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

Diet, Healthy Clinical Trial

— PREDITION  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04545398
• Other study ID #: 5000927
• Secondary ID: U1111-1244-9426
• Status: Completed
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: December 20, 2021

Study information

• Verified date: November 2023
• Source: University of Auckland, New Zealand
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 20, 2021
• Est. primary completion date: January 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 34 Years

Eligibility

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

Related Conditions & MeSH terms

• Diet, Healthy
• Protein; Disease

Intervention

Other:
• Food. Beef, Pasture-raised
Pasture-raised beef
• Food. Beef, Grain-fed
Grain-fed beef
• Food. Meat alternative
Meat alternative
• Food, Lamb
Lamb

Locations

Country	Name	City	State
New Zealand	The University of Auckland	Auckland	[other]

Sponsors (5)

Lead Sponsor	Collaborator
University of Auckland, New Zealand	AgResearch, Massey University, Singapore Institute for Clinical Sciences, The Riddet Institute

Country where clinical trial is conducted

New Zealand, 

References & Publications (7)

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.

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

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