Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001081505
Ethics application status
Approved
Date submitted
19/08/2024
Date registered
6/09/2024
Date last updated
6/09/2024
Date data sharing statement initially provided
6/09/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
The relationship between diet composition of grazing cattle and metabolism of human consumers
Scientific title
The impact of consuming beef derived from cattle grazing three different pasture mixes on post-postprandial metabolomic profiles in adults with cardiometabolic risk factors
Secondary ID [1] 312736 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inflammation 334765 0
Venous metabolomic profile 335001 0
Condition category
Condition code
Diet and Nutrition 331326 331326 0 0
Other diet and nutrition disorders
Cardiovascular 331515 331515 0 0
Other cardiovascular diseases
Inflammatory and Immune System 331516 331516 0 0
Other inflammatory or immune system disorders
Metabolic and Endocrine 331517 331517 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Thirty rising two-year old, Angus cattle grazed and were finished on three different pasture treatments between October and January of 2021 (n = 10 per treatment). Pasture treatments consisted of a standard perennial ryegrass and white clover pasture, a complex multi species-mixture of 24 plant species, or adjacent mono-cultures of five plant species (plantain, perennial ryegrass, lucerne, red clover, and chicory) in which all plant species were available for grazing at all times. Cattle grazed treatment pastures over 4 months and were processed at a commercial abattoir. The eye fillet (posas major) was removed from each animal, minced, homogenised by treatment, and made into patties. Twenty four (8 per pasture treatment) otherwise healthy, adults were recruited with at least 1 cardiometabolic risk factor (obese, hypertension, pre-diabetic, or hyperlipidaemia).
Using a randomised 3-way cross over design participants consumed three meals (separated by a one week washout period). Each meal consisted of 100% beef which was produced from three pasture mixtures. Measurements of postprandial (at 0, 3, and 5 hours post-meal) metabolic, inflammatory and cardiovascular health were collected immediately prior (0-hours) and following the consumption of ~ 350 g of beef (3 and 5 hours postprandial). Participants were given a meal of pasta (up to 250 g) and a vegan basil pesto (50 g) the night prior to each visit, after consumption of this meal (9 pm) they were asked to fast.
Resting venous blood samples were collected by a registered nurse from the antecubital vein using standard guidelines.
Participants arrived 30 minutes prior to meal consumption at the laboratory each week on the same day for three consecutive weeks. Following the collection of baseline (0 h) measurements they were offered 500 g of beef and given up to 15 minutes to complete their meal and they remained onsite and fasted with free access to water for 5 hours until collection of the final samples. Research staff and a registered nurse were onsite for the entirety of the measurement collection period to ensure participants fasted and adhered the research guidelines. The total amount of meat consumed was measured
The laboratory was located at the Lincoln University Sport and Exercise Science Laboratory, Canterbury, New Zealand.

Intervention code [1] 329261 0
Treatment: Other
Comparator / control treatment
The control treatment consisted of beef patty (100% beef) produced from cattle that grazed a standard ryegrass-based pasture.
Control group
Active

Outcomes
Primary outcome [1] 339089 0
Post-postprandial semi-polar metabolite profiles
Timepoint [1] 339089 0
0, 3, and 5 hours postprandial at each study visit
Primary outcome [2] 339258 0
Central metabolism of consumers of beef
Timepoint [2] 339258 0
0, 3, and 5 hours postprandial at each study visit
Primary outcome [3] 339261 0
lipidomic profiles of human consumers of beef
Timepoint [3] 339261 0
0, 3, and 5 hours postprandial at each study visit
Secondary outcome [1] 438504 0
C-reactive protein (CRP) in human consumers of beef
Timepoint [1] 438504 0
0, 3, and 5 hours postprandial at each study visit

Eligibility
Key inclusion criteria
Twenty four (8 per pasture treatment) otherwise healthy, adults were recruited with at least 1 cardiometabolic risk factor (obese, hypertension, pre-diabetic, hyperlipidaemia). Participants of this study were screened and selected for cardio-metabolic disorders containing at least one of the following:
1. Waist circumference greater than 102 cm (male), and 89 cm (female)
2. Fasting venous glucose exceeds 100mg/dL and or non-fasting haemoglobin A1c of are equal to or greater than 50 mmol/mol or pharmacological treatment
3. Fasting Triglyceride greater than 150 mg/dL or pharmacological treatment
4. Fasting High-density lipoprotein greater than 40 mg/dL (male), <50 mg/dL (female) or pharmacological treatment
5. Systolic BP greater than 130 mmHg or greater than 85 mmHg Diastolic or pharmacological treatment
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants were excluded if they had any additional health conditions that would impact the results, or if they were below or above the minimum and maximum age range (18-70 yrs). Participants with at least one cardio metabolic disease were prioritised and must have doctor's approval to participate in the experiment.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Each treatment was labelled 1, 2, or 3, only the project manager was aware of which treatment each of these referred to.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequences were generated using an excel random number generator to ensure all participants received each treatment in a random sequence but all treatments had to be cooked at least once within each phase (or day)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A minimum of 24 participants for each 3 x 3 crossover experiment resulted in 24 replications per treatment. Assuming an error rate of 0.05 and a type II error rate 0.20, a standard deviation of 13.922, the true minimum difference of interest is 11.5%.

Measurements of cardiovascular function and circulating concentrations of blood metabolites (glucose, CRP, cholesterol, high-density lipoprotein: HDL, and low-density lipoprotein: LDL) were tested for normality, and treatment effects were evaluated using either linear-mixed models or generalised-linear mixed-models using the lme4 package in R studio. Regression models were developed using treatment, time of sampling, sex, order of treatment eaten and their interactions as fixed effects, while individual nested within the day of sampling were considered as the random effect. The significance of univariate statistics was determined if P < 0.05 and tendencies were denoted as P < 0.1 and > 0.05.
Statistical analyses of peak intensities were performed in Metaboanalyst (v.5.0, https://www.metaboanalyst.ca/). Peak intensities were log-transformed (base 10) and normalized by the median of each dataset. Plant and beef metabolomic and lipidomics were assessed using a one-way ANOVA. Plasma metabolomics was analysed using a combination of two-way ANOVA to evaluate time-series data (treatment × time interactions), and linear models to account for random error of individual people and to enable covariate analysis (sex, age, body mass index, amount of beef consumed).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/04/2022
Date of last participant enrolment
Anticipated
Actual
25/05/2022
Date of last data collection
Anticipated
Actual
20/06/2022
Sample size
Target
24
Accrual to date
Final
23
Recruitment outside Australia
Country [1] 26519 0
New Zealand
State/province [1] 26519 0
Canterbury

Funding & Sponsors
Funding source category [1] 317169 0
Commercial sector/Industry
Name [1] 317169 0
Silver Fern Farms Ltd
Country [1] 317169 0
New Zealand
Funding source category [2] 317213 0
University
Name [2] 317213 0
Lincoln University
Country [2] 317213 0
New Zealand
Funding source category [3] 317214 0
Commercial sector/Industry
Name [3] 317214 0
Fertiliser NZ Ltd.
Country [3] 317214 0
New Zealand
Funding source category [4] 317215 0
Commercial sector/Industry
Name [4] 317215 0
Craigmore Sustainables Ltd
Country [4] 317215 0
New Zealand
Primary sponsor type
University
Name
Lincoln University
Address
Country
New Zealand
Secondary sponsor category [1] 319432 0
None
Name [1] 319432 0
Address [1] 319432 0
Country [1] 319432 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315913 0
Lincoln University Human Ethics Committee
Ethics committee address [1] 315913 0
Ethics committee country [1] 315913 0
New Zealand
Date submitted for ethics approval [1] 315913 0
10/08/2021
Approval date [1] 315913 0
24/01/2022
Ethics approval number [1] 315913 0
HEC2021-36

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 136198 0
Dr Anita Fleming
Address 136198 0
PO Box 85084, Lincoln University Lincoln 7647, Christchurch.
Country 136198 0
New Zealand
Phone 136198 0
+64 0221679016
Fax 136198 0
Email 136198 0
[email protected]
Contact person for public queries
Name 136199 0
Anita Fleming
Address 136199 0
PO Box 85084, Lincoln University Lincoln 7647, Christchurch.
Country 136199 0
New Zealand
Phone 136199 0
+64 0221679016
Fax 136199 0
Email 136199 0
[email protected]
Contact person for scientific queries
Name 136200 0
Pablo Gregorini
Address 136200 0
PO Box 85084, Lincoln University Lincoln 7647, Christchurch.
Country 136200 0
New Zealand
Phone 136200 0
+64021851250
Fax 136200 0
Email 136200 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The information will be kept private to maintain participant confidentiality


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.