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Trial registered on ANZCTR


Registration number
ACTRN12615000246583
Ethics application status
Approved
Date submitted
27/02/2015
Date registered
18/03/2015
Date last updated
23/02/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Metabolic and dietary composition of ad-libitum Paleolithic vs Australian Guide to Healthy Eating diets.
Scientific title
Cardiovascular and metabolic effects and nutrient composition of ad-libitum Paleolithic vs Australian Guide to Healthy Eating diets in healthy females.
Secondary ID [1] 286207 0
NIL
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease
294361 0
Diabetes 294429 0
Obesity 294430 0
Condition category
Condition code
Diet and Nutrition 294565 294565 0 0
Other diet and nutrition disorders
Diet and Nutrition 294734 294734 0 0
Obesity
Metabolic and Endocrine 294735 294735 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The baseline visit included a 20 minute dietary consultation explaining the dietary intervention with a registered Nutritionist. Those in the Paleolithic group were provided with meal ideas obtained from “The Paleo Diet” book (Cordain, 2011) and advised to consume lean meats, fish, eggs, nuts, fruits and vegetables, and small amounts of olive or coconut oils. Grains, cereals and dairy products, any mixed dishes or processed foods that included these items were not permitted. Dairy products were to be replaced with unsweetened almond milk. Sugarless black coffee and tea were allowed. All vegetables were permitted on the diet, except for corn, white potatoes and legumes. Sweet potatoes were offered as an alternative to white potatoes. To ensure adequate carbohydrate, additional serves of fruit were recommended. Dried fruit was limited to one tablespoon per day. The intervention was 28 days in duration. Participants were advised to consume foods on an ad-libitum basis and eat when hungry. Compliance was assessed with a daily checklist of allowable foods. Additional foods consumed outside those allowable, was recorded and coded with a serving size amount. All checklists were returned and checked for completeness.
Intervention code [1] 291368 0
Prevention
Intervention code [2] 291369 0
Lifestyle
Comparator / control treatment
Subjects randomised to the AGHE group were counselled on how to achieve food variety in line with the five food groups and Australian dietary recommendations by a registered Nutritionist. They were advised to increase intake of vegetables, fruit and whole grain products, reduce fat intake, and consume low fat dairy products. The duration of the intervention was 28 days. Subjects received the AGHE plate poster and fridge magnet (NHMRC, 2013). No serving size amounts were discussed with subjects on either diet. Participants were advised to consume foods on an ad-libitum basis and eat when hungry. Compliance was assessed with a daily checklist of allowable foods. Additional foods consumed outside those allowable, was recorded and coded with a serving size amount. All checklists were returned and checked for completeness.
Control group
Active

Outcomes
Primary outcome [1] 294430 0
Total Plasma Cholesterol
Timepoint [1] 294430 0
Baseline and 28 Days
Primary outcome [2] 294431 0
Body Weight (kg) measured with a SECA 763 digital column scale and stadiometer (SECA Ltd, USA).
Timepoint [2] 294431 0
Baseline and 28 Days
Primary outcome [3] 294432 0
Fat Mass Percentage measured by BIA
Timepoint [3] 294432 0
Baseline and 28 Days
Secondary outcome [1] 313286 0
Lipid levels (Total Cholesterol, LDL Cholesterol, HDL cholesterol and Triglycerides). Fasting venous blood samples were collected by Pathwest WA. The Abbott assay was performed according to standard methods by Pathwest Ltd, Perth WA.
Timepoint [1] 313286 0
Baseline and 28 days
Secondary outcome [2] 313287 0
Palatability. This was assessed using a researcher designed questionnaire administered post intervention.
Timepoint [2] 313287 0
28 days
Secondary outcome [3] 313288 0
Feasibility. This was assessed using a researcher designed questionnaire administered post intervention.
Timepoint [3] 313288 0
Daily over the 28 period. The checklist contained a list of allowable foods, which were to be ticked for each time the food was consumed.
Secondary outcome [4] 313462 0
Markers of Glucose Metabolism (Insulin and glucose). Measured via fasting venous blood samples taken by Pathwest, WA and analysed according to standard methods.
Timepoint [4] 313462 0
Baseline and 28 days
Secondary outcome [5] 313574 0
Macro and micronutrient intake
Timepoint [5] 313574 0
Assessed at baseline and at 28 days via a 3 day weighed food record. Data was analysed for macro and micronutrient composition via the use of FoodWorks Professional. All data was entered by a qualified Nutritionist.

Eligibility
Key inclusion criteria
willingness to change dietary patterns and prepare meals for four weeks; were a non-smoker and were not participating in any other studies.
Minimum age
18 Years
Maximum age
70 Years
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
already following any special diet including a low carbohydrate or Paleolithic diet; unwilling to change dietary patterns for four weeks; taking any prescribed medication for blood pressure, blood glucose or blood cholesterol; presence of any diagnosed gastrointestinal disease; renal or liver disease; cardiovascular disease; diabetes or coeliac disease or allergies to eggs, fish, diary, nuts or wheat.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment done by sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generation by simple randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Dietary intervention with comparator group
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
An a priori power analysis was performed using G*Power, version 3.1.9.2 prior to subject recruitment (Faul, Buchner, Erdfelder, & Lang, 2014). Our calculations, based on an expected reduction of 16% in total plasma cholesterol in healthy subjects, with an a-error = 0.05, 80% power and a large effect size (0.5), provided a sample requirement of 17 subjects in each group.

All dietary intake data was entered into FoodWorks v7.0 (Xyris Software, 2012) for analysis of energy and nutrient intakes. Anthropometric and biochemical data were recorded in a Microsoft Excel spreadsheet. Pre and post intervention data and a data set created for the change variables were transferred to SPSS v22.0.0.0 for analysis (IBM Corporation, 2013). Energy, nutrient and anthropometric data were assessed for normality and independent t-tests were conducted to assess differences between groups at baseline. There was a significant difference between groups at baseline for diastolic blood pressure only. A mixed model analysis of variance was used with baseline diastolic blood pressure as covariate to assess changes post-intervention. For all other data sets, a paired t-test was conducted to compare changes within groups. An independent t-test was used for normally distributed data, and a Mann-Whitney independent samples test was utilised for non-normally distributed data, to test for changes between groups. Univariate analysis of variance was conducted to assess results independent of weight loss, energy and nutrient intake. Significance level for test statistics was set at p<0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 9245 0
6027 - Joondalup

Funding & Sponsors
Funding source category [1] 290776 0
University
Name [1] 290776 0
Edith Cowan University
Address [1] 290776 0
270 Joondalup Drive
Joondalup WA 6027
Country [1] 290776 0
Australia
Primary sponsor type
University
Name
Edith Cowan University, School of Exercise and Health Science
Address
270 Joondalup Drive
Joondalup WA 6027
Country
Australia
Secondary sponsor category [1] 289460 0
None
Name [1] 289460 0
Address [1] 289460 0
Country [1] 289460 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292406 0
Edith Cowan University Ethics Committee
Ethics committee address [1] 292406 0
270 Joondalup Drive
Joondalup WA 6027
Ethics committee country [1] 292406 0
Australia
Date submitted for ethics approval [1] 292406 0
Approval date [1] 292406 0
10/09/2013
Ethics approval number [1] 292406 0
10176

Summary
Brief summary
There is an increased awareness in the medical community about the role of diet to prevent and treat cardiovascular disease, diabetes and obesity.
This study will examine two different eating patterns and assess their effect on risk factors for cardiovascular disease, diabetes and obesity.
The study comprises a 4-week dietary intervention, with data collection occurring at the beginning and again at the end of the 4-week period.
We will be comparing the differences in results between the two dietary patterns. This will help us formulate the best dietary pattern to use for future studies, and also to assist the wider community in the treatment and prevention of cardiovascular disease, diabetes and obesity.
Trial website
Trial related presentations / publications
The data analysis is still underway (previous status now amended) - several publications from the study are currently being prepared.
Public notes

Contacts
Principal investigator
Name 55066 0
Mrs Angela Genoni
Address 55066 0
Edith Cowan University
School of Exercise and Health Science
270 Joondalup Drive
Joondalup WA 6027
Country 55066 0
Australia
Phone 55066 0
+61 402 171 009
Fax 55066 0
Email 55066 0
agenoni@our.ecu.edu.au
Contact person for public queries
Name 55067 0
Mrs Angela Genoni
Address 55067 0
Edith Cowan University
School of Exercise and Health Science
270 Joondalup Drive
Joondalup WA 6027
Country 55067 0
Australia
Phone 55067 0
+61 402 171 009
Fax 55067 0
Email 55067 0
agenoni@our.ecu.edu.au
Contact person for scientific queries
Name 55068 0
Mrs Angela Genoni
Address 55068 0
Edith Cowan University
School of Exercise and Health Science
270 Joondalup Drive
Joondalup WA 6027
Country 55068 0
Australia
Phone 55068 0
+61 402 171 009
Fax 55068 0
Email 55068 0
agenoni@our.ecu.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary