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Trial registered on ANZCTR


Registration number
ACTRN12618001115224
Ethics application status
Approved
Date submitted
29/06/2018
Date registered
5/07/2018
Date last updated
5/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Metabolic responses to night-time eating: a randomised control trial in men with high fasting lipids
Scientific title
Metabolic responses to night-time eating: a randomised control trial in men with high fasting lipids
Secondary ID [1] 288287 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postprandial lipaemia 297326 0
Postprandial glycaemia 297327 0
Condition category
Condition code
Diet and Nutrition 297520 297520 0 0
Other diet and nutrition disorders
Metabolic and Endocrine 307598 307598 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants are required to undertake 2 overnight assessments (midnight to 6am) at the Be Active Sleep eat Facility BASE) at Monash University, Notting Hill. Prior to the first assessment participants are screened to ensure they meet eligibility criteria, anthropometric measurements are taken (height, weight and body composition), blood pressure and if deemed eligible asked to keep a 7 day food diary, sleep diary and wear an activity monitor for the same 7 day period prior to the first assessment. Participants are also required to complete a Medical and lifestyle history questionnaire to assess eligibility, Pittsburg Sleep Quality Index (PSQ1) to assess sleep habits over the last month and Morningness-Eveningness Questionnaire (MEQ) to assess whether the participants circadian rhythm produces peak alertness in the morning, in the evening, or in between.

At 1200h and 1800h on the assessment days, subjects will be required to consume control meals and snacks for lunch and dinner (2636kJ, 29.4% protein, 49% carbohydrate, 32% fat and 1,288kJ, 14% protein, 66% carbohydrates and 15% fat, respectively). All control meals and snacks are to be consumed within 15 minutes. Subjects will then refrain from eating or drinking anything else (except for water) until they come into the BASE Facility for the night-time assessment.

Upon arrival at the BASE facility at 23:00 for the assessment visits anthropometric (height, weight and body composition) measurements and blood pressure are recorded. The researchers will also check verbally that the control meals/snacks were consumed.

An intravenous canula will then be inserted by an experienced nurse or phlebotomist 45 minutes before the start of the trial. One baseline blood sample will be taken at baseline ( time 0 minutes), followed by provision of a healthy meal (low glycaemic index meal) at 00:00 hrs (midnight) which participants will be asked to consume within 15 minutes. The test meal is a homemade vegetarian pasta dish (2.7 MJ, with 47% energy from carbohydrate (8% total sugars), 40% energy from fat (7% saturates) and 11% energy from protein). Blood sampling will be collected at 15,30,45,60,90.120,180.240,300, and 360 minutes for glucose, triglycerides and insulin.

At hourly intervals, participants are asked about their subjective appetite by completing VAS scales on hunger and fullness, are asked to select from a picture of a vending machine what food they most feel like at that particular time point and to complete a Karolinska sleep scale (KSS) which is a measure of situational sleepiness. Blood samples for RNA extraction are being collected at 0, 120 and 240 minutes.

The washout period between overnight assessment 1 and assessment 2 is a minimum of 7 days.

Intervention code [1] 293645 0
Lifestyle
Comparator / control treatment
The control and intervention overnight assessments are identical, However the 'healthy' meal is replaced with an isocaloric higher in saturated fat and total sugars.

The control meal is a frozen spinach and ricotta pastry with a 200ml can of sprite. This consists of 2.8 mJ of energy, 45% energy from simple carbohydrates, 46% from fat and 7.5% of energy from protein.
Control group
Active

Outcomes
Primary outcome [1] 297079 0
Glucose (incremental area under the curve) will be assessed from blood samples (venous blood) after the two meals
Timepoint [1] 297079 0
Three hour glucose iAUC will be calculated from venous blood samples at eight time points (0, 15,30,45,60,90,120, 180) after the low GI and high GI meal. Calculation of the iAUC takes into account all time points.
Primary outcome [2] 297081 0
Triglycerides (TAGS) (incremental area under the curve) is assessed from blood samples (venous blood) after the two meals
Timepoint [2] 297081 0
Six hour TAGS iAUC (minutes)will be calculated from venous blood samples at seven time points (0, 60, 120, 180, 240, 300, and 360 minutes ) after the two meals. Calculation of the iAUC takes into account all time points.
Secondary outcome [1] 319986 0
Insulin (incremental area under the curve) is assessed from blood samples (venous blood) after the two meals
Timepoint [1] 319986 0
Three hour insulin iAUC (minutes) will be calculated from venous blood samples at eight time points (0,15, 30,45,60,90,120,180) after the low GI and high GI meal.
Secondary outcome [2] 348761 0
Changes in gene expression of circadian genes in peripheral blood mononuclear cells determined by real time polymerase chain reaction.
Timepoint [2] 348761 0
Postprandial change in in gene expression after each meal (fasting, 2 and 4 hours)

Eligibility
Key inclusion criteria
Males, aged between 18 and 50 years, sedentary (rated as low/moderate physical activity on the short form International Physical Activity Questionnaire) , overweight (Body Mass Index (BMI) >= 25 kg/m2), with high fasting TAGs > 1..7 mmol/L who currently maintain a regular sleep-wake cycle.
Minimum age
18 Years
Maximum age
50 Years
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Participants who engage in shift work, smoke, currently taking any lipid lowering, anti-hypertensive, anti-depressive or thyroid deficiency medications, fasting glucose > 6 mmol/L, irregular meal patterns or consume excessive alcohol (>4 standard drinks per day).

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
Incremental area under the curve analysis for blood glucose, triglycerides and insulin levels. Paired data will be used to test for differences in iAUC.

Gene expression data will be analysed using fold change from baseline. Two way repeated measures will be used to test for changes within and between meals in gene expression of Per1, Per2, Per3 and clock genes.

Appropriate adjustments will be made for data not normally distributed or small sample size by normalising data or using non-parametric equivalent statistical tests

P< 0,05 will be taken as significant.

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] 23148 0
3168 - Notting Hill

Funding & Sponsors
Funding source category [1] 292703 0
University
Name [1] 292703 0
Monash University
Address [1] 292703 0
Wellington Road Clayton VIC, 3800
Country [1] 292703 0
Australia
Primary sponsor type
Individual
Name
A/Prof Maxine Bonham
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] 291434 0
None
Name [1] 291434 0
None
Address [1] 291434 0
None
Country [1] 291434 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294189 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 294189 0
First Floor, Room 111
Chancellery Building E
24 Sports Walk
Monash Research Office
Clayton Campus
Monash University VIC 3800
Ethics committee country [1] 294189 0
Australia
Date submitted for ethics approval [1] 294189 0
20/01/2015
Approval date [1] 294189 0
26/03/2015
Ethics approval number [1] 294189 0
CF15/337 - 2015000164

Summary
Brief summary
People who work out of synchronisation with their body clock e.g shift workers face higher rates of chronic diseases such as type 2 diabetes and cardiovascular disease. Eating at night time may contribute to this increased risk by forcing the body to break down and process food at a time usually associated with sleeping. Consuming the same meal at night time compared to the morning is associated with glucose intolerance, insulin resistance and changes in the expression of circadian genes. We hypothesise that altering the type of food consumed at night time may help modify these metabolic risks. In this study we aim to investigate the impact of two isocaloric meals differing in macronutrient composition on glucose and lipid homeostasis and expression of circadian genes in men with high fasting lipids kept awake overnight.
Trial website
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 62654 0
A/Prof Maxine Bonham
Address 62654 0
Department of Nutrition, Dietetics and Food
Monash University
264 Ferntree Gully Road
Notting Hill
VIC 3168
Country 62654 0
Australia
Phone 62654 0
+61 (3) 99024261
Fax 62654 0
Email 62654 0
maxine.bonham@monash.edu
Contact person for public queries
Name 62655 0
A/Prof Maxine Bonham
Address 62655 0
Department of Nutrition and Dietetics
Monash University
264 Ferntree gully Road
Notting Hill
VIC 3168
Country 62655 0
Australia
Phone 62655 0
+61 3 99024272
Fax 62655 0
Email 62655 0
maxine.bonham@monash.edu
Contact person for scientific queries
Name 62656 0
A/Prof Maxine Bonham
Address 62656 0
Department of Nutrition, Dietetics and Food
Monash University
264 Ferntree Gully Road
Notting Hill
VIC 3168
Country 62656 0
Australia
Phone 62656 0
+61 (3) 99024272
Fax 62656 0
Email 62656 0
maxine.bonham@monash.edu

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary