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Trial registered on ANZCTR

Registration number

ACTRN12614000396628

Ethics application status

Approved

Date submitted

1/04/2014

Date registered

10/04/2014

Date last updated

4/02/2016

Type of registration

Prospectively registered

Titles & IDs

Public title

Is two days of intermittent fasting per week a feasible weight loss approach in obese male war veterans? A pilot study.

Scientific title

For obese male war veterans aged between 55-75 years, will two days of intermittent fasting per week when compared with a standard 500kcal reduced diet promote more weight loss.

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

U1111-1155-1826

Trial acronym

Linked study record

Health condition

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

Obesity

Condition category

Condition code

Diet and Nutrition

Obesity

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Intermittent Fasting Group
Participants will be asked to follow a diet containing only 500kcal for two non-consecutive days per week and eat normally (unrestricted but encouraged to follow healthy eating guidelines) on the other five days for 6 months. Participants will be taught how to count calories and recieve dietary advice regarding healthy eating and food portions (as per Australian Guide to Healthy Guidelines). A calorie counting book will be provided. They will receive regular dietetic review and monitoring during the first 3 months (baseline, 2 weeks, 4 weeks, 8 weeks and 12 weeks) and minimal contact during the remaining 3 months. The initial session with the dietitian at baseline will be 45 minutes in duration and all subsequent reviews will be 30 minutes in duration. Participants will have biochemical markers (fasting lipids and fasting glucose), biological impedence (to estimate percentage body fat), waist circumference and blood pressure taken at baseline, 3 months and 6 months. They will also complete a food frequency questionnaire and a validated quality of life questionnaire (AQoL 8D scale) at these times. Participants will have weight monitored and will be questioned about their compliance with the diet at all reviews (baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 6 months). In order to promote compliance, participants will be provided with sample recipes and will be able to contact the study dietitian during business hours for further clarification or dietary advice.

Intervention code [1]

Treatment: Other

Intervention code [2]

Lifestyle

Comparator / control treatment

Standard Treatment (Standard Calorie Restricted Group)
Participants will be asked to follow a diet approximately 500kcal less than energy requirements every day for 6 months. Participants will recieve dietary advice regarding healthy eating and food portions (as per Australian Guide to Healthy Guidelines) to achieve this. They will receive regular dietetic review and monitoring during the first 3 months (baseline, 2 weeks, 4 weeks, 8 weeks and 12 weeks) and minimal contact during the remaining 3 months. Participants will have biochemical markers (fasting lipids and fasting glucose), biological impedence (to estimate percentage body fat), waist circumference and blood pressure taken at baseline, 3 months and 6 months. They will also complete a food frequency questionnaire and a validated quality of life questionnaire (AQoL 8D scale) at these times. Participants will have weight monitored and will be questioned about their compliance with the diet at all reviews (baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 6 months). In order to promote compliance, participants will be provided with sample recipes and will be able to contact the study dietitian during business hours for further clarification or dietary advice.

Control group

Active

Outcomes

Primary outcome [1]

Percentage weight loss. Weight will be measured on the same scales and scales will be calibrated prior to the trial commencing.

Timepoint [1]

Baseline and at 2 weeks, 4 weeks, 8 weeks, 12 weeks and 6 months after intervention commencement

Secondary outcome [1]

Total cholesterol (fasting) as assessed by testing collected blood

Timepoint [1]