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

November 27, 2023 updated by: Dr Andrea Braakhuis, University of Auckland, New Zealand

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.

Study Overview

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).

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • [other]
      • Auckland, [other], New Zealand, 1142
        • The University of Auckland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 34 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pasture-raised
The meal contains grass/pasture fed beef
Pasture-raised beef
Experimental: Grain-fed
The meal contains grain-fed beef
Grain-fed beef
Placebo Comparator: Meat Alternative
The meal contains a meat alternative
Meat alternative
Experimental: Lamb
The meal contains lamb
Lamb

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Chylomicron fatty acids, blood test
Change from baseline to 240-minutes post meal ingestion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fatty acids (14:0, 16:0, 16:1 n-7, 18:0, 18:1 n-9, others)
Time Frame: Change from baseline to 240-minutes post meal ingestion
Chylomicron fatty acids, blood test
Change from baseline to 240-minutes post meal ingestion
Amino acids/ Neurotransmitters
Time Frame: Change from baseline to 240-minutes post meal ingestion
blood test
Change from baseline to 240-minutes post meal ingestion
Glucose/ Insulin
Time Frame: Change from baseline to 240-minutes post meal ingestion
Blood test
Change from baseline to 240-minutes post meal ingestion
Minerals/ Iron
Time Frame: Change from baseline to 240-minutes post meal ingestions
Blood test
Change from baseline to 240-minutes post meal ingestions
Fullness
Time Frame: Change from baseline to 240-minutes post meal ingestion
Questionnaire (8 questions), Likert scale, non-directional answers
Change from baseline to 240-minutes post meal ingestion
Digestive Symptoms
Time Frame: Change from baseline to 240-minutes post meal ingestion
Questionnaire (11 questions), Likert scale, higher score indicative of greater symptoms
Change from baseline to 240-minutes post meal ingestion
Meal Palatability
Time Frame: Difference between intervention meals, 30 minutes post meal
Questionnaire (5 questions), Likert scale, higher score indicative of greater palatability
Difference between intervention meals, 30 minutes post meal

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Andrea J Braakhuis, PhD, The University of Auckland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2020

Primary Completion (Actual)

January 30, 2021

Study Completion (Actual)

December 20, 2021

Study Registration Dates

First Submitted

May 12, 2020

First Submitted That Met QC Criteria

September 3, 2020

First Posted (Actual)

September 11, 2020

Study Record Updates

Last Update Posted (Actual)

November 28, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 5000927
  • U1111-1244-9426 (Registry Identifier: Universal Trial Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing Time Frame

Pre-recruitment

IPD Sharing Access Criteria

The study protocol will be freely available via publication

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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