Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001022257
Ethics application status
Approved
Date submitted
11/06/2018
Date registered
19/06/2018
Date last updated
21/06/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Complex lipids for enhanced metabolic health
Scientific title
In middle-aged men at heightened cardiovascular disease risk, do the complex lipids in grass fed Waygu beef enhance metabolic health relative to grain fed beef or vegetarian alternatives?
Secondary ID [1] 295070 0
None
Universal Trial Number (UTN)
U1111-­1213-­8287
Trial acronym
CLIMB
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease 308115 0
Condition category
Condition code
Cardiovascular 307156 307156 0 0
Other cardiovascular diseases
Diet and Nutrition 307324 307324 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects will consume 3 times weekly for 8 weeks standard servings (167g) of either:
(1) NZ grass-fed Wagyu beef
(2) grain-fed commercial beef or
(3) vegetable-based meat alternatives
Adherence to the study protocol will monitored through questionnaires filled out in front of study personnel during fortnightly visits to the Liggins Institute.
An overnight fast (10 hours) is required of the participant immediately before the baseline visit and the post-intervention visit, including all food and drink although water is permitted. Adherence to fasting is assured by food recall and subject confirmation.

Intervention code [1] 301437 0
Treatment: Other
Comparator / control treatment
Vegetable-based meat alternative
Control group
Active

Outcomes
Primary outcome [1] 306165 0
RBC long chain omega-3 PUFA as assessed by MS-based lipidomic analysis.
Timepoint [1] 306165 0
Assessed at baseline prior to beginning the dietary intervention, and then again 8 weeks post commencement of the intervention.
Primary outcome [2] 306322 0
Plasma long chain omega-3 PUFA as assessed by MS-based lipidomic analysis.
Timepoint [2] 306322 0
Assessed at baseline prior to beginning the dietary intervention, and then again 8 weeks post commencement of the intervention.
Secondary outcome [1] 347754 0
LDL particle as assessed by nuclear magnetic resonance spectroscopy (NMR) of blood sample
Timepoint [1] 347754 0
Assessed at baseline prior to beginning the dietary intervention, and then again 8 weeks post commencement of the intervention.
Secondary outcome [2] 347755 0
Gut microbiota composition and diversity as assessed by faecal metagenomic analysis.
Timepoint [2] 347755 0
Assessed at baseline prior to beginning the dietary intervention, and then again 8 weeks post commencement of the intervention.
Secondary outcome [3] 347756 0
Circulating TMAO and its related metabolite concentrations as assessed in plasma samples using liquid chromatography/stable-isotope dilution/multiple-reaction monitoring/MS.
Timepoint [3] 347756 0
Assessed at baseline prior to beginning the dietary intervention, and then again 8 weeks post commencement of the intervention.
Secondary outcome [4] 347783 0
Faecal metabolites, including short-chain fatty acids as assessed by Gas-chromatography mass spectrometry-solid-phase microextraction (GC-MS/SPME).
Timepoint [4] 347783 0
Assessed at baseline prior to beginning the dietary intervention, and then again 8 weeks post commencement of the intervention.
Secondary outcome [5] 347785 0
Fasting plasma markers of metabolic and cardiovascular disease risk (including glucose, insulin, cholesterol, triglycerides, HbA1c) as assessed by colorimetric and enzymatic immunoassays as a composite measure..
Timepoint [5] 347785 0
Assessed at baseline prior to beginning the dietary intervention, and then again 8 weeks post commencement of the intervention.
Secondary outcome [6] 347786 0
Individual fasting plasma markers of metabolic and cardiovascular disease risk: glucose as assessed by colorimetric immunoassay.
Timepoint [6] 347786 0
Assessed at baseline prior to beginning the dietary intervention, and then again 8 weeks post commencement of the intervention.
Secondary outcome [7] 347787 0
Individual fasting plasma markers of metabolic and cardiovascular disease risk: insulin as assessed by enzymatic immunoassay.
Timepoint [7] 347787 0
Assessed at baseline prior to beginning the dietary intervention, and then again 8 weeks post commencement of the intervention.
Secondary outcome [8] 347980 0
Individual fasting plasma markers of metabolic and cardiovascular disease risk: cholesterol as assessed by colorimetric immunoassay.
Timepoint [8] 347980 0
Assessed at baseline prior to beginning the dietary intervention, and then again 8 weeks post commencement of the intervention.
Secondary outcome [9] 347981 0
Individual fasting plasma markers of metabolic and cardiovascular disease risk: triglycerides as assessed by colorimetric immunoassay.
Timepoint [9] 347981 0
Assessed at baseline prior to beginning the dietary intervention, and then again 8 weeks post commencement of the intervention.
Secondary outcome [10] 347982 0
Individual fasting plasma markers of metabolic and cardiovascular disease risk: HbA1c as assessed by colorimetric immunoassays.
Timepoint [10] 347982 0
Assessed at baseline prior to beginning the dietary intervention, and then again 8 weeks post commencement of the intervention.
Secondary outcome [11] 347983 0
Anthropometry measures including blood pressure assessed by digital oscillometer..
Timepoint [11] 347983 0
Assessed at baseline prior to beginning the dietary intervention, and then again 8 weeks post commencement of the intervention.
Secondary outcome [12] 347984 0
Anthropometry measures including weight assessed by digital scale.
Timepoint [12] 347984 0
Assessed at baseline prior to beginning the dietary intervention, fortnightly, and then again 8 weeks post commencement of the intervention.
Secondary outcome [13] 348169 0
Anthropometry measures including waist circumference assessed by non-flexible tape measure.
Timepoint [13] 348169 0
Assessed at baseline prior to beginning the dietary intervention, and then again 8 weeks post commencement of the intervention.
Secondary outcome [14] 348170 0
Anthropometry measures including body composition assessed by a dual energy x-ray absorptiometry (DXA) scan.
Timepoint [14] 348170 0
Assessed at baseline prior to beginning the dietary intervention, and then again 8 weeks post commencement of the intervention.
Secondary outcome [15] 348176 0
Fasting amino acids and metabolite profile as assessed by liquid chromatography mass spectrometry and ultra performance liquid chromatography.
Timepoint [15] 348176 0
Assessed at baseline prior to beginning the dietary intervention, and then again 8 weeks post commencement of the intervention.
Secondary outcome [16] 348177 0
Whole blood count profiles as assessed with a hematology analyser.
Timepoint [16] 348177 0
Assessed at baseline prior to beginning the dietary intervention, and then again 8 weeks post commencement of the intervention.
Secondary outcome [17] 348178 0
Peripheral blood mononuclear cell (PBMC) gene expression as assessed by RT-PCR.
Timepoint [17] 348178 0
Assessed at baseline prior to beginning the dietary intervention, and then again 8 weeks post commencement of the intervention.
Secondary outcome [18] 348179 0
Circulating inflammatory markers (cytokines) as assessed by flow cytometric multiplex array.
Timepoint [18] 348179 0
Assessed at baseline prior to beginning the dietary intervention, and then again 8 weeks post commencement of the intervention.
Secondary outcome [19] 348180 0
Urine metabolites and inflammatory markers as assessed by liquid chromatography/stable-isotope dilution/multiple-reaction monitoring/MS (exploratory).
Timepoint [19] 348180 0
Assessed at baseline prior to beginning the dietary intervention, and then again 8 weeks post commencement of the intervention.
Secondary outcome [20] 348181 0
Faecal inflammatory status as assessed by faecal markers, including secretory IgA by enzyme-linked immunosorbent assays.
Timepoint [20] 348181 0
Assessed at baseline prior to beginning the dietary intervention, and then again 8 weeks post commencement of the intervention.
Secondary outcome [21] 348182 0
Faecal inflammatory status as assessed by faecal markers, including calprotectin by enzyme-linked immunosorbent assays.
Timepoint [21] 348182 0
Assessed at baseline prior to beginning the dietary intervention, and then again 8 weeks post commencement of the intervention.
Secondary outcome [22] 348183 0
Faecal inflammatory status as assessed by faecal markers, including lipocalin by enzyme-linked immunosorbent assays.
Timepoint [22] 348183 0
Assessed at baseline prior to beginning the dietary intervention, and then again 8 weeks post commencement of the intervention.
Secondary outcome [23] 348184 0
Faecal inflammatory status as assessed by faecal markers, including myeloperoxidase (MPO) by enzyme-linked immunosorbent assays.
Timepoint [23] 348184 0
Assessed at baseline prior to beginning the dietary intervention, and then again 8 weeks post commencement of the intervention.
Secondary outcome [24] 348185 0
Faecal inflammatory status as assessed by faecal markers, including zonulin by enzyme-linked immunosorbent assays.
Timepoint [24] 348185 0
Assessed at baseline prior to beginning the dietary intervention, and then again 8 weeks post commencement of the intervention.

Eligibility
Key inclusion criteria
Subjects will be:
• Male
• 35-55 years
• BMI 25-35 kg/m2
• Total non-fasting cholesterol >5.0 mmol/L and/or LDL-C >3.0 mmol/L and/or HDL-C <1.0 mmol/L, and/or non-fasting triacylglycerides >2.0 mmol/L
• No history of heart disease, gastrointestinal disease, or metabolic disease
Minimum age
35 Years
Maximum age
55 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded from participation if they:
• Have heart, metabolic, or gastrointestinal disease
• Random blood glucose greater than 11.1 mmol/L
• Are currently taking medications for cardiovascular disease, or which are expected to interfere with normal digestive or metabolic processes including proton pump inhibitors, laxatives, etc.
- Have taken antibiotics within the preceding 3 months
• Have a medical history precluding a healthy state: history of myocardial infarction, angina, stroke, cancer or pre-existing diabetes, self-reported alcohol intake exceeding a moderate intake (>28 units per week)
• Are smokers

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)
Randomisation sequences will be computer-generated. Allocation will be implemented through sealed envelopes. Un-blinding will occur only after completion of the primary outcome analysis.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Study outcomes will be analysed on a per-protocol basis, including only those subject who successfully completed the 8 week intervention. Primary outcomes will be analysed using repeated factor generalised linear regression adjusted for multiple comparisons. Secondary outcomes will be analysed with repression models appropriate for their distributions.
Faecal microbial composition and predictive function will be analysed using R 3.1.3. Differences between mean relative abundances of taxa and predicted functions will be analysed by permutation ANOVA implemented using the RVAideMemoire package (version 0.9-45-2) in R. Adjustment of P values for multiple testing will be performed using the Benjamini & Hochberg false discovery rate (FDR) method, with FDR < 0.05 considered significant. Permutation MANOVA and Procrustes rotation analysis will be performed using the adonis and procrustes functions, respectively, as implemented in the vegan package for R. Partial least squares discriminant analysis (PLS-DA) and principal component analysis will be performed using the mixOmics package for R.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
9/07/2018
Actual
Date of last participant enrolment
Anticipated
1/06/2019
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
0
Final
Recruitment outside Australia
Country [1] 10530 0
New Zealand
State/province [1] 10530 0
Auckland

Funding & Sponsors
Funding source category [1] 299697 0
Commercial sector/Industry
Name [1] 299697 0
AgResearch Limited
Country [1] 299697 0
New Zealand
Funding source category [2] 299698 0
Commercial sector/Industry
Name [2] 299698 0
Firstlight Foods Limited
Country [2] 299698 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
AgResearch Limited
Address
Grasslands Research Centre   
Tennent Drive 
Palmerston North 
44442 
New Zealand 
Country
New Zealand
Secondary sponsor category [1] 298981 0
University
Name [1] 298981 0
University of Auckland
Address [1] 298981 0
Level 10, Building 620
49 Symonds St
Auckland
1010
Country [1] 298981 0
New Zealand
Secondary sponsor category [2] 299037 0
Commercial sector/Industry
Name [2] 299037 0
Firstlight Foods Limited
Address [2] 299037 0
PO Box 2093
Stotford Lodge
Hastings
2144
Country [2] 299037 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300550 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 300550 0
Ethics committee country [1] 300550 0
New Zealand
Date submitted for ethics approval [1] 300550 0
15/05/2018
Approval date [1] 300550 0
28/05/2018
Ethics approval number [1] 300550 0
18/STH/104

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

Contacts
Principal investigator
Name 84030 0
Prof David Cameron-Smith
Address 84030 0
The Liggins Institute
University of Auckland
Building 505
Grafton
Auckland
1023
Country 84030 0
New Zealand
Phone 84030 0
+64 9 9231336
Fax 84030 0
Email 84030 0
[email protected]
Contact person for public queries
Name 84031 0
David Cameron-Smith
Address 84031 0
The Liggins Institute
University of Auckland
Building 505
Grafton
Auckland
1023
Country 84031 0
New Zealand
Phone 84031 0
+64 9 9231336
Fax 84031 0
Email 84031 0
[email protected]
Contact person for scientific queries
Name 84032 0
David Cameron-Smith
Address 84032 0
The Liggins Institute
University of Auckland
Building 505
Grafton
Auckland
1023
Country 84032 0
New Zealand
Phone 84032 0
+64 9 9231336
Fax 84032 0
Email 84032 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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