Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000165381
Ethics application status
Approved
Date submitted
23/01/2017
Date registered
31/01/2017
Date last updated
15/10/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Re calibrating the body clock: the impact of restricting the daily feeding window on skeletal muscle health and circadian rhythms in overweight/obese males.
Scientific title
Effects of time-restricted vs unrestricted eating patterns on circadian metabolomics.
Secondary ID [1] 290724 0
Nil
Universal Trial Number (UTN)
U1111-1190-7393
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight and obesity 301299 0
Condition category
Condition code
Diet and Nutrition 301050 301050 0 0
Obesity
Metabolic and Endocrine 301456 301456 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Restricted feeding: daily feeding window limited to 8 h for 5 days.
Participants will receive a participant information letter outlining study procedures and a handbook to log physical activity levels and sleep during the intervention. On trial days, study researchers will use hard copy run sheets to adhere to the study protocol. New staff members will undergo formal training by study coordinators for data collection purposes and receive a standard operating procedure manual.Experimental conditions will take place at the Exercise Science and Nursing facilities within the Daniel Mannix Building at Australian Catholic University.

Visit 1: Total time ~ 1 hour 30 min. This visit on any weekday morning that suits. It will occur between 5-10 days before the start of the intervention period (Visit 2). Anthropometric measurements: Height will be measured using a wall mounted stadiometer. Weight will be measured using digital scales. Hip, waist and neck circumference will be measured with a metal tape measure. All measures will be taken in duplicate.Resting Metabolic Rate (RMR): Participants will be required to lie down in a quiet, dim-lit room for 25 min where RMR will be measured using an automated gas analyser. A hood (clear) will be placed over the participants head and connected to the gas analyser. The 25 minutes includes a 10 minute rest period, followed by a 15 minute period of data collection. DXA: participants will undergo a whole body DXA scan. Participants are required to lay supine on the scanning bed for the duration of the 15 minut scan. There will be one to two scans depending on the body shape of the participant. The machine uses small doses (<1% of the yearly radiation dose) of radiation to estimate tissue density. The total effective dose of radiation has been calculated for this machine and the scans for this study by a Medical Physicist. This test requires the participant be fasted with no food, fluid or exercise/activity prior to the test. Light clothing with no metal items should be worn and all jewellery must be removed. All measures will be taken by trained researchers who hold radiation licences with Victorian Government and comply to the Code of Practice set out by the ARPANSA. Blood pressure: blood pressure (BP) will be measured via an automated blood pressure machine. Three measures will be taken, a minimum of 1 minute apart. Each measure is approximately 3 minutes in duration. The participant will have a cuff applied to the upper portion of the arm. This will inflate and tighten around the arm and then slowly release. Three-day dietary record: At this visit, participants will be given a three day diet record to complete prior to both experimental conditions. Participants will be asked to record all food and fluid consumed over a three-day period prior to both experimental conditions. Prior to the second experimental condition, participants will be asked to replicate, as close as possible, the dietary intake consumed in the lead up to the first experimental condition whilst still recording dietary intake during this time.

Visit 2 and 4 (Day 0): Total time ~ 1 hour 30 min. This will always be on a Saturday morning. Visit 2 will occur 5-10 days following visit 1. Visit 4 will take place after the first intervention arm and the 14 day washout period.

Continuous blood glucose monitoring (CGM): participants will be required to wear the minimally invasive Medtronic iPro2 blood glucose monitoring system for duration of both experimental conditions. The monitor is the size of a 50 cent piece and inserted rather painlessly into the subcutaneous tissue of the lower back. The iPro2 will be worn for the pre-trial days (Day 1-4), and then throughout the 24 h laboratory visit (Day 5-6).

Physical activity and sleep monitors: to assess physical activity and sleep, participants will be fitted with an inclinometer (ActivPAL3TM) worn on the thigh, an ActiGraph accelerometer worn around the waist, and a SenseWear armband worn on the tricep muscle, to be worn continuously throughout both experimental conditions. Participants will be instructed to replicate the same ‘activity’ patterns during their second treatment. Participants will be instructed to maintain their usual sleep pattern and avoid all activities impacting circadian rhythm (e.g. late night television).

Visit 3 and 5 (Day 5-6 of intervention): Total time ~24 h. Occur following Day 1-4 of following the diet intervention. Throughout the 24 h stay in the laboratory, muscle biopsy and BP measurements will take place every 4 hours (12 in total). Blood samples will be taken hourly between 0700 and 2300 (17 in total) and two hourly from 2300 until 0700 (4 in total).

Blood sampling: an in-dwelling venous catheter will be inserted and 252 mL of blood in total will be collected across the two trials. Four-hourly blood samples will be collected. All samples will be centrifuged immediately, the plasma or serum removed and frozen immediately (-80 degrees C) for later analysis.

Muscle biopsy: The first muscle biopsy will be taken at 0700 h regardless of experimental condition and immediately frozen (-80 degrees C) for subsequent analysis. The muscle biopsy will be taken by Dr Andrew Garnham (20 years experience). Muscle biopsy samples will be taken every 4 hours after 0700 h with the last at 0300 h. Six muscle biopsies will be obtained for each experimental condition.

Blood pressure: Measurement procedure as described in Visit One. These will take place every 4 hours as per the same time schedule as the muscle biopsies.

Dietary intervention: During Days 1 to 4, participants will consume provided meals within an 8 h window (1000 h to 1800 h; RESTRICTED condition). During Day 5 participants will attend the laboratory for a 24 h period while continuing to eat provided meals across the same 8 h time window. The diet provided will be a high-fat, low carbohydrate diet containing 50% fat, 30% carbohydrate, 20% protein. Total daily kilojoule intake will be determined from the RMR measurement in Visit One and using a physical activity factor of 1.4. The same diet will be provided for both conditions, yet, the timing of intake will differ. An Accredited Practising Dietitian (Dr Brooke Devlin) will design and implement all diets. Participants will be provided with a comprehensive food checklist for the 5 day intervention period and will be asked to tick off foods once consumed to monitor adherence. Additionally, they will be asked to note down the time the meals are consumed. Verbal confirmation will also take place upon arrival to the 24 h lab stay. There will be a 14 day washout period between trial.

Following both trials, participants will take part in a semi-structured qualitative interview to investigate their perspectives on the timing of meals in each condition and whether or not they believe they could apply the different timing of meals to their daily routine. This will be completed once only (15 minutes).
Intervention code [1] 296624 0
Lifestyle
Intervention code [2] 296957 0
Treatment: Other
Comparator / control treatment
Unrestricted feeding: mimicking the typical daily feeding window of 15 h for 5 days.

All procedures described in the 'Description of interventions' field will be replicated for the unrestricted feeding condition. The only difference in this condition is the duration of the daily feeding window of 15 h each day for 5 days (0700-2200 h).
Control group
Active

Outcomes
Primary outcome [1] 300476 0
Circadian metabolic profiling by metabolomics analysis of serum, plasma and skeletal muscle tissue using mass spectrometry (by Prof Sassone-Corsi’s lab) including: Lipids (fatty acids, lysolipids, phospholipids, sphingolipids, eicosanoids, monoacylglycerols, diacylglycerols, sterols, steroids, bile acid, polyunsaturated Fatty Acid (n3 and n6), endocannabinoid), Amino Acids (creatine/guanidine/acetamido metabolism, histidine metabolism, lysine metabolism, methionine/cysteine/SAM metabolism, phenylalanine/tyrosine metabolism, leucine/isoleucine/valine metabolism, tryptophan metabolism, alanine/aspartate metabolism, urea cycle products, and polyamine metabolism products), Nucleotides (pyrimidine and purine metabolism products), Energy (glycolysis, gluconeogenesis and TCA cycle metabolites), Carbohydrates (pentose metabolism, aminosugar metabolism, fructose/mannose/galactose metabolism, advanced glycation end products) and Cofactors and Vitamins (nicotinate/nicotinamide metabolism, ascorbate/aldarate metabolism, pantothenate/CoA metabolism, vitamin B metabolites, vitamin A, riboflavin).
Timepoint [1] 300476 0
Skeletal muscle biopsy and blood sampling will take place four hourly for 24 h on Day 5-6 of each intervention arm in order to measure metabolomics.
Secondary outcome [1] 330049 0
Blood profiles of glucose and insulin measured using plasma samples either immediately (glucose) or stored at -80 degrees celcius and measured using ELISA assay (insulin).
Timepoint [1] 330049 0
Blood sampling will be taken hourly from 0700-11pm and 2 hourly from 11pm through to 7am the next morning on Day 5 to 6 of each intervention period.
Secondary outcome [2] 330050 0
24 h blood glucose profile measured by continuous glucose monitor.
Timepoint [2] 330050 0
Blood glucose will be sampled every 5 min for 6 days (from Day 1 to Day 6 of each intervention arm).
Secondary outcome [3] 333759 0
Attitudes and opinions obtained from qualitative interview regarding applicability of a restricted dietary pattern.
Timepoint [3] 333759 0
Following the completion of BOTH trials.
Secondary outcome [4] 344595 0
Sedentary and activity patterns assessed via the use of ActivPal/Actigraph activity monitors
Timepoint [4] 344595 0
Measured for each 5 day dietary period (inclusive) for all participants.
Secondary outcome [5] 344596 0
Daily energy expenditure measured via Sensewear armbands
Timepoint [5] 344596 0
During both 5 day dietary interventions
Secondary outcome [6] 352885 0
Blood profiles of triglyclerides measured using plasma samples stored at -80 degrees celcius and measured using ELISA assay.
Timepoint [6] 352885 0
Blood sampling will be taken hourly from 0700-11pm and 2 hourly from 11pm through to 7am the next morning on Day 5 to 6 of each intervention period.
Secondary outcome [7] 352886 0
Blood profile of ghrelin measured using plasma samples stored at -80 degrees celcius and measured using ELISA assay.
Timepoint [7] 352886 0
Blood sampling will be taken hourly from 0700-11pm and 2 hourly from 11pm through to 7am the next morning on Day 5 to 6 of each intervention period.
Secondary outcome [8] 352887 0
Blood profiles of GLP-1 measured using plasma samples either stored at -80 degrees celcius and measured using ELISA assay
Timepoint [8] 352887 0
Blood sampling will be taken hourly from 0700-11pm and 2 hourly from 11pm through to 7am the next morning on Day 5 to 6 of each intervention period.
Secondary outcome [9] 352888 0
Blood profiles o finflammatory markers (TNF alpha and IL-6 )using plasma samples either stored at -80 degrees celcius and measured using ELISA assay
Timepoint [9] 352888 0
Blood sampling will be taken hourly from 0700-11pm and 2 hourly from 11pm through to 7am the next morning on Day 5 to 6 of each intervention period.

Eligibility
Key inclusion criteria
Sedentary (in terms of activity and job, <150 min/week moderate-intensity exercise for > 3 months and sitting > 5 hours each day); BMI 27-35 kg/m2.
Minimum age
30 Years
Maximum age
45 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Major or chronic illness that impairs mobility or eating/digestion; previous bariatric surgery; smokers; individuals with strict dietary intake regimes (i.e. vegan, avoidances of principal study foods); individuals who do not regularly consume a breakfast meal; individuals who do not have a regularly consume 3 meals per day (i.e. breakfast, lunch, dinner), individuals who have not been weight stable for the last 3 months; shift work or transmeridian travel in the last three months; regular sleep-wake cycle (i.e. go to sleep and wake up within a 2 hour window each 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 concealment will take place using sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization sequencing will take place using an online random number generator.
An independent third party will prepare the computer-generated randomization lists and sealed envelopes for randomization. Once informed consent is obtained, the sealed randomization envelope will be opened revealing the trial-condition order.
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 from the two conditions will be analysed using Generalised Linear Mixed Models, with baseline measures of dietary intake, body fatness, etc. as covariates. Statistical significance will be set at p<0.05. All data will be represented as mean +/- SD. Statistical analysis will be undertaken using SPSS (Version 22 for Windows, SPSS Inc, Chicago, IL).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
30/01/2017
Date of last participant enrolment
Anticipated
17/04/2017
Actual
8/05/2017
Date of last data collection
Anticipated
26/06/2017
Actual
23/06/2017
Sample size
Target
10
Accrual to date
Final
11
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 14859 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 295155 0
Charities/Societies/Foundations
Name [1] 295155 0
Novo Nordisk Foundation
Country [1] 295155 0
Denmark
Primary sponsor type
Individual
Name
Professor John Hawley
Address
Level 5, 215 Spring St
Centre for Exercise and Nutrition
Mary MacKillop Institute for Health Research
Melbourne, 3000
VICTORIA
Country
Australia
Secondary sponsor category [1] 293977 0
None
Name [1] 293977 0
Address [1] 293977 0
Country [1] 293977 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296505 0
Australian Catholic University Human Research Ethics Committee
Ethics committee address [1] 296505 0
Ethics committee country [1] 296505 0
Australia
Date submitted for ethics approval [1] 296505 0
15/09/2016
Approval date [1] 296505 0
28/10/2016
Ethics approval number [1] 296505 0
2016-215H

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

Contacts
Principal investigator
Name 71082 0
Prof John Hawley
Address 71082 0
Level 5, 215 Spring St
Centre for Exercise and Nutrition
Mary MacKillop Institute for Health Research
Melbourne, 3000
VICTORIA
Country 71082 0
Australia
Phone 71082 0
+61 3 9953 3552
Fax 71082 0
Email 71082 0
[email protected]
Contact person for public queries
Name 71083 0
Brooke Devlin
Address 71083 0
Level 5, 215 Spring St
Centre for Exercise and Nutrition
Mary MacKillop Institute for Health Research
Melbourne, 3000
VICTORIA
Country 71083 0
Australia
Phone 71083 0
+61 3 92308052
Fax 71083 0
Email 71083 0
[email protected]
Contact person for scientific queries
Name 71084 0
John Hawley
Address 71084 0
Level 5, 215 Spring St
Centre for Exercise and Nutrition
Mary MacKillop Institute for Health Research
Melbourne, 3000
VICTORIA
Country 71084 0
Australia
Phone 71084 0
+61 3 9953 3552
Fax 71084 0
Email 71084 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

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA delayed morning and earlier evening time-restricted feeding protocol for improving glycemic control and dietary adherence in men with overweight/obesity: A randomized controlled trial.2020https://dx.doi.org/10.3390/nu12020505
N.B. These documents automatically identified may not have been verified by the study sponsor.