Effectiveness of MD on MetS Patients

NCT ID: NCT06961682

Last Updated: 2025-05-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2027-03-30

Brief Summary

The metabolic syndrome (MetS), is a complicated condition linked to coronary artery disease.This group includes visceral obesity (abdominal or android type obesity), insulin resistance (IR), hypertension, and dyslipidaemia.The global prevalence of MetS is estimated to be about one-quarter of the world population or over a billion global citizens .A high MetS prevalence of 55% was found in Egyptians, 85.6% among diabetics, and 76.6% among hypertensive patients .People can modify their diet, physical activity, decrease smoking habits to lower their chance of developing MetS. Frequent exercise can lower blood pressure while increasing insulin sensitivity, lipolysis, and energy expenditure. It has the ability to improve blood lipid parameters .Diet is one of the most important tools available to improve MetS. However, the diet for the prevention and treatment of MetS remains unspecified beyond weight control and reduction in total calories. Several evidences show that it should generally be low in saturated fats, trans fats, cholesterol, sodium and simple sugars .The adherence to the Mediterranean Diet(MD) brings up two positive features, firstly the activity levels are increased and secondly the environmental impact becomes self-rewarding. The more the MD is favoured, the more the self-productivity is achieved resulting in a stronger life style adaptation .MD causes reduction of CVD incidence and outcomes decreases BP (systolic and diastolic) , inverses association with mortality,improvements in dyslexia, decreases incidence of T2DM.

Conditions

Obesity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Metabolic syndrome patients attending Assiut university hospital

MetS patients with diabetes, hypertension, dyslipidemia and obesity at least three criteria to diagnose the metabolic syndrome

Group Type: EXPERIMENTAL

MD

Intervention Type: DIETARY_SUPPLEMENT

Red meats and sweets minimal consumption once or twice per month Eggs, cheese, poultry and yoghurt weekly consumption Fish and seafood two to three times per week Olive oil varing amount daily Vegetables and fruits daily consumption Legumes and whole grains (bread, pasta, rice and nuts )daily consumption Measure the effect of Mediterranean diet on patient with MetS to control hypertension, diabetes, obesity and dyslipidemia by measuring blood pressure mmHg regularly, Hba1c before, lipid profile LDL, HDL, TG weight (kg) and height (m) to calculate BMI wt kg/ht\^2 m and waist hip ratio by measuring waist and hip circumference before and after the MD

Interventions

MD

Red meats and sweets minimal consumption once or twice per month Eggs, cheese, poultry and yoghurt weekly consumption Fish and seafood two to three times per week Olive oil varing amount daily Vegetables and fruits daily consumption Legumes and whole grains (bread, pasta, rice and nuts )daily consumption Measure the effect of Mediterranean diet on patient with MetS to control hypertension, diabetes, obesity and dyslipidemia by measuring blood pressure mmHg regularly, Hba1c before, lipid profile LDL, HDL, TG weight (kg) and height (m) to calculate BMI wt kg/ht\^2 m and waist hip ratio by measuring waist and hip circumference before and after the MD

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

All people diagnosed as metabolic syndrome

• (Hypertension(systolic BP≥130 or Diastolic BP ≥85)
• prediabetes fasting plasma glucose(100-125),oral glucose tolerance test(140-199)Hba1c(5.7-6.4)ADA
• Diabetes, fasting>125, oral glucose tolerance test>200, Hba1c≥6.5 ADA .
• Hyperlipidaemia(TG≥150 mg\dl-HDL<40 in male and <50 in female) [12]
• Obesity(waist circumference ≥102cm in male and ≥88cm in female) [12]

Exclusion Criteria

• Type 1 diabetes
• Patients with renal or advanced liver disease(Failure)
• Oral contraceptives, psychiatric, neurologic medications and steroid therapy
• Patients with heart failure and presence of stent
• Endocrine disease (Thyroid disease especially hypothyroidism-Cushing disease)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Amira Gaber Osman

Assistant lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

Fam Med Dep AssiutU

Identifier Type: -

Identifier Source: org_study_id