NCT04545398

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2020

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 11, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2021

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2021

Completed
Last Updated

November 28, 2023

Status Verified

November 1, 2023

Enrollment Period

3 months

First QC Date

May 12, 2020

Last Update Submit

November 27, 2023

Conditions

Keywords

proteinamino aciddiethealthmeat productsbioavailability

Outcome Measures

Primary Outcomes (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

    Change from baseline to 240-minutes post meal ingestion

Secondary Outcomes (7)

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

    Change from baseline to 240-minutes post meal ingestion

  • Amino acids/ Neurotransmitters

    Change from baseline to 240-minutes post meal ingestion

  • Glucose/ Insulin

    Change from baseline to 240-minutes post meal ingestion

  • Minerals/ Iron

    Change from baseline to 240-minutes post meal ingestions

  • Fullness

    Change from baseline to 240-minutes post meal ingestion

  • +2 more secondary outcomes

Study Arms (4)

Pasture-raised

EXPERIMENTAL

The meal contains grass/pasture fed beef

Other: Food. Beef, Pasture-raised

Grain-fed

EXPERIMENTAL

The meal contains grain-fed beef

Other: Food. Beef, Grain-fed

Meat Alternative

PLACEBO COMPARATOR

The meal contains a meat alternative

Other: Food. Meat alternative

Lamb

EXPERIMENTAL

The meal contains lamb

Other: Food, Lamb

Interventions

Pasture-raised beef

Pasture-raised

Grain-fed beef

Grain-fed

Meat alternative

Meat Alternative

Lamb

Lamb

Eligibility Criteria

Age20 Years - 34 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsSelf reported gender is acceptable
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Auckland

Auckland, [other], 1142, New Zealand

Location

Related Publications (9)

  • 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.

    BACKGROUND
  • 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.

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

    BACKGROUND
  • 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.

    PMID: 32002221BACKGROUND
  • 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.

    PMID: 27128451BACKGROUND
  • 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.

    PMID: 29898882BACKGROUND
  • 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.

    PMID: 29963555BACKGROUND
  • 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.

  • 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.

MeSH Terms

Conditions

Disease

Interventions

FoodRed Meat

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet, Food, and NutritionPhysiological PhenomenaFood and BeveragesMeat

Study Officials

  • Andrea J Braakhuis, PhD

    The University of Auckland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 12, 2020

First Posted

September 11, 2020

Study Start

November 1, 2020

Primary Completion

January 30, 2021

Study Completion

December 20, 2021

Last Updated

November 28, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will share

As yet there is no plan but we are open to sharing the data

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
Pre-recruitment
Access Criteria
The study protocol will be freely available via publication

Locations