Effects of Dietary Approaches on the Metabolic Syndrome (EDAMS Trial)

Not Applicable

Recruiting

• Conditions: Metabolic Syndrome; Cardiovascular Disease; Prediabetes; type 2 diabetes; Cardiovascular - Other cardiovascular diseases; Diet and Nutrition - Obesity; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12622000211763
• Lead Sponsor: niversity of Wollongong

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-07
• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 222

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

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)[ pre and post 12 week interventions]