Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001331527
Ethics application status
Approved
Date submitted
12/11/2015
Date registered
4/12/2015
Date last updated
10/11/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of intermittent fasting and high intensity interval training on body composition, markers of metabolic and cardiovascular health and micro ribonucleic acid (miRNA) expression in overweight/obese individuals
Scientific title
Overweight and obese individuals undertaking a combination of high intensity interval training and intermittent fasting in comparison to high intensity interval training and intermittent fasting alone to investigate the effects on weight loss, body composition, microRNA expression and metabolic and cardiovascular risk factors
Secondary ID [1] 287763 0
Nil
Universal Trial Number (UTN)
U1111-1176-0765
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 296649 0
Metabolic Syndrome 296650 0
Condition category
Condition code
Diet and Nutrition 296876 296876 0 0
Obesity
Metabolic and Endocrine 297184 297184 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will undergo one of three, 16 week interventions including: 1) 5:2 diet intermittent fasting diet, 2) supervised high intensity interval training (HIIT) performed 3 days a week, and 3) a combination of both interventions. The 5:2 intermittent fasting diet will involve participants fasting for two non-consecutive days of the week, consuming a single meal of 500kcal for women or 600kcal for men and then fasting for 24 hours. For the remaining five days of the week participant’s dietary intake is unrestricted. Dietary compliance will be monitored weekly using a food diary to record intake on both fasting and non-fasting days. The HIIT protocol used involves 3-6 cycles of 20s cycling at 150% VO2Max followed by 40s of active rest, with 3 minutes of warmup and 3 minutes of warm down with no resistance. The high intensity interval training will be performed in small groups (3-5 participants) supervised by two investigators or personal trainers, and will be performed on bicycle ergometers. Participants will be required to complete at least 42 out of 48 HIIT sessions, with attendance and performance data (Maximum heart rate and heart rate at the completion of each interval) being recorded at each session using data collection forms. Body composition, arterial stiffness, blood pressure, aerobic capacity (VO2Max) and quality of life (mood state questionnaire) will be measured at 0, 8 and 16 weeks. Additionally, blood samples will be taken and measured for lipid profiles, fasting plasma glucose, insulin resistance, markers of inflammation and expression levels of microRNA. Participants will also be asked to continue the interventions for a further period of 8 months self-directed, with follow up measurements performed at the 24, 36 and 52 weeks.
Intervention code [1] 293161 0
Lifestyle
Intervention code [2] 293300 0
Treatment: Other
Comparator / control treatment
This study will use an Intermittent fasting only group and a high intensity interval training only group as the control/comparator groups
Control group
Active

Outcomes
Primary outcome [1] 296479 0
Changes to body weight. This outcome will be measured/monitored through the use of body weight scales.
Timepoint [1] 296479 0
Baseline and 8 & 16 weeks following commencement of the intervention. This outcome will also be assessed at weeks 24, 36 & 52.
Primary outcome [2] 296666 0
Changes to body composition. This outcome will be measured/monitored through the use of body weight scales and dual energy X-ray absorptiometry. This research study involves exposure to a very small amount of radiation. As part of everyday living, everyone is exposed to naturally occurring background radiation and receives a dose of about 2 millisievert (mSv) each year. The effective dose from this study is less than 0.03 mSv. At this dose level, no harmful effects of radiation have been demonstrated as any effect is too small to measure. The risk is believed to be minimal.
Timepoint [2] 296666 0
Baseline, 8 and 16 weeks following commencement of the intervention. This outcome will also be assessed at 52 weeks..
Secondary outcome [1] 318554 0
Effects of interventions on mood state and quality of life. Measured by 100mm VAS questionnaire designed specifically for this study based on the profile of mood states criteria. Composite Outcome...
Timepoint [1] 318554 0
Measured weekly (Baseline - 16 weeks) during the first phase of the trial and monthly in the second phase.
Secondary outcome [2] 318555 0
Changes to Inflammatory markers (IL-6, IL1b, TNF-a). Measurement will be by serum ELISA performed in duplicate.
Timepoint [2] 318555 0
Baseline, 8 & 16 weeks. This outcome will also be assessed at weeks 24, 36 & 52.
Secondary outcome [3] 318556 0
Changes to cardiovascular risk factors. Resting heart rate and peripheral blood pressure will be measured using an automated blood pressure cuff, arterial stiffness and central blood will be estimated using SphygmoCor analysis. Composite Outcome..
Timepoint [3] 318556 0
Baseline, 8 & 16 weeks. This outcome will also be assessed at weeks 24, 36 & 52.
Secondary outcome [4] 318557 0
Changes to glucose sensitivity. Measured by oral glucose tolerance using the Matsuda insulin sensitivity index.
Timepoint [4] 318557 0
Baseline, 8 & 16 weeks. This outcome will also be assessed at weeks 24, 36 & 52.
Secondary outcome [5] 319074 0
Changes to standard clinical blood markers (Fasting glucose, cholesterol, triglycerides, liver function, HDL/LDL, EUC, HBA1c). This outcome will be measured using biochemical analysis at Dorevitch Pathology.
Timepoint [5] 319074 0
Baseline, 8 & 16 weeks. This outcome will also be assessed at weeks 24, 36 & 52.
Secondary outcome [6] 319075 0
Aerobic Capacity testing (VO2). This outcome will be measured using a ramped workload protocol using a magnetically braked LODE cycle ergometer until volitional fatigue. Oxygen uptake (VO2) and respiratory exchange ratio (RER) will be measured every 30 seconds. VO2max will be determined if two of the following criteria were met: respiratory exchange ratio RER = 1.15 and/or RPE score = 19 and/or maximum heart rate within ± 10 beats of age predicted maximum (HR max). If the criteria are met, the highest level of VO2 will be defined as VO2 max, however if these criteria are not met the highest VO2 will be termed VO2 peak instead.
Timepoint [6] 319075 0
Baseline, 8 & 16 weeks. This outcome will also be assessed at weeks 24, 36 & 52.
Secondary outcome [7] 319252 0
Expression levels of microRNA. MicroRNA (miRNA) will be extracted from the blood sample using commercial RNA extraction kits. Expression levels of selected serum miRNAs will be measured using RTqPCR. U6 small nuclear RNA will be used as endogenous control for normalization.
Timepoint [7] 319252 0
Baseline, 8 & 16 weeks. This outcome will also be assessed at weeks 24, 36 & 52.

Eligibility
Key inclusion criteria
Overweight or obese but otherwise healthy
Minimum age
18 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy
Receiving treatment for high cholesterol
Type 1 or 2 Diabetes
Hypertensive
Participation in another exercise or dietary study

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)
Allocation was 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
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
BMI and sex matched
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
Repeated measures ANOVA will be used to analyse the data.

Sample size = 260 participants

A power analysis was performed in G*Power
Based on 5% weight loss (Harvie et al., 2011; Idoate et al., 2011)
Effect Size: 0.25
a = 0.05
Correlation= 0.7
Sample Size n=201
Power = 0.95
Assuming 30% drop out n=260

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
2/12/2015
Date of last participant enrolment
Anticipated
16/12/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
260
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 4607 0
Sunshine Hospital - St Albans
Recruitment postcode(s) [1] 12208 0
3021 - Albanvale

Funding & Sponsors
Funding source category [1] 292369 0
University
Name [1] 292369 0
Victoria University
Country [1] 292369 0
Australia
Primary sponsor type
University
Name
Victoria University
Address
Victoria University
PO Box 14428
Australia Melbourne,
Victoria 8001
Country
Australia
Secondary sponsor category [1] 291056 0
None
Name [1] 291056 0
None
Address [1] 291056 0
None
Country [1] 291056 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293842 0
Victoria University Human Research Ethics Committee
Ethics committee address [1] 293842 0
Victoria University
PO Box 14428
Australia Melbourne,
Victoria 8001
Ethics committee country [1] 293842 0
Australia
Date submitted for ethics approval [1] 293842 0
29/07/2015
Approval date [1] 293842 0
19/10/2015
Ethics approval number [1] 293842 0
HRE 15-160

Summary
Brief summary
Intermittent fasting (IF) is any strategy where participants severely restrict caloric intake on one or more days of the week with 'normal' eating on non-fasting days, and has recently gained popularity for weight loss. Intermittent fasting compares well with other traditional nutritional interventions such as long term calorie restriction, with higher levels of dietary adherence reported over time. High intensity interval training (HIIT) has also been reported as an effective and time efficient exercise strategy for weight loss, as well as improvements to markers of cardiovascular and metabolic disease. Individually IF and HIIT are effective, however, their combined effects are unknown. This study intends to examine the short and long term impacts of IF, specifically a 2:5 ratio of fasting days to normal eating days, and HIIT on weight loss and cardio vascular and metabolic health. The influence of these interventions will be monitored separately, or in combination, on body composition, metabolic and cardiovascular health, fitness and quality of life. In addition, the study will identify changes in serum miRNA’s expression. To achieve these aims, overweight and obese individuals will undergo 1 of 3, 16 week interventions including: 1) 5:2 diet intermittent fasting diet, 2) supervised high intensity interval training (HIIT) performed 3 days a week, and 3) a combination of both interventions. Body composition, arterial stiffness, blood pressure, aerobic capacity (VO2 max) and quality of life will be measured at 0, 8 and 16 weeks. Additionally, blood samples will be taken and measured for lipid profiles, fasting plasma glucose, insulin resistance, markers of inflammation and expression levels of microRNA. Participants will also be asked to continue the interventions for a further period of 8 months self-directed, with follow up measurements performed at the 24, 36 and 52 weeks. Effective dietary and exercise interventions that promote long-term adherence and sustained beneficial effects on metabolic and disease markers are required to reduce the increasing rates of obesity.
Trial website
None
Trial related presentations / publications
None to date
Public notes
None

Contacts
Principal investigator
Name 61258 0
Dr Christos Stathis
Address 61258 0
Victoria University
Ballarat Rd, Footscray Park.
Melbourne, Vic, 3011
Country 61258 0
Australia
Phone 61258 0
+61 3 9919 4293
Fax 61258 0
Email 61258 0
christos.stathis@vu.edu.au
Contact person for public queries
Name 61259 0
Mr William Deasy
Address 61259 0
Victoria University
2 McKechnie St,
St Albans, Melbourne, Victoria 3021
Country 61259 0
Australia
Phone 61259 0
+61 3 9919 2076
Fax 61259 0
Email 61259 0
william.deasy@vu.edu.au
Contact person for scientific queries
Name 61260 0
Mr William Deasy
Address 61260 0
Victoria University
2 McKechnie St,
St Albans, Melbourne, Victoria 3021
Country 61260 0
Australia
Phone 61260 0
+61 3 9919 2076
Fax 61260 0
Email 61260 0
william.deasy@vu.edu.au

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
EmbaseEffects of Intermittent Energy Restriction Alone and in Combination with Sprint Interval Training on Body Composition and Cardiometabolic Biomarkers in Individuals with Overweight and Obesity.2022https://dx.doi.org/10.3390/ijerph19137969
N.B. These documents automatically identified may not have been verified by the study sponsor.