Trial from ANZCTR


Trial ID ACTRN12611001017910
Trial Status: Registered
Date Submitted: 12/09/2011
Date Registered: 22/09/2011
Retrospectively registered

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Public title MATADOR: Minimising Adaptive Thermogenesis And Deactivating Obesity Rebound
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Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format Effect of Intermittent Versus Continuous Energy Restriction on Body Weight, Resting Metabolic Rate and Neuroendocrine Function in Obese Men.
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Secondary ID [1] 263026 0
Nil
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UTN U1111-1124-4910
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Trial acronym MATADOR
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Health condition(s) or problem(s) studied:
Obesity 270752 0
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Condition category: Condition code:
Metabolic and Endocrine Normal metabolism and endocrine development and function
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270932 270932 0 0
Diet and nutrition Obesity
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270942 270942 0 0

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Descriptions of intervention(s) / exposure The study will comprise 3 phases: [1] Baseline energy balance, [2] Energy restriction intervention, and [3] Post-intervention energy balance. As we have previously shown that provision of food maximises dietary compliance in the free-living situation (1,2,4), food will be home-delivered weekly to participants in all phases of this study. The aim of PHASE 1 is to determine the baseline values of various parameters of the famine reaction before energy restriction and weight loss. During the 4 weeks of PHASE 1, weight stability will be achieved as we have previously published (1-4), by determining maintenance energy requirements from dietary history and resting metabolic rate (RMR), and then providing participants with a weight maintenance diet. In PHASE 2, participants will be randomised to continuous or intermittent energy restriction interventions. The continuous intervention consists of 16 weeks on a diet at 67% of maintenance energy requirements. The intermittent intervention consists of 16 weeks of total energy restriction administered as 2 weeks of energy restriction on a diet at 67% of maintenance energy requirements followed by 2 weeks of energy balance on a diet at 100% of maintenance energy requirements, for a total of 30 weeks. The interventions are designed to elicit a 10% body weight loss. To account for weight lost, the energy restriction will be indexed to body weight and RMR after every 4 weeks of energy restriction, thereby keeping theoretical relative energy deficit consistent across the 16-week period. In PHASE 3, participants will be placed on an energy balance diet referenced to their reduced-weight state for 4 weeks to examine the time course of recovery of metabolic and neuroendocrine markers. The macronutrient distribution in both energy restriction and energy balance diets will be maintained within the range of 25–30% of energy as fat, 15-20% as protein, and 50–60% as carbohydrate. As we have previously shown that provision of food maximises dietary compliance in the free-living situation (1,2,4), food will be home-delivered weekly to participants in this study.

1. Weinsier RL, Hunter GR, Desmond RA, Byrne NM, Zuckerman PA, Darnell BE. Free-living activity energy expenditure in women successful and unsuccessful at maintaining a normal body weight. Am J Clin Nutr. 2002; 75(3):499-504.
2. Byrne NM, Hills AP, Wood RE. Does body composition, relative energy deficit or adaptive thermogenesis explain differences between predicted and actual weight loss in obese adults? Obesity Reviews. 2010;11(Suppl.1):35-36.
3. Byrne NM, Weinsier RL, Hunter GR, et al. Influence of distribution of lean body mass on resting metabolic rate after weight loss and weight regain: comparison of responses in white and black women. Am J Clin Nutr. 2003;77(6):1368-73.
4. Wood RE, Byrne NM, Groves AM, Hills AP, King NK. Achieving energy balance in apparently sedentary obese males. Obesity Reviews. 2010;11(Suppl.1):219.
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Intervention Code:
Treatment: Other 269368 0
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Intervention Code:
Lifestyle 269376 0
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Comparator / control treatment Continuous Energy Restriction is the control treatment
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Control group Active
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Primary Outcome: Body weight will be measured using digital weighing scales. Digital weighing scales are to be used to monitor body weight of participants at home in times between laboratory visits. These scales will be calibrated regularly, and weight will also be measured at the standard laboratory sessions. 279596 0
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Timepoint: Daily - 4 weeks energy balance (pre-intervention)
Daily - 16 weeks (continuous) or 30 weeks (intermittent) energy restriction
Daily - 4 weeks energy balance (post-intervention)
279596 0
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Primary Outcome: Resting metabolic rate via indirect calorimetry 279599 0
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Timepoint: Week 1 and 4 - energy balance (pre-intervention)
Week 4, 8, 12 and 16 - energy restriction
Week 2, 4 - energy balance (post-intervention)
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Primary Outcome: Neuroendocrine status: Overnight fasted blood samples will be collected and concentrations of the following analytes in serum or plasma will be determined: free T3, Free T4, reverse T3, TSH, ACTH, cortisol, testosterone, sex hormone binding globulin, IGF-1, and leptin. 279600 0
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Timepoint: Week 1 and 4 - energy balance (pre-intervention)
Week 4, 8, 12 and 16 - energy restriction
Week 1, 2, 4 - energy balance (post-intervention)
279600 0
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Secondary Outcome: Body composition (Fat Mass and Fat-free Mass) will be assessed using the gold-standard 4-compartment model using air displacement plethysmography (via BodPod), deuterium dilution and Dual Energy X-ray Absorptiometry (DXA) at 4 time points: in energy balance immediately prior to (Phase 1), midway and immediately after the weight loss intervention (Phase 2) and after the 4-wk period of energy balance (Phase 3). In addition, BodPod measurements will be taken at week 1 energy balance (pre-intervention), weeks 4 and 12 of energy restriction, and weeks 1 and 2 of energy balance (post-intervention). 294010 0
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Timepoint: Week 1 and 4 - energy balance (pre-intervention)
Week 4, 8, 12 and 16 - energy restriction
Week 1, 2, 4 - energy balance (post-intervention)
294010 0
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Secondary Outcome: Fasting substrate oxidation via indriect calorimetry 294011 0
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Timepoint: Week 1 and 4 - energy balance (pre-intervention)
Week 4, 8, 12 and 16 - energy restriction
Week 2, 4 - energy balance (post-intervention)
294011 0
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Secondary Outcome: Markers of metabolic health (fasting serum glucose, insulin, triglycerides, cholesterol) 294012 0
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Timepoint: Week 1 and 4 - energy balance (pre-intervention)
Week 4, 8, 12 and 16 - energy restriction
Week 1, 2, 4 - energy balance (post-intervention)
294012 0
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Key inclusion criteria Sedentary (< 60 mins physical activity per week)
Class I or II obese (30-40kg.m-2)
Waist circumference >102 cm
Euthyroid, non-diabetic, ambulatory, and weight stable for at least 6 months (+/-2kg)
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Minimum age 25 Years
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Maximum age 53 Years
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Gender Males
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Healthy volunteers? No
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Key exclusion criteria Diabetic or fasting blood glucose > 6.0 mmol/L (from medical screening)
Major surgery that will affect gut function/metabolic rate
Arthritis/musculoskeletal problems that would preclude full participation in all testing/affect activities of daily living
Heart condition
Sleep apnoea
Thyroid condition
Current smoker or gave up smoking within the last 6 months
Any medications known to affect metabolic rate or neuroendocrine function
Non-ambulatory
Currently on a “diet” or actively losing weight
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Study type Interventional
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Purpose of the study Treatment
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Allocation to intervention Randomised controlled trial
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Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures) Participants will be stratified according to BMI (30-34.9, 35-40) and age (25-38.9, 39-53) and then randomly allocated into either the intermittent energy restriction or continuous energy restriction groups.
Allocation is not concealed.
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Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation) Pemuted block randomisation. Where intermittent energy restriction = 1 and continuous energy restriction = 2.
Where BMI (30-34.9) = A, BMI (35-40) = B, Age (25-38.9) = C, Age (39-53) = D. Each participant will therefore fall into one of four cell options: AC, AD, BC or BD. Each cell will have pair allocations of random sequence 1 or 2.
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Masking / blinding Open (masking not used)
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Who is / are masked / blinded (choose all that apply)


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Assignment Parallel
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Other design features
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Type of endpoint(s) Efficacy
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Statistical Methods/Analysis
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Phase Not Applicable
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Anticipated date of first participant enrolment 6/03/2009
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Date of first participant enrolment
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Anticipated date last participant recruited/enrolled
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Actual date last participant recruited/enrolled
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Target sample size 100
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Actual sample size
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Recruitment status Closed: follow-up continuing
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Recruitment in Australia

Recruitment state(s)
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Recruitment outside Australia

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Funding Source: Government body 269828 0
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Name: National Health and Medical Research Council 269828 0
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Address: Level 1
16 Marcus Clarke Street
Canberra ACT 2601
269828 0
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Country: Australia 269828 0
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Primary Sponsor Individual
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Name: Professor Nuala Byrne
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Address: Institute of Health and Biomedical Innovation
Queensland University of Technology
60 Musk Avenue
Kelvin Grove QLD 4059
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Country: Australia
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Secondary Sponsor: University 268860 0
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Name: Queensland University of Technology 268860 0
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Address: 2 George Street
Brisbane, QLD 4000
268860 0
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Country: Australia 268860 0
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Has the study received approval from at least one Ethics Committee? Yes
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Ethics Committee name: University Human Research Ethics Committee (UHREC) 271796 0
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Address: Governance and Legal Services
Queensland University of Technology
GPO Box 2434
2 George Street
Brisbane Q 4001
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Country: Australia 271796 0
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Approval Date: 08/04/2008 271796 0
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Submitted Date: 271796 0
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HREC: 0800000081 271796 0
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Brief summary There are more than 7 million overweight or obese adults in Australia and on average only about 5% of this population
achieve permanent weight reduction of any significance to their health. Many questions remain regarding the best way to achieve long-term weight loss, and how a person’s metabolic rate is affected both in the short- and long-term during dieting.
The overall aim of this project is to design more effective and sustainable weight loss strategies for overweight and obese adults. This study, funded by the National Health and Medical Research Council (NHMRC), aims to compare changes in weight and health using two different dieting approaches; one in which the energy intake (kilojoule value) changes every two weeks, and the other where the energy intake changes every four weeks. Throughout the intensive phase of the study, participants are provided with a healthy, balanced, energy-regulated diet delivered to their home. Measures of body composition, metabolic rate and energy expenditure, hunger and satiety, blood hormone levels, body fuel usage, and metabolic health will be taken at a number of time points throughout the study.
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Trial website
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Trial related presentations / publications
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Public Notes
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Principal Investigator
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Contact person for public queries
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Name: Professor Nuala Byrne
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Address: Institute of Health and Biomedical Innovation Queensland University of Technology 60 Musk Avenue Kelvin Grove, QLD4059
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Country: Australia
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Tel: 61 7 3138 6088
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Email: n.byrne@qut.edu.au
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Contact person for scientific queries
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Name: Professor Nuala Byrne
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Address: Institute of Health and Biomedical Innovation Queensland University of Technology 60 Musk Avenue Kelvin Grove, QLD4059
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Country: Australia
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Email: n.byrne@qut.edu.au
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Contact person responsible for updating information
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Name: Professor Nuala Byrne
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Address: Institute of Health and Biomedical Innovation Queensland University of Technology 60 Musk Avenue Kelvin Grove, QLD4059
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Country: Australia
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Tel: 61 7 3138 6088
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Email: n.byrne@qut.edu.au
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Addition Cancer fields
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