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Trial registered on ANZCTR


Registration number
ACTRN12620000525987
Ethics application status
Approved
Date submitted
2/04/2020
Date registered
29/04/2020
Date last updated
29/04/2020
Date data sharing statement initially provided
29/04/2020
Date results information initially provided
29/04/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Inflammatory responses to meals with varying levels of anti-inflammatory potential: a randomised control pilot study in adults above a healthy weight

Scientific title
Effects of meals with varying levels of anti-inflammatory compounds on circulating cytokines in overweight and obese adults: A randomised controlled postprandial pilot study
Secondary ID [1] 300924 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postprandial inflammation 316899 0
Condition category
Condition code
Diet and Nutrition 315076 315076 0 0
Obesity
Metabolic and Endocrine 315077 315077 0 0
Diabetes
Metabolic and Endocrine 315226 315226 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study uses a randomised, controlled, cross over design where participants are randomised to one of three meal orders. Each participant will attend 1 screening visit and three testing visits, with a washout period between testing visits of no less than 1 week.

Screening visit (x 1): Participants will have their height, weight, waist circumference and blood pressure measured. Eligible participants will be given a physical activity questionnaire (IPAQ), a 3-day food diary, and two questionnaires used to explore factors that affect their food choices, to be completed prior to their first testing visit.

Pre-testing procedure: Prior to each testing session participants will be provided with a ready-prepared standardised evening meal comprised of a Healthy Choice spinach and ricotta ravioli, 50 g cheese and crackers, 250 mL 100% apple juice (3MJ, 45-65% total energy (E) carbohydrate, 25-35% E protein, and 15-25% E fat). They will be asked to consume this meal between 7 – 9 pm the night before each testing day, and will be asked to fast for 12 hours prior to their test visit. During this time they will be required to refrain from eating or drinking anything else except for water until they attend the Department of Nutrition, Dietetics & Food at the BASE Facility, Monash University, Notting Hill. They will also be asked to refrain form moderate and vigorous physical activity and alcohol consumption for 24 hours prior to each testing session. To monitor adherence to pre-intervention procedures, participants will be asked to recall at what time they consumed the standardised evening meal, how much of the standardised evening meal was consumed, and any other foods or drinks consumed during the 12 hour fasting period. They will also be asked to recall all physical activity undertaken and alcohol consumed in the 24 hour period prior to their testing visits.

Testing visits (x3): Participants will be asked to come in to the lab at 8 am in the morning following an overnight fast. Their weight and waist circumference will be taken. On the morning of each test session participants will have an indwelling catheter inserted and a baseline blood draw (~15ml taken at time point t = 0). Participants will then be provided with the relevant test meal, and will be supervised to ensure all of the meal is consumed within 15 minutes. They will then remain in the laboratory for five hours, during which time 8 additional blood draws (at time points t 15, 30, 45, 60, 120, 180, 240, 300 m) will be taken, and they will not be permitted to consume any food or drink except water. During each of these testing sessions participants will also be asked to complete 3 visual analogue scales (VAS) for hunger, desire to eat, and fullness. These three VAS scales will be completed at baseline (before consuming the test meal) and then hourly for five hours (at time points t 60, 120, 180, 240 and 300 m). Lastly, participants will be asked to undertake two questionnaires about sensory evaluation and factors affecting their likelihood to prepare each of the test meals at home. Following the final blood draw the indwelling catheter will be removed.

During the first testing visit participants will have their body composition (DXA scan) measured. The DXA scan will be performed prior to catheter insertion. A qualified dietitian will also take a detailed diet history.

Test Meals: There are three isocaloric test meals (2.2 MJ) meals designed to have a low (-6.24, termed the anti-inflammatory meal), moderate (-2.76, termed the neutral meal) or high (+9.36, termed the pro-inflammatory meal) Dietary Inflammatory Index (DII) score.

The pro-inflammatory meal, a cheese and bacon croissant, is a highly processed meal obtained from commercially available products. The neutral meal, a chicken, vegetable, red kidney bean and wholegrain pasta minestrone soup, is a typical healthy meal. The anti-inflammatory meal is an adaptation of the neutral meal, specifically designed to optimise purported anti-inflammatory compounds, including but not limited to ß-carotene, eugenol, fibre, omega-3 fatty acids, vitamin A, vitamin E and flavonoids.

The anti-inflammatory meal is the intervention meal and can be described as a chicken, vegetable and red kidney bean curry, served with brown rice, flaxseeds, and a lemon kefir yogurt (2.3 MJ, with 36% energy from carbohydrate (19 g fibre), 35% energy from fat (3.4 g saturates) and 19% energy from protein).
Intervention code [1] 317240 0
Lifestyle
Comparator / control treatment
As described in the section 'Description of intervention(s) / exposure', all three test meals (control and intervention) assessments are identical.

The control meal (pro-inflammatory meal), a cheese and bacon croissant, is matched for energy against the anti-inflammatory meal but otherwise has a vastly different nutritional composition (2.3 MJ, with 19% energy from carbohydrate (2 g fibre), 64% energy from fat (20 g saturates) and 17% energy from protein).
Control group
Active

Outcomes
Primary outcome [1] 323373 0
Plasma IL-6 (incremental area under the curve) will be assessed from blood samples (venous blood) after all three meals.
Timepoint [1] 323373 0
Five hour IL-6 iAUC will be calculated from venous blood samples at six time points (0, 60, 120, 180, 240, 300 m) after all three test meals. Calculation of the iAUC takes into account all time points.
Primary outcome [2] 323379 0
Plasma IL-1ß (incremental area under the curve) will be assessed from blood samples (venous blood) after all three test meals.
Timepoint [2] 323379 0
Five hour IL-1ß iAUC will be calculated from venous blood samples at six time points (0, 60, 120, 180, 240, 300 m) after all three test meals. Calculation of the iAUC takes into account all time points.
Primary outcome [3] 323380 0
Plasma TNF-a (incremental area under the curve) will be assessed from blood samples (venous blood) after all three test meals.
Timepoint [3] 323380 0
Five hour TNF-a iAUC will be calculated from venous blood samples at six time points (0, 60, 120, 180, 240, 300 m) after all three test meals. Calculation of the iAUC takes into account all time points.
Secondary outcome [1] 381709 0
Plasma IL-10 (incremental area under the curve) will be assessed from blood samples (venous blood) after all three test meals.
Timepoint [1] 381709 0
Five hour IL-10 iAUC will be calculated from venous blood samples at six time points (0, 60, 120, 180, 240, 300 m) after all three test meals. Calculation of the iAUC takes into account all time points.
Secondary outcome [2] 382025 0
Glucose (incremental area under the curve) will be assessed from blood samples (venous blood) after all three test meals.
Timepoint [2] 382025 0
Three hour glucose iAUC will be calculated from venous blood samples at five time points (0, 30, 60, 120, 180 m) after after all three test meals, Calculation of the iAUC takes into account all time points.
Secondary outcome [3] 382026 0
Insulin (incremental area under the curve) is assessed from blood samples (venous blood) after all three test meals.
Timepoint [3] 382026 0
Three hour insulin iAUC (minutes) will be calculated from venous blood samples at five time points (0, 30, 60, 120, 180 m) after all three test meals. Calculation of the iAUC takes into account all time points.
Secondary outcome [4] 382027 0
Triglycerides (TAGS) (incremental area under the curve) is assessed from blood samples (venous blood) after all three test meals.
Timepoint [4] 382027 0
Five hour TAGS iAUC (minutes) will be calculated from venous blood samples at six time points (0, 60, 120, 180, 240, 300 m) after all three test meals. Calculation of the iAUC takes into account all time points.
Secondary outcome [5] 382028 0
Total cholesterol (TC) (incremental area under the curve) is assessed from blood samples (venous blood) after all three test meals.
Timepoint [5] 382028 0
Five hour TC iAUC (minutes) will be calculated from venous blood samples at six time points (0, 60, 120, 180, 240, 300 m) after all three test meals. Calculation of the iAUC takes into account all time points.
Secondary outcome [6] 382029 0
Subjective measures of appetite (total area under the curve) will be assessed using visual analogue scales for hunger, desire to eat and fullness after all three test meals.
Timepoint [6] 382029 0
Fivre hour subjective measures of appetite for hunger, desire to eat and fullness tAUC will be calculated from VAS taken at six time points (0, 60, 120, 180, 240 and 300 minutes) after all three test meals.

Eligibility
Key inclusion criteria
Eligible participants were men > 50 and < 75 years or post-menopausal women, with a body mass index (BMI) > 25 kg/m2.
Minimum age
50 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Diagnosis of a chronic disease (such as CVD or T2DM), known allergies/intolerances to study foods, loss of > 10% total body weight in the 6 months preceding the study, smokers, history of drug or alcohol addiction, and use of anti-inflammatory medications such as aspirin, steroids or non-steroidal anti-inflammatory drugs.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Data will be presented as total area under the curve (tAUC) for VAS data and incremental area under the curve (iAUC) for biochemical data. Inflammatory markers, lipids and VAS data will be calculated over a five hour period (0 to 300 minutes), whereas the iAUC for glucose and insulin will be assessed over a three hour period (0 to 180 minutes). Incremental AUC will be calculated using the trapezoid rule, which ignores the area beneath the baseline concentration.

P< 0,05 will be taken as significant.

Statistical analyses will be performed using SPSS software package for Windows (version 24.0; IBM Corporation, New York, USA). Due to the small sample size, during statistical analysis all data will be treated as non-parametric, and will be reported as median (interquartile range). Friedman test followed by pairwise comparisons using Wilcoxon signed-rank test will be used to make comparisons between the three test meals, for iAUC glucose, insulin, lipids and inflammatory markers, and tAUC VAS data. Wilcoxon signed-rank test will be used to compare peak concentrations with baseline concentrations for inflammatory markers. Mann-Whitney U test will be used to compare measures between male and female participants.

Post-hoc power calculations will be conducted, and will compare iAUC for IL-6, IL-1ß, IL-10 and TNF-a using 80% power at an alpha value of 0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 29813 0
3168 - Notting Hill

Funding & Sponsors
Funding source category [1] 305371 0
University
Name [1] 305371 0
Monash University
Address [1] 305371 0
Wellington Road Clayton VIC, 3800
Country [1] 305371 0
Australia
Primary sponsor type
Individual
Name
Dr Aimee Dordevic
Address
Department of Nutrition, Dietetics and Food
Monash University
Level 1
264 Ferntree Gully Road
Notting HIll
VIC
3168
Country
Australia
Secondary sponsor category [1] 305754 0
None
Name [1] 305754 0
Address [1] 305754 0
Country [1] 305754 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305701 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 305701 0
First Floor, Room 111
Chancellery Building E
24 Sports Walk
Monash Research Office
Clayton Campus
Monash University VIC 3800
Ethics committee country [1] 305701 0
Australia
Date submitted for ethics approval [1] 305701 0
29/03/2017
Approval date [1] 305701 0
04/12/2017
Ethics approval number [1] 305701 0
Project Number: 8773

Summary
Brief summary
Reduction in subclinical inflammation is a potential target for chronic disease prevention, and pro-inflammatory effects of foods are observed following consumption of a single high fat meal. However, there is no consensus regarding inflammatory mediators that best characterise postprandial inflammatory responses. There are also few studies which account for the complex nutritional matrix that exists at mealtimes. Therefore, this study aims to identify whether plasma IL-6, IL-1ß, TNF-a and IL-10, the most commonly measured inflammatory mediators in postprandial research, are appropriate outcomes measures in postprandial protocols comparing acute inflammatory effects of mixed meals. In a randomised controlled, crossover design, 12 adults aged between 50 and 75 years, who are above a healthy weight, will consume three isocaloric (2.2 MJ) meals designed to have a low (-6.24), moderate (-2.76) or high (+9.36) Dietary Inflammatory Index (DII) score, after an overnight fast. Fasting and postprandial blood samples will be collected over five hours and analysed for plasma IL-6, IL-1ß, TNF-a and IL-10. Post-hoc power calculations will be used for future research, to identify appropriate outcome measures, that can be used to perform sample size calculations for larger fully-powered studies. To aid the interpretation of inflammatory responses, this study will also assess differences on postprandial glucose, insulin, lipids and subjective measures of appetite between the three test meals.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 101282 0
Dr Aimee Dordevic
Address 101282 0
Department of Nutrition and Dietetics
Monash University
264 Ferntree gully Road
Notting Hill
VIC 3168
Country 101282 0
Australia
Phone 101282 0
+61 39905 2142
Fax 101282 0
Email 101282 0
aimee.dordevic@monash.edu
Contact person for public queries
Name 101283 0
Ms Stephanie Cowan
Address 101283 0
Department of Nutrition and Dietetics
Monash University
264 Ferntree gully Road
Notting Hill
VIC 3168
Country 101283 0
Australia
Phone 101283 0
+61 39902 4534
Fax 101283 0
Email 101283 0
stephanie.cowan@monash.edu
Contact person for scientific queries
Name 101284 0
Ms Stephanie Cowan
Address 101284 0
Department of Nutrition and Dietetics
Monash University
264 Ferntree gully Road
Notting Hill
VIC 3168
Country 101284 0
Australia
Phone 101284 0
+61 39902 4534
Fax 101284 0
Email 101284 0
stephanie.cowan@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Only individual data underlying published results will be shared and this data will only de-identified data will be shared.
When will data be available (start and end dates)?
Data will be made available immediately following publication and there is no end date.
Available to whom?
We will only share this data with researchers who provide a methodologically sound proposal for accessing the data and this will be assessed on a case-by-case basis at the discretion of the research team.
Available for what types of analyses?
There is no limit to the types of analyses that can be undertaken with shared data.
How or where can data be obtained?
Access to the data will be subject to approvals by the Principal Investigator (Dr Aimee Dordevic, email aimee.dordevic@monash.edu)
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – plain English summary
Reduction in subclinical inflammation is a potential target for chronic disease prevention, and pro-inflammatory effects of foods are observed following consumption of a single high fat meal. This study explores whether manipulation of the anti-inflammatory potential of meals, using the Dietary Inflammatory Index (DII), alters postprandial levels of circulating inflammatory markers (plasma levels of IL-6, IL-1ß, TNF-a and IL-10) in adults above a healthy weight. In a randomised controlled, crossover design, 12 adults aged between 50 and 75 years, who were above a healthy weight, consumed three meals that were matched for energy (2.2 MJ) and designed to have a low (-6.24), moderate (-2.76) or high (+9.36) Dietary Inflammatory Index (DII) score, after an overnight fast. Fasting and postprandial blood samples were collected over five hours and analysed for IL-6, IL-1ß, TNF-a and IL-10. Postprandial changes in these measured inflammatory markers were not different between the three test meals.