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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]

Nil

Universal Trial Number (UTN)

U1111-1176-0765

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Obesity

Metabolic Syndrome

Condition category

Condition code

Diet and Nutrition

Obesity

Metabolic and Endocrine

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]

Lifestyle

Intervention code [2]

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]

Changes to body weight. This outcome will be measured/monitored through the use of body weight scales.

Timepoint [1]

Baseline and 8 & 16 weeks following commencement of the intervention. This outcome will also be assessed at weeks 24, 36 & 52.

Primary outcome [2]

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]

Baseline, 8 and 16 weeks following commencement of the intervention. This outcome will also be assessed at 52 weeks..

Secondary outcome [1]

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]

Measured weekly (Baseline - 16 weeks) during the first phase of the trial and monthly in the second phase.

Secondary outcome [2]

Changes to Inflammatory markers (IL-6, IL1b, TNF-a). Measurement will be by serum ELISA performed in duplicate.

Timepoint [2]