Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000635369
Ethics application status
Approved
Date submitted
27/04/2017
Date registered
2/05/2017
Date last updated
14/02/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Changes in Resting Energy Expenditure with Two Different Schedules of Calorie Restriction
Scientific title
A single-centre centre randomized 6-week parallel group study of two different schedules of caloric restriction on resting energy expenditure in New Zealand men with a BMI >30 kg/m2.
Secondary ID [1] 291785 0
None
Universal Trial Number (UTN)
UTN: U1111-1189-4510
Trial acronym
CREEDS
Linked study record
Not Applicable

Health condition
Health condition(s) or problem(s) studied:
Obesity 303016 0
Condition category
Condition code
Diet and Nutrition 302475 302475 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief Name:
Calorie Restriction: Arm 1 Continuous Daily Restriction (CDR)
Arm 2 Intermittent Very Low Calorie Diet (IVLCD) (see comparator group below)

The CDR arm consists of a daily calorie restriction to 78% of estimate daily requirements, this will be observed daily.

The intervention will be administered as a dietary prescription observed for duration of 6 weeks. A dietary prescription tailored to each participants estimated daily energy intake requirements will be given. Macro-nutrient composition will not be specified. The prescription consists of several days of set recipes. This will be based on baseline resting energy expenditure and self reported physical activity using the International Physical Activity Questionnaire (IPAQ). The recipes will be based on the participants pre-intervention food preferences and have been developed by a research dietitian with over 6 years experience. A 30 minute 1:1 counselling sessions with a member a physician on the research team will be provided at visit 1.

Participants will be provided with access to calorie counting resources: http://www.caloriecount.co.nz/. This is based on the AUSNUT database from the Food Standards Authority, Australia/New Zealand. Participants will also be provided a written guide to reading nutrition labels prepared by the Food Standards Authority, Australia/New Zealand.

Attempts to improve adherence will involve providing dietary counselling in relation to calories and the diet types, menus with a pre-specified diet composition and weekly telephone contact during the study.

Weekly telephone calls of approximately 15 minutes duration, will be made by study by the study physicians. These calls will be performed to confirm ongoing adherence to diet, answer any questions in relation to the diet prescriptions, remind participants about upcoming assessments, to complete instruments prior to their next scheduled visits and to determine if the participants have developed any health problems since last contact.

The dietary prescription will be adjusted at 3 weeks following repeat energy expenditure measurements and physical activity assessments.

Food diary logs at 1 week, 3 weeks and 6 weeks will be used to assess adherence to the intervention.

Participants will be asked to avoid implementing any additional weight loss measures, pharmacological or otherwise during the trial period. They will also be asked to maintain their baseline level of physical activity for the entire trial period in so far as possible. They will be asked to limit & record any alcohol intake.
Intervention code [1] 297898 0
Lifestyle
Intervention code [2] 297921 0
Treatment: Other
Comparator / control treatment
The IVLCD arm consists of an intermittent calorie restriction to 25% of estimated daily requirements on two days per week & 100% of estimated daily requirements on the other days of the week. It will be implemented in an identical fashion to the CDR arm except for the degree and schedule of calorie restriction.
Control group
Active

Outcomes
Primary outcome [1] 301892 0
Mean change in resting energy expenditure, assessed by canopy hood indirect calorimetry following a daily caloric restriction versus an intermittent caloric restriction.
Timepoint [1] 301892 0
At 6 weeks post commencement of intervention
Secondary outcome [1] 334210 0
Mean change in resting energy expenditure, assessed by canopy hood indirect calorimetry following a daily caloric restriction versus an intermittent caloric restriction.
Timepoint [1] 334210 0
At 3 weeks post commencement of intervention
Secondary outcome [2] 334211 0
Change in body composition: Lean Mass, Fat Mass, Visceral Adipose Tissue as assessed by Dual-energy X-ray absorptiometry (DEXA).
Timepoint [2] 334211 0
At 3 weeks post commencement of intervention
Secondary outcome [3] 334212 0
Change in body composition: Lean Mass, Fat Mass, Visceral Adipose Tissue as assessed by Dual-energy X-ray absorptiometry (DEXA).
Timepoint [3] 334212 0
At 6 weeks post commencement of intervention
Secondary outcome [4] 334213 0
Changes in venous fasting glucose measured by Glucose Hexokinase Enzymatic Assay (Abbott)
Timepoint [4] 334213 0
At 6 weeks post commencement of intervention
Secondary outcome [5] 334214 0
Changes in venous HbA1C measured by latex agglutination inhibition immunoassay
(Cobas b101 POC, Roche)
Timepoint [5] 334214 0
At 6 weeks post commencement
Secondary outcome [6] 334215 0
Changes in venous HDL by photometric transmission measurement (Cobas b101 POC, Roche)
Timepoint [6] 334215 0
At 6 weeks post commencement of intervention
Secondary outcome [7] 334216 0
Changes in venous LDL by photometric transmission measurement (Cobas b101 POC, Roche)
Timepoint [7] 334216 0
At 6 weeks post commencement of intervention
Secondary outcome [8] 334217 0
Changes in venous total cholesterol by photometric transmission measurement (Cobas b101 POC, Roche)
Timepoint [8] 334217 0
At 6 weeks post commencement of intervention
Secondary outcome [9] 334218 0
Changes in venous triglycerides by photometric transmission measurement (Cobas b101 POC, Roche)
Timepoint [9] 334218 0
At 6 weeks post commencement of intervention
Secondary outcome [10] 334219 0
Changes in venous thyroid stimulating hormone (TSH) (electrochemiluminescence,Cobas e601, Roche)
Timepoint [10] 334219 0
At 6 weeks post commencement of intevention
Secondary outcome [11] 334220 0
Changes in venous free thyroxine (FT4) (electrochemiluminescence, Cobas e601, Roche)
Timepoint [11] 334220 0
At 6 weeks post commencement of intervention
Secondary outcome [12] 334221 0
Changes in venous tri-iodothyronine (T3) by Carbonylmetalloimmunoassay method (CMIA).
Timepoint [12] 334221 0
At 6 weeks post commencement of intervention
Secondary outcome [13] 334223 0
Change in resting energy expenditure measured by indirect calorimetry on fasting and non-fasting days.
Timepoint [13] 334223 0
At 6 weeks post commencement of interventions
Secondary outcome [14] 334231 0
Changes in venous Leptin measured by ELISA
Timepoint [14] 334231 0
At 6 weeks post commencement of intervention
Secondary outcome [15] 334232 0
Changes in serum Ghrelin measured by ELISA
Timepoint [15] 334232 0
6 weeks post commencement of intervention
Secondary outcome [16] 334233 0
Changes in concentration of serum adiponectin measured by ELISA
Timepoint [16] 334233 0
At 6 weeks post commencement of intervention
Secondary outcome [17] 334234 0
Changes in Satiety assessed by 100mm Visual Analogue scale
Timepoint [17] 334234 0
At 6 weeks post commencement of intervention
Secondary outcome [18] 334235 0
Changes in Satiety assessed by 100mm Visual Analogue scale
Timepoint [18] 334235 0
At 3 weeks post commencement of intervention
Secondary outcome [19] 334236 0
Changes in Hunger assessed by 100mm Visual Analogue scale
Timepoint [19] 334236 0
At 6 weeks post commencement of intervention
Secondary outcome [20] 334237 0
Changes in Hunger assessed by 100mm Visual Analogue scale
Timepoint [20] 334237 0
At 3 weeks post commencement of intervention
Secondary outcome [21] 334238 0
Changes in self rated energy levels assessed by 100mm Visual Analogue Scale
Timepoint [21] 334238 0
At 6 weeks post commencement of intervention
Secondary outcome [22] 334239 0
Changes in self rated energy levels assessed by 100mm Visual Analogue Scale
Timepoint [22] 334239 0
At 3 weeks post commencement of intervention
Secondary outcome [23] 334240 0
Change in self reported calorie intake assessed by quantitative 4 day food diary analysis (Foodworx)
Timepoint [23] 334240 0
At 6 weeks post commencement of intervention
Secondary outcome [24] 334241 0
Change in self reported calorie intake assessed by quantitative 4 day food diary analysis (Foodworx)
Timepoint [24] 334241 0
At 3 weeks post commencement of intervention
Secondary outcome [25] 343153 0
Changes in Physical Activity based on International Physical Activity Questionnaire (IPAQ)
Timepoint [25] 343153 0
At 3 weeks following the start of the diet intervention.
Secondary outcome [26] 343154 0
Changes in Physical Activity based on International Physical Activity Questionnaire (IPAQ)
Timepoint [26] 343154 0
At 6 weeks following the start of the diet intervention.
Secondary outcome [27] 343155 0
Weight
Timepoint [27] 343155 0
At 3 weeks following the start of the diet intervention.
Secondary outcome [28] 343156 0
Weight
Timepoint [28] 343156 0
At 6 weeks following start of the dietary intervention
Secondary outcome [29] 343157 0
Change in Waist Circumference
Timepoint [29] 343157 0
At 3 weeks from the start of the dietary intervention
Secondary outcome [30] 343158 0
Change in Waist Circumference
Timepoint [30] 343158 0
At 6 weeks from the start of the dietary intervention

Eligibility
Key inclusion criteria
BMI greater than or equal to 30 kg/m2.
Minimum age
18 Years
Maximum age
65 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Recent significant weight change > 5 kg over the previous 3 months
Current medical illness or medications (e.g. steroids) that may, in the view of the investigators, influence resting metabolic rate.
Current Smoker
Weight > 220kg, the maximum weight limit on the DEXA machine.
History of any eating disorder.
History of T2DM requiring treatment other than metformin or diet (1) OR poorly controlled T2DM with a HbA1C > 8.0%/64mmol/mol OR a fasting plasma glucose > 10 mmol/L(2)*.

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)
Concealed: Opaque Sealed Envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerized Sequence Generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
ANCOVA will be used to estimate difference in energy expenditure between the intermittent caloric restriction and daily caloric restriction groups. Baseline resting energy expenditure and lean mass will be entered as covariates. Our recruitment target is 36 participants. This number is based on an analysis of energy expenditure per unit body weight in a population of fifteen overweight and obese men & women from our target community. The mean resting energy expenditure per kilogram body weight (REE kg-1 day-1) was 17.93 kcal kg-1 day-1 with a standard deviation of 2.165 kcal kg-1 day-, a drop-out rate of 15%, an alpha of 0.05 and a beta of 0.80. It is conservative and based on two measures of REE, a third measure as planned during our study will reduce the required number of participants.

An interim analysis of the primary end-point will be performed after 20 participants have been studied will be performed to establish how many remaining participants will be required.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/05/2017
Actual
9/05/2017
Date of last participant enrolment
Anticipated
20/11/2017
Actual
12/11/2017
Date of last data collection
Anticipated
1/01/2018
Actual
17/12/2017
Sample size
Target
36
Accrual to date
Final
36
Recruitment outside Australia
Country [1] 8848 0
New Zealand
State/province [1] 8848 0
Wellington

Funding & Sponsors
Funding source category [1] 296290 0
Charities/Societies/Foundations
Name [1] 296290 0
Maurice & Phyllis Paykall Trust
Country [1] 296290 0
New Zealand
Primary sponsor type
Individual
Name
Assoc Prof Jeremy Krebs
Address
Endocrine Diabetes and Research Centre
Wellington Hospital
Private Bag 7902,
Wellington
Postcode 6242
Country
New Zealand
Secondary sponsor category [1] 295211 0
Individual
Name [1] 295211 0
Dr Brian Corley
Address [1] 295211 0
Endocrine Diabetes and Research Centre
Wellington Hospital
Private Bag 7902,
Wellington
Postcode 6242
Country [1] 295211 0
New Zealand
Secondary sponsor category [2] 295218 0
Individual
Name [2] 295218 0
Dr Rosemary Hall
Address [2] 295218 0
Endocrine Diabetes and Research Centre
Wellington Hospital
Private Bag 7902,
Wellington
Postcode 6242
Country [2] 295218 0
New Zealand
Secondary sponsor category [3] 295219 0
Individual
Name [3] 295219 0
Dr Patricia Whitfield
Address [3] 295219 0
Endocrine Diabetes and Research Centre
Wellington Hospital
Private Bag 7902,
Wellington
Postcode 6242
Country [3] 295219 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297521 0
Northern A Health and Disability Ethics Committee
Ethics committee address [1] 297521 0
Health and Disability Ethics Committees
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 297521 0
New Zealand
Date submitted for ethics approval [1] 297521 0
16/11/2016
Approval date [1] 297521 0
20/02/2017
Ethics approval number [1] 297521 0
Ethics ref: 16/NTA/208

Summary
Brief summary
In 2015/2016, 31.6% of all New Zealanders over the age of 15 years were obese. This rising trend in obesity has been observed globally with obesity now affecting more of the world’s population than malnutrition. The World Health Organisation (WHO) estimated a prevalence of T2DM in NZ of 8.5% in 2014. Worldwide the global burden of T2DM is 422 million. Obesity is a disease of energy consumption that exceeds requirements. An individual’s daily calorie requirements are composed mainly of their resting energy expenditure (REE) and physical activity associated energy expenditure.

Measurement of energy expenditure allows precise individualized calorie prescriptions to promote weight loss. However, even when a carefully administered calorie reduction is introduced with controlled physical activity, invariably less weight is lost than predicted. This has been ascribed to adaptive thermogenesis (AT) - changes in REE in response to a dietary intervention that occur in order to maintain weight at its baseline level, but are maladaptive if an individual is attempting to lose weight.
AT is a result of alterations in hypothalamic neuro-hormonal circuitry resulting from obesity. Permanent changes in the regulation of body weight, energy expenditure, appetite, satiety and higher cognitive responses to food occur in the obese individual in response to weight loss. This is mediated by the central melanocortin pathway which interfaces with peripheral organs via the sympathetic and parasympathetic nervous system, leptin, adiponectin, ghrelin, insulin, glucagon and thyroid stimulating hormone, amongst others.
It is not clear whether adaptive thermogenesis in response to calorie restriction requires a period of sustained dietary restriction to develop or will occur with even very brief energy restriction.
An intermittent or interrupted schedule of fasting, compared with a regular schedule of daily restriction, may attenuate the development of adaptive thermogenesis in response to a calorie restricted diet.

Primary Objective: To compare changes in resting energy expenditure in response to 6 weeks of intermittent or continuous calorie restriction.

Secondary Objectives: To compare changes in the following parameters between treatment arms over the 6-week intervention period: fasting glucose, HbA1C & fasting lipids, weight, body composition, TSH, FT4, FT3, leptin, adiponectin, ghrelin, satiety, hunger, dietary adherence, physical activity level & diet composition.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 74310 0
A/Prof Jeremy Krebs
Address 74310 0
Endocrine Diabetes and Research Centre
Wellington Hospital
Private Bag 7902
Postcode 6242
Country 74310 0
New Zealand
Phone 74310 0
+64 4 8062140
Fax 74310 0
Email 74310 0
Jeremy.krebs@ccdhb.org.nz
Contact person for public queries
Name 74311 0
Dr Brian Corley
Address 74311 0
Endocrine Diabetes and Research Centre
Wellington Hospital
Wellington
Private Bag 7902
Postcode 6242
Country 74311 0
New Zealand
Phone 74311 0
+64 4 8062140
Fax 74311 0
Email 74311 0
brian.corley@otago.ac.nz
Contact person for scientific queries
Name 74312 0
Dr Brian Corley
Address 74312 0
Endocrine Diabetes and Research Centre
Wellington Hospital
Wellington
Private Bag 7902
Postcode 6242
Country 74312 0
New Zealand
Phone 74312 0
+ 64 275858589
Fax 74312 0
Email 74312 0
brian.corley@otago.ac.nz

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No Supporting Document Provided



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