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Diet, HealthyPREDITIONNCT04545398

Acute Meat and Alternative Intake (PRotEin DIet SatisfacTION Trial 3)

A study testing Food. Beef, Pasture-raised, Food. Beef, Grain-fed and Food. Meat alternative in people with Diet, Healthy and Protein; Disease, run by University of Auckland, New Zealand at 1 site in New Zealand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Introduction: Protein rich foods that are alternatives to farm-grown meat have received considerable consumer attention. Whilst meat alternatives were once niche food products aimed at vegetarians, they are increasingly marketed to omnivores and "flexitarians", thus contributing to a trend for reductions in red meat… Read more about this study

Who is it for?
Ages 20 to 34 years, men onlyHealthy volunteers can take part
Conditions the study is for
Diet, Healthy, Protein; Disease
What is being tested?
Food. Beef, Pasture-raised, Food. Beef, Grain-fed and Food. Meat alternative
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteNew Zealand
Study dates
1 Nov 2020to 20 Dec 2021
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 34 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • All participants will be required to be omnivores willing to consume both red meat and plant-base alternatives for the purposes of the trial.

Who cannot join

  • Those with chronic health conditions, hyperlipidaemia, obesity (BMI ≥ 30), use of medications (except occasional use of NSAIDs and antihistamines), history of anosmia and ageusia (issues with taste and smell), current dieting or disordered eating pattern and smoking tobacco or recreational drugs will be excluded from participating.
  • Participants will be asked to complete an on-line screening which will include the Three-factor Eating Questionnaire-R18 (TFEQ) and a health survey. Participants with a TFEQ score greater than 75% will be excluded from participating on the basis their perception of food is potentially influenced by underlying psychological issues

Trial locations and contacts

1 site in 1 country.

New Zealand1 site
  • The University of Auckland

    Auckland, [other], 1142

Other trials in New Zealand

About this study

Official title: Acute Evidence of Digestive, Metabolic and Nutritional Differences in Beef and Meat- Analogue Meals

Introduction: Protein rich foods that are alternatives to farm-grown meat have received considerable consumer attention. Whilst meat alternatives were once niche food products aimed at vegetarians, they are increasingly marketed to omnivores and "flexitarians", thus contributing to a trend for reductions in red meat intakes [1]. Studies to date have addressed the environmental benefit, plus consumer perceptions and acceptability of meat alternatives [2, 3, 4], yet there is surprisingly a paucity of data compared the nutritional and digestive differences to meat. The aim of this trial is to compare the digestive consequences of pasture-fed and grain-finished, beef versus a plant-based meat analogue blinded meal.

Methods and analyses: Healthy, young (20-34 y) participants will be asked to consume three separate meals in a crossover, blinded investigation followed by five hours of blood testing and questionnaires to assess the digestive consequences of meat and a plant-based meat analogue. The three meals will include either pasture-fed, or grain-finished, or laboratory based protein alternative as a mixed meal, in random order, separated by one week minimum. Plasma samples will be assessed amino acid content, neurotransmitter proteins, chylomicron fatty acid distribution and general health indices.

Ethics and dissemination: The trial has been granted ethical approval by the Ministry of Health, Health and Disability Ethics Committee (Ref: 19/STH/226). All results originating from this study will be submitted for publication in scientific journals and presented at meetings.

Read the detailed description

Introduction: Red meat consumption contributes important nutrients to the diet, including essential amino acids, long chain and complex lipids, vitamins (including B12) and minerals (including iron and zinc) [5]. While supplying these important nutrients, red meat may contain components which may negate optimal health such as the saturated fat content and nitrates, that are added during processing [5]. The degree to which red meat affects health is likely related to its inherent nutritional profile, the quantity consumed and any processing (e.g. nitrates or cooking techniques). Regardless, the simple notion of a complex whole-food containing single nutrients which are 'good' or 'bad' for health is now considered overly simplistic [6]. For example, to reduce heart disease, nutritional guidelines now suggest an increase in polyunsaturated fats at the expense of saturated fat, rather than a complete reduction of all fats [6].

Alongside the controversy over the health consequences of red meat, recent attention has focused on the possibility of using "plant-based" proteins as an alternative to red meat consumption. The search for meat alternatives has resulted in a sharp increase in the production of novel "plant-based" meat analogues that have been designed to replicate the taste and eating experience of red-meat. To date there are very few studies addressing the nutritional differences between traditional red meat and plant-based meat analogues, and the nutritional differences that arise due to different production systems. Given the nutritional composition of red meat is likely to be influenced by the farming and feeding practices of the animals, production procedures and end-user cooking techniques [7], these differences need to be accounted for in the research design and application.

Aims: To investigate the digestive responses to an acute intake of pasture-fed beef, grain-finished beef, lamb and a plant based meat-analogue consumed as a component of a mixed meal. This study is part of a larger programme to understand the nutritional implications of consuming New Zealand, pasture-fed red meat as part of a balanced diet.

Study Design and Setting: The study is designed as randomised cross-over trial to capture biological difference in postprandial nutrient dynamics. Research subjects will act as their own controls and will consume each meal (pasture raised, grain-fed beef, lamb and a meat alternative meal) on a separate occasion in random order. The study compares exemplars of pasture-fed New Zealand beef, grain-finished New Zealand beef, lamb and a meat analogue. The plant-based meat analogue has been selected on the basis of its macronutrient profile (protein and fat) and appearance in order to that best matches that of meat.

The digestion and metabolism of key nutrients in beef will be measured immediately after the ingestion of a single meal. This experimental setting will also be used to examine some subjective qualities of the meal experience, such as satisfaction score (i.e., liking, satisfaction, enjoyment, satiety, appetite) and gastrointestinal score (i.e., comfort, fullness, bloating, rumbling, flatulence, faecal urgency, diarrhoea).

Being tested
Food. Beef, Pasture-raised, Food. Beef, Grain-fed, Food. Meat alternative, Food, Lamb
Keywords
protein, amino acid, diet, health, meat products, bioavailability
Medical subject headings
Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Food. Beef, Pasture-raisedOther

    Pasture-raised beef

  • Food. Beef, Grain-fedOther

    Grain-fed beef

  • Food. Meat alternativeOther

    Meat alternative

  • Food, LambOther

    Lamb

Study groups in NCT04545398
Study groupRoleWhat they receive
Pasture-raisedExperimentalThe meal contains grass/pasture fed beef
Receives: Other: Food. Beef, Pasture-raised
Grain-fedExperimentalThe meal contains grain-fed beef
Receives: Other: Food. Beef, Grain-fed
Meat AlternativePlacebo comparatorThe meal contains a meat alternative
Receives: Other: Food. Meat alternative
LambExperimentalThe meal contains lamb
Receives: Other: Food, Lamb

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. LCPUFA (18:2 n-6, 18:3 n-3, 20:4 n-6, 20:5 n-3, 22:5 n-3, 22:6 n-3

    Chylomicron fatty acids, blood test

    Measured: Change from baseline to 240-minutes post meal ingestion

Secondary outcomes (7)
  1. Fatty acids (14:0, 16:0, 16:1 n-7, 18:0, 18:1 n-9, others)

    Chylomicron fatty acids, blood test

    Measured: Change from baseline to 240-minutes post meal ingestion

  2. Amino acids/ Neurotransmitters

    blood test

    Measured: Change from baseline to 240-minutes post meal ingestion

  3. Glucose/ Insulin

    Blood test

    Measured: Change from baseline to 240-minutes post meal ingestion

  4. Minerals/ Iron

    Blood test

    Measured: Change from baseline to 240-minutes post meal ingestions

  5. Fullness

    Questionnaire (8 questions), Likert scale, non-directional answers

    Measured: Change from baseline to 240-minutes post meal ingestion

  6. Digestive Symptoms

    Questionnaire (11 questions), Likert scale, higher score indicative of greater symptoms

    Measured: Change from baseline to 240-minutes post meal ingestion

  7. Meal Palatability

    Questionnaire (5 questions), Likert scale, higher score indicative of greater palatability

    Measured: Difference between intervention meals, 30 minutes post meal

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2020
  2. Study start1 Nov 2020
  3. Primary completion30 Jan 2021
  4. Study completion20 Dec 2021

Resources

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
Crossover
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04545398
Sponsor's protocol ID
5000927
Other IDs
U1111-1244-9426
Acronym
PREDITION
Status last verified
Nov 2023
First submitted
12 May 2020
Last updated
28 Nov 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: As yet there is no plan but we are open to sharing the data

Publications

  • 1. Thakur A. Market for Plant-Based Meat Alternatives. Environmental, Health, and Business Opportunities in the New Meat Alternatives Market. IGI Global; 2019: 218-37.

  • Slade P. If you build it, will they eat it? Consumer preferences for plant-based and cultured meat burgers. Appetite. 2018 Jun 1;125:428-437. doi: 10.1016/j.appet.2018.02.030. Epub 2018 Mar 5.

    PubMed 29501683
  • 3. Circus VE, Robison R. Exploring perceptions of sustainable proteins and meat attachment. B Food J. 2019.

  • Keefe LM. #FakeMeat: How big a deal will animal meat analogs ultimately be? Anim Front. 2018 Jul 19;8(3):30-37. doi: 10.1093/af/vfy011. eCollection 2018 Jul. No abstract available.

    PubMed 32002221
  • Ekmekcioglu C, Wallner P, Kundi M, Weisz U, Haas W, Hutter HP. Red meat, diseases, and healthy alternatives: A critical review. Crit Rev Food Sci Nutr. 2018 Jan 22;58(2):247-261. doi: 10.1080/10408398.2016.1158148. Epub 2017 Jun 28.

    PubMed 27128451
  • Forouhi NG, Krauss RM, Taubes G, Willett W. Dietary fat and cardiometabolic health: evidence, controversies, and consensus for guidance. BMJ. 2018 Jun 13;361:k2139. doi: 10.1136/bmj.k2139.

    PubMed 29898882
  • Hicks TM, Knowles SO, Farouk MM. Global Provisioning of Red Meat for Flexitarian Diets. Front Nutr. 2018 Jun 14;5:50. doi: 10.3389/fnut.2018.00050. eCollection 2018.

    PubMed 29963555
  • Pham T, Morton L, Gillies N, Bermingham E, Knowles S, Cameron-Smith D, Braakhuis AJ. Plasma chylomicron-rich lipidomic and fatty acid profile following a meat or analog meal in healthy males: A randomized controlled trial. Am J Clin Nutr. 2025 Sep;122(3):770-779. doi: 10.1016/j.ajcnut.2025.07.010. Epub 2025 Jul 15.

    PubMed 40675490
  • Pham T, Knowles S, Bermingham E, Brown J, Hannaford R, Cameron-Smith D, Braakhuis A. Plasma Amino Acid Appearance and Status of Appetite Following a Single Meal of Red Meat or a Plant-Based Meat Analog: A Randomized Crossover Clinical Trial. Curr Dev Nutr. 2022 May 4;6(5):nzac082. doi: 10.1093/cdn/nzac082. eCollection 2022 May.

    PubMed 35669048

Questions about this trial

What is this clinical trial studying?

A study testing Food. Beef, Pasture-raised, Food. Beef, Grain-fed and Food. Meat alternative in people with Diet, Healthy and Protein; Disease, 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 1 inclusion and 2 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. Some participants in this study may receive a placebo. 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?

LCPUFA (18:2 n-6, 18:3 n-3, 20:4 n-6, 20:5 n-3, 22:5 n-3, 22:6 n-3 (time frame: Change from baseline to 240-minutes post meal ingestion). 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 NCT04545398, which also lists 9 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.

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