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

NCT04869163 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2023-11-28

No results posted yet for this study

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

Interventions

OTHER

Non-red meat

Red meat analogues and alternatives

Sponsors & Collaborators

  • AgResearch

    collaborator UNKNOWN

  • University of Otago

    collaborator OTHER

  • University of Auckland, New Zealand

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-17
Primary Completion
2021-12-22
Completion
2022-09-30

Countries

  • New Zealand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04869163 on ClinicalTrials.gov