Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000211763
Ethics application status
Approved
Date submitted
17/12/2021
Date registered
7/02/2022
Date last updated
21/06/2024
Date data sharing statement initially provided
7/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of Dietary Approaches on the Metabolic Syndrome (EDAMS Trial)
Scientific title
Effects of a Lower Carbohydrate Mediterranean Dietary Pattern on the Severity of Metabolic Syndrome
Secondary ID [1] 305205 0
Nil known
Universal Trial Number (UTN)
Trial acronym
EDAMS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metabolic Syndrome 323648 0
Cardiovascular Disease 323649 0
Prediabetes 324727 0
type 2 diabetes 324866 0
Condition category
Condition code
Cardiovascular 321188 321188 0 0
Other cardiovascular diseases
Diet and Nutrition 322178 322178 0 0
Obesity
Metabolic and Endocrine 322305 322305 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The lower carbohydrate Mediterranean intervention will be 12 weeks and follow similar guidelines to the traditional Mediterranean, but with a reduced intake of carbohydrates (~55 vs 35% of energy from CHO i.e., less fruit, breads, cereals whilst retaining whole grains, vegetables).

The 12 week lower carbohydrate intervention will also focus on whole foods including wholegrains, some fruits and vegetables whilst following a lower carbohydrate dietary pattern. Whole fat dairy, red meats and eggs will be included. The macronutrient distribution will closely mirror that of the lower carbohydrate Mediterranean intervention (~35% energy CHO; ~20% energy protein; ~45% energy fat).

Participants will receive individual online weekly diet consults ~45 min from a dietitian/nutritionist for the first month and monthly thereafter, energy requirements will be individualised using the Mifflin equation, and adherence measured using food records. No food will be provided.
Intervention code [1] 321738 0
Lifestyle
Intervention code [2] 321739 0
Behaviour
Comparator / control treatment
The 12 week traditional Mediterranean arm will be based on the dietary patterns described in the PREDIMED study (~50-60% energy carbohydrate (CHO); ~15% energy protein; ~25-35% energy Fat) with a focus on olive oil, nuts, seafood, wholegrains, fruit and vegetables. Recommendations for red meat and whole-fat dairy will be in line with the Australian dietary guidelines, and red wine (optional) in line with the NHMRC Australian alcohol guidelines (2020) of two standard drinks and at least two alcohol free days per week.

Participants will receive individual online weekly diet consults for the first month and monthly thereafter, energy requirements will be individualised.
Control group
Active

Outcomes
Primary outcome [1] 328983 0
Change in the Metabolic Syndrome Severity Z Score. A composite score with sex and ethnicity and measures of fasting plasma glucose, blood pressure, HDL, triglycerides (blood samples), waist circumference (tape measure), weight (scales)
Timepoint [1] 328983 0
pre and post 12 week interventions
Secondary outcome [1] 401016 0
Changes in vascular function (measured by Arterial stiffness - Pulse wave velocity using Sphygmocor Excel), Endothelial function - Flow mediated Dilation (using ultrasound), Blood Pressure - 24H Blood pressure monitor, Oscar2 AMBP)
Timepoint [1] 401016 0
pre and post 12 week interventions
Secondary outcome [2] 401017 0
Change in blood glucose measured from fasting blood sample
Timepoint [2] 401017 0
pre and post 12 week interventions
Secondary outcome [3] 404377 0
inflammatory markers (including C reactive protein, TNFa)
Timepoint [3] 404377 0
fasting blood samples pre and post 12 week interventions
Secondary outcome [4] 404378 0
Change in ApoB measured from fasting blood sample
Timepoint [4] 404378 0
fasting blood pre and post 12 week interventions
Secondary outcome [5] 404379 0
Diet satisfaction measured using the 45-item Dietary Satisfaction Questionnaire
Timepoint [5] 404379 0
pre & post 12 week intervention
Secondary outcome [6] 404381 0
Change in body composition assessed with DEXA scan
Timepoint [6] 404381 0
pre intervention, week 3 and post intervention
Secondary outcome [7] 404382 0
Blood glucose measured by continuous glucose monitoring
Timepoint [7] 404382 0
continuously for first 2 weeks of the 12 week intervention
Secondary outcome [8] 404383 0
Physical activity measured by the International Physical Activity Questionnaire
Timepoint [8] 404383 0
Pre and post 12 week intervention
Secondary outcome [9] 404384 0
Mediterranean Diet adherence measured by the Mediterranean Diet Adherence Screener (MEDAS)
Timepoint [9] 404384 0
At pre and post intervention, week 3 and week 8
Secondary outcome [10] 405243 0
Change in waist circumference measured by measuring tape
Timepoint [10] 405243 0
pre intervention, week 3, post intervention
Secondary outcome [11] 405244 0
Change in blood pressure measured by 24 hour blood pressure monitor
Timepoint [11] 405244 0
Pre and post 12 week intervention
Secondary outcome [12] 405245 0
Change in fasting blood glucose from blood sample
Timepoint [12] 405245 0
Pre and post 12 week intervention
Secondary outcome [13] 405246 0
Change in lipids from fasting blood sample (including HDL-cholesterol, LDL-cholesterol, triglycerides, total cholesterol)
Timepoint [13] 405246 0
Pre and post 12 week intervention
Secondary outcome [14] 405247 0
Change in ApoA1 measured from fasting blood sample
Timepoint [14] 405247 0
Pre and post 12 week intervention
Secondary outcome [15] 405248 0
Change in LDL particle size measured from fasting blood sample
Timepoint [15] 405248 0
Pre and post 12 week intervention
Secondary outcome [16] 405249 0
Change in fatty acids (including omega-3 index) measured from fasted blood sample
Timepoint [16] 405249 0
Pre and post 12 week intervention
Secondary outcome [17] 405256 0
Change in body weight assessed by scales
Timepoint [17] 405256 0
pre intervention, week 3 and post intervention
Secondary outcome [18] 405257 0
Dietary Adherence measured using diet history, weighed food records and checklists
Timepoint [18] 405257 0
Diet history pre and post intervention, weighed food record at week 3 and 8, and weekly checklists
Secondary outcome [19] 405259 0
Change in insulin measured from fasted blood sample
Timepoint [19] 405259 0
Pre and post 12 week intervention

Eligibility
Key inclusion criteria
Aged between 30 and 75 years

And, three or more of the following:
-Waist circumference: greater than or equal to 94 cm in males, greater than or equal to 80 cm in females
-Fasting blood glucose: >5.5 mmol/L, HbA1C: greater than or equal to 6% OR diabetes diagnosis (not on insulin)
-Triglycerides: greater than or equal to 1.7 mmol/L
-HDL cholesterol: <1.0mmol/L in males, <1.3mmol/L in females OR lipid lowering medication
-Blood pressure: greater than or equal to 130mm/Hg systolic or greater than or equal to 85mm/Hg diastolic OR blood pressure lowering medication

Non-smoker (>6 months prior to study start)
Stable medication for previous 3 months
Minimum age
30 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to communicate in English
Any history of cardiovascular disease
Kidney or Liver disease
Type 2 Diabetes controlled with insulin of sulfonylureas
Pregnant and lactating
Following a vegetarian/vegan/ketogenic dietary pattern
Red meat or seafood aversion/allergies

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)
sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
stratified for sex permuted block randomisation using computer software
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
Linear Mixed Models

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
13/05/2022
Actual
6/05/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
222
Accrual to date
122
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 309583 0
Government body
Name [1] 309583 0
New South Wales Health
Country [1] 309583 0
Australia
Primary sponsor type
University
Name
University of Wollongong
Address
Bld 32 Illawarra Health and Medical Research Institute
Northfields Ave, Wollongong, NSW 2522
Country
Australia
Secondary sponsor category [1] 310589 0
None
Name [1] 310589 0
Address [1] 310589 0
Country [1] 310589 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309360 0
The University of Wollongong and Illawarra and Shoalhaven Local Health District Health and Medical HREC
Ethics committee address [1] 309360 0
Ethics committee country [1] 309360 0
Australia
Date submitted for ethics approval [1] 309360 0
21/12/2021
Approval date [1] 309360 0
06/04/2022
Ethics approval number [1] 309360 0
2022/036

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 113894 0
Dr Monique Francois
Address 113894 0
University of Wollongong
Northfields Ave, Wollongong, NSW 2522
Country 113894 0
Australia
Phone 113894 0
+61 2 4221 5136
Fax 113894 0
Email 113894 0
[email protected]
Contact person for public queries
Name 113895 0
Monique Francois
Address 113895 0
University of Wollongong
Northfields Ave, Wollongong, NSW 2522
Country 113895 0
Australia
Phone 113895 0
+61 2 4221 5136
Fax 113895 0
Email 113895 0
[email protected]
Contact person for scientific queries
Name 113896 0
Monique Francois
Address 113896 0
University of Wollongong
Northfields Ave, Wollongong, NSW 2522
Country 113896 0
Australia
Phone 113896 0
+61 2 4221 5136
Fax 113896 0
Email 113896 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.