Sustained Meat and Alternative Intake (PRotEin DIet SatisfacTION Trial 4) (PREDITION)

NCT04869163 | Completed DMC

• 1 other identifier: 5000927-4
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction The trend of flexitarian eating patterns is on the rise, with young adults amongst the biggest adopters claiming health and environmental reasons to reduce red meat intake. Nutrient dense meat and animal products are often the lynchpin of these diets, even when consumed only occasionally and in moderate amounts. Red meat provides forms and concentrations of essential proteins, lipids, and micronutrients that are scarce in exclusively vegetarian regimens. The aim of this investigation is to consider the effects of moderate consumption of lean red meat as part of an otherwise vegetarian balanced diet and its impact on biomarkers of sustained health and wellbeing. Methods and analyses A cohort of healthy, young (20-34 years) male and female participants will take part in two-arm parallel, randomised-controlled trial for a duration of 12 weeks, with a 3-month post follow-up. The trial will commence with a two-week assessment period followed by allocation to the intervention arms. The intervention will include the consumption of red meat or meat-alternatives three times per week for 10 weeks. Blood samples of the participants will be measured for changes in erythrocyte fatty acid distribution, circulating amino acids, neurotransmitters, markers of mineral status and inflammatory markers. Questionnaires to assess wellbeing and mental health will be undertaken every two weeks. Body composition, physical function test, blood measurements will be assessed at allocation (t0), week five into the intervention (t5) and post intervention (t10). Discussion To our knowledge this is the first randomised controlled trial (RCT) investigating the overarching health consequences of consuming NZ pasture fed red meat or no meat, as part of a healthy diet. Ethics and dissemination The trial was approved by the New Zealand Ministry of Health's Health and Disability Ethics Committees (20/STH/157).

Conditions

Well-being

Keywords

nutrition; meat; mental health

Outcome Measures

Primary Outcomes (1)

• Polyunsaturated fatty acids

  Concentrations of polyunsaturated fatty acids (18:2 n-6, 18:3 n-3, 20:4 n-6, 20:5 n-3, 22:5 n-3, 22:6 n-3) in erythrocyte membranes

  Baseline to 10 week comparison

Secondary Outcomes (4)

• Psychological and mental wellbeing

  Change from baseline to 10 week comparison

• Psychological and mental wellbeing

  Change from baseline to 10 week comparison

• Psychological and mental wellbeing

  Change from baseline to 10 week comparison

• Psychological and mental wellbeing

  Change from baseline to 10 week comparison

Study Arms (2)

red meat consumers

ACTIVE COMPARATOR

Consumes red meat 3 times a week

Other: Non-red meat

non-red meat consumers

EXPERIMENTAL

Consumes a non-red meat comparison product 3 times a week

Other: Non-red meat

Interventions

Non-red meat OTHER

Red meat analogues and alternatives

non-red meat consumers; red meat consumers

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• All participants are required to be omnivores who in the last 2 months consumed at least 2-3 meals per week containing meat of any description (red or white fleshed meat, including fish).
• All participants must be willing to consume both red meat and meat-analogues for the purposes of the trial.

You may not qualify if:

• Obesity (BMI ≥ 30 kg/m2),
• Hyperlipidaemia
• Anosmia and ageusia (issues with smell and taste),
• Use of medications (except for occasional NSAIDs and antihistamines) or recreational drugs, or who smoke tobacco
• Disordered eating

Sponsors & Collaborators

• University of Auckland, New Zealand: lead
• AgResearch: collaborator
• University of Otago: collaborator

Study Sites (1)

The University of Auckland

Auckland, [other], 1142, New Zealand

Location

Related Publications (3)

• Worthington A, Gillies N, Hannaford R, Roy R, Braakhuis A. Implementing multicomponent, eHealth-based behaviour change support within a dietary intervention trial improves adherence to study-related behaviours in healthy young adults. BMC Nutr. 2023 Nov 21;9(1):134. doi: 10.1186/s40795-023-00798-7.

  PMID: 37990250 DERIVED

• Gillies NA, Worthington A, Li L, Conner TS, Bermingham EN, Knowles SO, Cameron-Smith D, Hannaford R, Braakhuis A. Adherence and eating experiences differ between participants following a flexitarian diet including red meat or a vegetarian diet including plant-based meat alternatives: findings from a 10-week randomised dietary intervention trial. Front Nutr. 2023 Jun 14;10:1174726. doi: 10.3389/fnut.2023.1174726. eCollection 2023.

  PMID: 37388633 DERIVED

• Braakhuis A, Gillies N, Worthington A, Knowles S, Conner T, Roy R, Pham T, Bermingham E, Cameron-Smith D. A Modern Flexitarian Dietary Intervention Incorporating Web-Based Nutrition Education in Healthy Young Adults: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2021 Dec 21;10(12):e30909. doi: 10.2196/30909.

  PMID: 34931994 DERIVED

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 18, 2021
• First Posted: May 3, 2021
• Study Start: May 17, 2021
• Primary Completion: December 22, 2021
• Study Completion: September 30, 2022
• Last Updated: November 28, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Data will be made available when he study is complete (July 2022)

Locations

NZ (1)