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

Effects of a Lower Carbohydrate Mediterranean Dietary Pattern on the Severity of Metabolic Syndrome

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622000211763
Acronym
EDAMS
Enrollment
200
Registered
2022-02-07
Start date
2022-05-06
Completion date
2025-10-03
Last updated
2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Metabolic Syndrome is a cluster of metabolic and cardiovascular risk factors that affects a large proportion of Australia’s adult population. Fortunately, risk factors such as overweight/obesity, glucose intolerance, higher blood pressure and lipids can be treated with improved diet and lifestyle change. For example, diets such as reduced carbohydrate or Mediterranean style diets have shown positive results in improving these risk factors. We will be testing the effect of different diets on the risk factors of Metabolic Syndrome. The main aim of this study is to test different popular diets for 12 weeks to see which dietary approach works best for individuals with Metabolic Syndrome. Hypothesis - Lower Carbohydrate Mediterranean Diet will better improve Metabolic Syndrome and Cardiovascular disease risk factors

Interventions

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

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.

Sponsors

University of Wollongong
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
30 Years to 75 Years
Healthy volunteers
No

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

Outcome results

None listed

Source: ANZCTR · Data processed: Jun 21, 2026