Data will be made available to external academics on reasonable request.
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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 Non-red meat in people with Well-being, run by University of Auckland, New Zealand at 1 site in New Zealand.
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 2 inclusion and 5 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 28 Nov 2023. 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 New Zealand. 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?
Polyunsaturated fatty acids (time frame: Baseline to 10 week comparison). 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 NCT04869163, which also lists 4 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 28 Nov 2023.