Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001703493
Ethics application status
Approved
Date submitted
5/12/2016
Date registered
12/12/2016
Date last updated
14/12/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Health Impacts and Dietary Composition of the Paleolithic and Australian Guide to Healthy Eating Diets in Australia
Scientific title
Gut, cardiovascular and metabolic health impacts of long term Paleolithic diets vs Australian Guide to Healthy Eating Diets: A cross sectional study
Secondary ID [1] 290687 0
Nil
Universal Trial Number (UTN)
U1111-1190-5847
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bowel Health 301222 0
Cardiovascular health 301223 0
Metabolic health 301224 0
Condition category
Condition code
Diet and Nutrition 300980 300980 0 0
Other diet and nutrition disorders
Oral and Gastrointestinal 300981 300981 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cardiovascular 300982 300982 0 0
Coronary heart disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The study comprises a cross sectional, case-control study comparing the long term
health impacts of the Paleolithic diet with a high carbohydrate, low fat diet in healthy volunteers. The Paleolithic diet is based on fruits, vegetables, meat, eggs and nuts and excludes grains, legumes and dairy foods which form part of the evidence based Australian Guide to Healthy Eating guidelines. Primary outcome measures will include faecal short chain fatty acids (SCFA), secondary bile acids,ammonia and phenol concentrations, serum TMAO, SCFA and BCAA concentrations.
Fifty one self-reported long term followers of the Paleolithic diet (greater than 1 year) will be recruited and age and sex matched with 51 controls (total n=102). Once inclusion criteria are met and consent provided, participants will complete a diet history interview, 3-day weighed food record and provide a 48 hour stool and 24 hour urine collection and blood sample for analysis.
Intervention code [1] 296569 0
Not applicable
Comparator / control treatment
Comparator group comprises Australians of similar age and sex to subjects and who consume their regular diet, which includes >1 serve/day of grains, legumes and dairy products and aligns with guidelines of the Australian Guide to Healthy Eating. Participants must meet selection criteria to be considered part of the control group.
Control group
Active

Outcomes
Primary outcome [1] 300406 0
Stool Biochemistry - Short chain fatty acids (SCFA) are being examined as our primary outcome variable and forms the basis of our power calculations for the study, However, other stool biochemical markers will be considered in the evaluation of change in SCFA output.
Timepoint [1] 300406 0
Stool samples are collected over a 48 hour period, which commences 24 hours post enrollment.
Primary outcome [2] 300407 0
Cardiovascular - serum Trimethylamine-N-oxide (TMAO) is being assessed as our primary outcome variable as a marker of cardiovascular disease risk. However, in the assessment of cardiovascular risk, we will consider the results for lipid levels (LDL, HDL, Triglycerides) as a composite measure.
Serum TMAO is being determined via HPLC-MS analysis at Edith Cowan University, serum lipid levels are being determined by standard analytical assay in NATA accredited laboratory (PathWest, Western Australia)
Timepoint [2] 300407 0
Fasting blood sample is collected at a pathology centre 4 days post-enrollment.
Primary outcome [3] 300469 0
Metabolic - Assessment of Branched Chain Amino Acids (BCAA) is a novel biomarker for development of future insulin resistance. We will be examining serum BCAA and considering results for glycated heamoglobin in our analysis of these results.
BCAA analysis will be conducted at ECU Joondalup using HPLC-MS analysis. Glycated Hb will be determined by Pathwest using standardised techniques in a NATA accredited laboratory.
Timepoint [3] 300469 0
Fasting blood sample is collected at pathology centre 4 days post enrollment.
Secondary outcome [1] 329895 0
Stool microbiota analysis - this is an exploratory outcome. Stool samples provided in the 48 hour collection and combined and homogenised prior to DNA sequencing occurring.
Timepoint [1] 329895 0
Collected over 48 hours commencing 2 days post enrollment.
Secondary outcome [2] 330034 0
Serum SCFA is a novel biomarker for bacterial fermentation in the gut. We will be determining serum SCFA using GC-MS at Edith Cowan University and results will be compared to the stool SCFA output as well as the microbiota profile.
Timepoint [2] 330034 0
Fasting blood samples is collected on day 4 - Post enrolment at pathology centre.

A portion of the blood samples provided to Pathwest will be returned to ECU for analysis of serum SCFA.
Secondary outcome [3] 330035 0
Anthropometric - (Fat Mass%)
Timepoint [3] 330035 0
Fat Mass is examined at the initial patient interview using a BodPod chamber.
Secondary outcome [4] 330036 0
Dietary Intake - Dietary intake variables (Fat,Carbohydrate,Protein and Fibre) will be examined and related to differences in our other outcome variables. Nutrient intake differences between groups will also be compared.
Timepoint [4] 330036 0
Participants will complete a 3-day weighed food record, in the three days post enrollment to the study.
Secondary outcome [5] 330044 0
Lipid Levels - HDL,LDL, TG
Timepoint [5] 330044 0
Blood sample is taken 4 days post enrolment, and comprises a fasting blood sample to be taken at PathWest.
Secondary outcome [6] 330045 0
Stool Biochemistry - Ammonia, Phenols, Cresols, Secondary Bile Acids, Fecal Fat, Moisture and Nitrogen - to be used in our analysis of gut health.
Timepoint [6] 330045 0
Stool samples are collected over a 48 hour period, commencing 24 hours post enrollment.

Eligibility
Key inclusion criteria
The study will recruit men and women who meet the following inclusion criteria;
- Men and women aged 18-70 years;
- Have been following the Paleolithic diet or high carbohydrate diet for greater than 1year;
- Willing to complete a 3-day WDR;
- Willing to provide blood, urine and stool sample;
- Non-smoker;
- Not participating in any other studies;
- Have BMI <30 kg/m2
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Subjects will be excluded if they:
- Have taken antibiotics in the last six months;
- Have any digestive disorder which may affect nutrient absorption and gastrointestinal
motility such as Coeliac disease, Irritable Bowel Disease/Disorder, ulcerative colitis or
Crohn’s Disease;
- Have had any surgery involving the gastro-intestinal tract;
- Have diabetes or diagnosed metabolic syndrome;
- Are taking any antihypertensives or lipid lowering medication;
- Have or have had any cardiovascular events or diagnosed cardiovascular disease.
Subjects following a Paleolithic diet that consume >1 serve equivalent per day of grains/legumes will also be excluded from participating.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Case control
Timing
Prospective
Statistical methods / analysis
Biochemical, anthropometric and metabolomics data will be analysed as continuous variables using general linear modelling, with macronutrient intake as fixed factors. Significance level for the test statistics will be set at P<0.05. Data obtained from experiment three will be analysed using SPSS v22.0 (IBM Corporation, 2013) and PRIMER-7 (Primer-E, 2015). Analysis of data in this manner will provide estimations of risk for changes in outcome variables for changing carbohydrate, fat and protein intake. Microbiota analysis will be conducted using PRIMER, a statistical software package designed specifically for ecological use(Primer-E, 2015) which provides data on the phyla, genus and species of bacteria present in stool samples. Changes in the microbiota will be related to changes in biomarkers and changes in macronutrient intake.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
7/09/2016
Date of last participant enrolment
Anticipated
31/07/2017
Actual
30/06/2017
Date of last data collection
Anticipated
31/10/2017
Actual
7/07/2017
Sample size
Target
102
Accrual to date
Final
91
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 14797 0
6027 - Joondalup

Funding & Sponsors
Funding source category [1] 295113 0
University
Name [1] 295113 0
Edith Cowan University
Country [1] 295113 0
Australia
Primary sponsor type
University
Name
Edith Cowan University
Address
270 Joondalup Drive
Joondalup WA 6027
Country
Australia
Secondary sponsor category [1] 293933 0
None
Name [1] 293933 0
None
Address [1] 293933 0
None
Country [1] 293933 0
Other collaborator category [1] 279339 0
Government body
Name [1] 279339 0
CSIRO Food and Nutrition
Address [1] 279339 0
Kintore Avenue,
Adelaide SA 5000
Country [1] 279339 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296466 0
Edith Cowan University Human Research Ethics Committee
Ethics committee address [1] 296466 0
270 Joondalup Drive
Joondalup WA 6027
Ethics committee country [1] 296466 0
Australia
Date submitted for ethics approval [1] 296466 0
20/09/2015
Approval date [1] 296466 0
15/10/2015
Ethics approval number [1] 296466 0
13402

Summary
Brief summary
The study comprises a cross sectional, case-control study comparing the long term
health impacts of the Paleolithic diet with a high carbohydrate, low fat diet in healthy volunteers. Primary outcome measures will include faecal short chain fatty acids (SCFA), secondary bile acids, ammonia and phenol concentrations, serum TMAO, SCFA and BCAA concentrations. Pre-study power calculations have been conservatively based on between group differences in faecal butyrate, with medium effect size (d=0.5) and 80% power. Fifty one self-reported long term followers of the Paleolithic diet (greater than 1 year) will be recruited and age and sex matched with 51 controls (total n=102). Once inclusion criteria are met and consent provided, participants will complete a diet history interview, 3-day weighed food record and provide a 48 hour stool and 24 hour urine collection and blood sample for analysis. Faecal biochemistry (SCFA, bile acids, ammonia, phenol, total moisture) will be determined using gas chromatography (GC) and high performance liquid chromatography (HPLC) methods. Serum samples will be analysed for SCFA, TMAO and BCAA.
Food group, and dietary fibre intake will be analysed using SPSS v22.0 (IBM Corporation, 2013) with between groups and within groups analysis being performed. Data obtained from experiment three will be analysed using SPSS v22.0 (IBM Corporation, 2013) and PRIMER-7 (Primer-E, 2015). Outcome variables will be compared to macronutrient intake as continuous variables using general linear modelling. Analysis of data in this manner will provide estimations of risk for changes in outcome variables for changing carbohydrate, fat and protein intake.
The study will provide significant information to public health educators in relation to Paleolithic and AGHE dietary patterns. The study will provide a significant contribution to the understanding of how total long term dietary patterns, inclusive and exclusive of grains and legumes contribute to the risks of future development of non-infectious bowel disease, diabetes and cardiovascular disease.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1284 1284 0 0
/AnzctrAttachments/371974-CSIRO Confirmation of Proposal and Ethics approval.pdf (Ethics approval)
Attachments [2] 1286 1286 0 0
/AnzctrAttachments/371974-Gut Health Study Information Letter.pdf (Participant information/consent)
Attachments [3] 1287 1287 0 0
/AnzctrAttachments/371974-Handout 2 April 2016 Informed Consent Document.pdf (Participant information/consent)

Contacts
Principal investigator
Name 70954 0
Mrs Angela Genoni
Address 70954 0
Edith Cowan University
School of Medical and Health Sciences
270 Joondalup Drive
Joondalup WA 6027
Building 21, 501
Country 70954 0
Australia
Phone 70954 0
+61402171009
Fax 70954 0
Email 70954 0
agenoni@our.ecu.edu.au
Contact person for public queries
Name 70955 0
Mrs Angela Genoni
Address 70955 0
Edith Cowan University
School of Medical and Health Sciences
270 Joondalup Drive
Joondalup WA 6027
Building 21, 501
Country 70955 0
Australia
Phone 70955 0
+61402171009
Fax 70955 0
Email 70955 0
agenoni@our.ecu.edu.au
Contact person for scientific queries
Name 70956 0
Mrs Angela Genoni
Address 70956 0
Edith Cowan University
School of Medical and Health Sciences
270 Joondalup Drive
Joondalup WA 6027
Building 21, 501
Country 70956 0
Australia
Phone 70956 0
+61402171009
Fax 70956 0
Email 70956 0
agenoni@our.ecu.edu.au

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No Supporting Document Provided



Results publications and other study-related documents

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