Healthy ParticipantsPhase 2NCT04950595
Plant-based Mince vs Beef Mince: Does One Make You Feel Fuller for Longer?
A Phase 2 study testing Plant-based mince and Beef mince in people with Healthy Participants, run by Commonwealth Scientific and Industrial Research Organisation, Australia.
Trial summary
This project will provide preliminary evidence to support whether V2 plant-based mince could contribute to increased satiety following a meal, which may assist in a weight reduction dietary regime when substituted for standard beef mince. Read more about this study
- Who is it for?
- Ages 18 to 56 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Plant-based mince and Beef mince
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- Aug 2021to Oct 2021
- Phase
- Phase 2
- 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 56 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male individuals
- Aged between ≥18 \& ≤56 years at informed consent
- Body mass index (BMI) ≥18.5 kg/m² and ≤27.5 kg/m² (confirmed during screening appointment)
- Weight stable for last 6 months (< +/- 5kg change)*
- Consume red meat regularly (at least 1 x week)
- Willing to provide written Informed Consent
- Be able to attend the CSIRO nutrition clinic for around 7 hours on two occasions across a two week period.
- Self-reported
Who cannot join
- Health conditions* that could affect appetite/food intake or require a prescribed diet such as gastrointestinal diseases [including, but not limited to diverticulitis, ulcerative colitis, Crohn's disease, or coeliac disease], type 1 or type 2 diabetes, cancer, renal or liver diseases
- Gastrointestinal symptoms* (i.e. pain, reflux, diarrhea, or constipation), surgeries* (i.e. bariatric surgery such as gastric banding) or use of medications* (i.e. appetite suppressants, steroids) known to potentially affect energy intake, appetite, or gastrointestinal motor function
- Known food allergies or intolerances to the study intervention products^
- History of eating disorders*
- Unable or unwilling to consume red meat
- Current smoker (or history of smoking within the last six months)
- History of or known presence of alcohol abuse or illicit drug use*
- Received an investigational drug within 28 days prior to Visit 1 that in the opinion of the investigator may affect the applicant's ability to participate in the study or the study results *Self-reported, no clinical testing will be performed
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Defining the Satiety Characteristics of Plant-based Mince in Comparison to Standard Beef Mince: Does Plant-based Mince Make You Feel Fuller for Longer?
This project will provide preliminary evidence to support whether V2 plant-based mince could contribute to increased satiety following a meal, which may assist in a weight reduction dietary regime when substituted for standard beef mince.
Read the detailed description
Growing concerns about the sustainability and environmental impacts of red meat consumption have resulted in the increased uptake of plant-based red meat substitutes by consumers worldwide. In addition to the environmental benefits of these products, it has also been argued that they have the potential to offer additional health benefits. One such health benefit, and the focus of this study, is the potential for plant-based meats to produce a greater satiating effect in comparison to traditional meat products, and therefore potentially assist in supporting weight loss or weight maintenance in the longer term.
To address this question, the investigators will assess the effect of substituting V2 mince for beef mince in a standard pasta meal on both the amount of the meal consumed and on feelings of fullness in the period after eating, as assessed by both subjective reporting, objective (biochemical) measures and the amount consumed at a subsequent meal occasion. The results of this study will provide proof-of-concept evidence of the potential enhanced satiating effects of V2 mince, and therefore whether it could potentially assist in a weight reduction dietary regime when substituted for standard beef mince.
This project will provide preliminary evidence to support whether V2 plant-based mince could contribute to increased satiety following a meal, which may assist in a weight reduction dietary regime when substituted for standard beef mince.
The investigators specific hypotheses are:
H1: That participants will consume less KJ when consuming the V2 plant-based meal in comparison to the equivalent meal prepared with beef mince.
H2: That fullness will be maintained to the same extent following consumption of the V2 and meat-based meals, such that participants will not increase their consumption at the subsequent meal period to compensate for this energy deficit.
The null hypothesis is that a meal containing V2 plant-based meat is no more satiating than an equivalent meal containing beef mince.
This study is a single-blinded, randomised cross-over trial, designed to compare the effect of a meal prepared using V2 plant-based meat to an equivalent meal prepared with beef mince on the amount consumed in the current meal and objective and subjective measures of post-prandial satiety. The test meals will be formulated so that the meal will contain 45% of V2 plant-based meat or beef mince prior to the meal being cooked. Participants will be provided with a serving that is expected to be in excess of what they would be able to comfortably eat, and instructed to eat until comfortably full. The amount of the leftovers will be carefully weighed and used to calculate the volume, energy and macronutrient intake consumed.
180 mins after lunch (~3 pm), subjects will be presented with a standard cold buffet meal (including sliced bread, chicken, ham, cheese, mayonnaise, custard, yogurt, fruit salad and water) in excess of what they are expected to consume and allowed to eat ad libitum for up to 30 minutes. Participants will be asked to eat until they are comfortably full. The amount of each item consumed will be weighed and used to calculate total volume, energy and macronutrient intake.
- Conditions
- Healthy Participants
- Being tested
- Plant-based mince, Beef mince
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plant-based minceOther
Spaghetti bolognaise meal made with plant-based mince
Beef minceOther
Spaghetti bolognaise meal made with beef mince
| Study group | Role | What they receive |
|---|---|---|
| Beef mince group | Experimental | The test meal provided at lunch will be made up of 45% beef mince, with all remaining ingredients the same as the other arm. Receives: Other: Beef mince |
| Plant-based mince group | Experimental | The test meal provided at lunch will be made up of 45% plant-based mince, with all remaining ingredients the same as the other arm. Receives: Other: Plant-based mince |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy (kJ) consumed in test meals
To determine whether a meal containing V2 plant-based meat is more satiating than an equivalent meal containing beef mince, as assessed by the energy (kJ) of the respective meals consumed to achieve fullness.
Measured: 3 hours
Visual Analogue Scale (VAS)
Maintenance of satiety in the post-prandial period as measured by the VAS. Participants will indicate their perceived feelings of hunger, satiety, fullness and prospective food consumption at each time point on the VAS by moving the slider bar along a 10 mm line displayed on an iPad Question 1: How hungry do you feel? Answers to question 1: Please indicate how you are feeling at this moment by moving the slider bar to the appropriate point on each scale below (I am not hungry at all________________I have never been more hungry) Question 2: How satisfied do you feel? Answer to Q 2: I am completely empty_______________________________I cannot eat another bite.
Question 3: How full do you feel? Anwer to Q3: Not at all full______________________Totally full Question 4: How much do you think you can eat? Answer to Q4: Nothing at all_________________________A lot.
Measured: 4 hours
Secondary outcomes (6)
Energy consumed at subsequent buffet meal (kJ)
measuring post-prandial satiety
Measured: 4 hours
Glucose (mmol/L) (plasma biomarker)
measuring post-prandial satiety
Measured: 4 hours
insulin (pmol) (plasma biomarker)
measuring post-prandial satiety
Measured: 4 hours
ghrelin (mcg) (plasma biomarker)
measuring post-prandial satiety
Measured: 4 hours
cholecystokinin (CCK) (plasma biomarker)
measuring post-prandial satiety
Measured: 4 hours
glucagon-like peptide-1 (GLP-1) (plasma biomarker)
measuring post-prandial satiety
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2021
- Study startAug 2021 (estimated)
- Primary completionOct 2021 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Single-centre, single-blinded, randomised, cross-over trial.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Commonwealth Scientific and Industrial Research Organisation, Australia
- Sponsor type
- Other government
- Collaborators
- v2food (https://www.v2food.com/)
- Responsible party
- Principal investigator, Bradley Klingner, Commonwealth Scientific and Industrial Research Organisation, Australia
- Investigators
- Bev Muhlhausler, BSc(Hons) PhD, Principal investigator, Commonwealth Scientific and Industrial Research Organisation, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04950595
- Sponsor's protocol ID
- VTF001
- Status last verified
- Jun 2021
- First submitted
- 10 Jun 2021
- Last updated
- 6 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining the Satiety Characteristics of Plant-based Mince in Comparison to Standard Beef Mince: Does Plant-based Mince Make You Feel Fuller for Longer?
- ClinicalTrials.gov ID
- NCT04950595
- Acronym / sponsor ID
- VTF001
- Conditions
- Healthy Participants
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Commonwealth Scientific and Industrial Research Organisation, AustraliaOther government
- Collaborators
- v2food (https://www.v2food.com/)
- Study start
- Aug 2021 (estimated)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 6 Jul 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.
This project will provide preliminary evidence to support whether V2 plant-based mince could contribute to increased satiety following a meal, which may assist in a weight reduction dietary regime when substituted for standard beef mince.
Detailed description
Growing concerns about the sustainability and environmental impacts of red meat consumption have resulted in the increased uptake of plant-based red meat substitutes by consumers worldwide. In addition to the environmental benefits of these products, it has also been argued that they have the potential to offer additional health benefits. One such health benefit, and the focus of this study, is the potential for plant-based meats to produce a greater satiating effect in comparison to traditional meat products, and therefore potentially assist in supporting weight loss or weight maintenance in the longer term.
To address this question, the investigators will assess the effect of substituting V2 mince for beef mince in a standard pasta meal on both the amount of the meal consumed and on feelings of fullness in the period after eating, as assessed by both subjective reporting, objective (biochemical) measures and the amount consumed at a subsequent meal occasion. The results of this study will provide proof-of-concept evidence of the potential enhanced satiating effects of V2 mince, and therefore whether it could potentially assist in a weight reduction dietary regime when substituted for standard beef mince.
This project will provide preliminary evidence to support whether V2 plant-based mince could contribute to increased satiety following a meal, which may assist in a weight reduction dietary regime when substituted for standard beef mince.
The investigators specific hypotheses are:
H1: That participants will consume less KJ when consuming the V2 plant-based meal in comparison to the equivalent meal prepared with beef mince.
H2: That fullness will be maintained to the same extent following consumption of the V2 and meat-based meals, such that participants will not increase their consumption at the subsequent meal period to compensate for this energy deficit.
The null hypothesis is that a meal containing V2 plant-based meat is no more satiating than an equivalent meal containing beef mince.
This study is a single-blinded, randomised cross-over trial, designed to compare the effect of a meal prepared using V2 plant-based meat to an equivalent meal prepared with beef mince on the amount consumed in the current meal and objective and subjective measures of post-prandial satiety. The test meals will be formulated so that the meal will contain 45% of V2 plant-based meat or beef mince prior to the meal being cooked. Participants will be provided with a serving that is expected to be in excess of what they would be able to comfortably eat, and instructed to eat until comfortably full. The amount of the leftovers will be carefully weighed and used to calculate the volume, energy and macronutrient intake consumed.
180 mins after lunch (~3 pm), subjects will be presented with a standard cold buffet meal (including sliced bread, chicken, ham, cheese, mayonnaise, custard, yogurt, fruit salad and water) in excess of what they are expected to consume and allowed to eat ad libitum for up to 30 minutes. Participants will be asked to eat until they are comfortably full. The amount of each item consumed will be weighed and used to calculate total volume, energy and macronutrient intake.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Single-centre, single-blinded, randomised, cross-over trial.
| Arm | Type | Receives |
|---|---|---|
| Beef mince group | Experimental | Other: Beef minceThe test meal provided at lunch will be made up of 45% beef mince, with all remaining ingredients the same as the other arm. |
| Plant-based mince group | Experimental | Other: Plant-based minceThe test meal provided at lunch will be made up of 45% plant-based mince, with all remaining ingredients the same as the other arm. |
Who may qualify
- Ages
- 18 to 56 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Male individuals
- Aged between ≥18 \& ≤56 years at informed consent
- Body mass index (BMI) ≥18.5 kg/m² and ≤27.5 kg/m² (confirmed during screening appointment)
- Weight stable for last 6 months (< +/- 5kg change)*
- Consume red meat regularly (at least 1 x week)
Key exclusion criteria (8 listed)
- Health conditions* that could affect appetite/food intake or require a prescribed diet such as gastrointestinal diseases [including, but not limited to diverticulitis, ulcerative colitis, Crohn's disease, or coeliac disease], type 1 or type 2 diabetes, cancer, renal or liver diseases
- Gastrointestinal symptoms* (i.e. pain, reflux, diarrhea, or constipation), surgeries* (i.e. bariatric surgery such as gastric banding) or use of medications* (i.e. appetite suppressants, steroids) known to potentially affect energy intake, appetite, or gastrointestinal motor function
- Known food allergies or intolerances to the study intervention products^
- History of eating disorders*
- Unable or unwilling to consume red meat
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 |
|---|---|---|
| Plant-based minceSpaghetti bolognaise meal made with plant-based mince | Other | Plant-based mince group |
| Beef minceSpaghetti bolognaise meal made with beef mince | Other | Beef mince group |
Primary outcome
Energy (kJ) consumed in test meals
Time frame: 3 hours
To determine whether a meal containing V2 plant-based meat is more satiating than an equivalent meal containing beef mince, as assessed by the energy (kJ) of the respective meals consumed to achieve fullness.
Visual Analogue Scale (VAS)
Time frame: 4 hours
Maintenance of satiety in the post-prandial period as measured by the VAS. Participants will indicate their perceived feelings of hunger, satiety, fullness and prospective food consumption at each time point on the VAS by moving the slider bar along a 10 mm line displayed on an iPad Question 1: How hungry do you feel? Answers to question 1: Please indicate how you are feeling at this moment by moving the slider bar to the appropriate point on each scale below (I am not hungry at all________________I have never been more hungry) Question 2: How satisfied do you feel? Answer to Q 2: I am completely empty_______________________________I cannot eat another bite. Question 3: How full do you feel? Anwer to Q3: Not at all full______________________Totally full Question 4: How much do you think you can eat? Answer to Q4: Nothing at all_________________________A lot.
6 secondary outcomes
Energy consumed at subsequent buffet meal (kJ)
Time frame: 4 hours
Glucose (mmol/L) (plasma biomarker)
Time frame: 4 hours
insulin (pmol) (plasma biomarker)
Time frame: 4 hours
ghrelin (mcg) (plasma biomarker)
Time frame: 4 hours
cholecystokinin (CCK) (plasma biomarker)
Time frame: 4 hours
glucagon-like peptide-1 (GLP-1) (plasma biomarker)
Time frame: 4 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2021.
- 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.
Bev Muhlhausler, BSc(Hons) PhD principal investigator
Commonwealth Scientific and Industrial Research Organisation, Australia
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Plant-based mince and Beef mince in people with Healthy Participants, run by Commonwealth Scientific and Industrial Research Organisation, Australia.
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 6 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Brooke S Wymond, BNutrDiet(Hons) (+61 8 8303 8856, brooke.wymond@csiro.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Energy (kJ) consumed in test meals (time frame: 3 hours). 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?
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 6 Jul 2021; AzTrials last refreshed its copy on 2 Nov 2026.