Mediterranean protocol diet rich in whole grains to treat the risk factor Metabolic Syndrome in cancer patients

Completed

Conditions: Metabolic syndrome
Nutritional, Metabolic, Endocrine

Registration Number: ISRCTN30371072

Lead Sponsor: ational Cancer Institute G. Pascale Foundation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 150

Inclusion Criteria

1. Aged between 18 and 65 years
2. Oncology patients
3. Have at least three of the following characteristics:
3.1. Waist circumference of at least 88 cm in women and 102 cm in men
3.2. Low levels of serum high density lipoprotein cholesterol (HDL), specifically less than 40 mg/dL for men and less than 50 mg/dL for women (or taking drug treatment for reduced HDL-C)
3.3. Hypertriglyceridemia with triglycerides level of at least 150 mg/dL (or taking drug treatment for elevated triglycerides is an alternate indicator)
3.4. Systolic blood pressure of at least 130 mmHg and diastolic blood pressure of at least 85 mmHg (or taking antihypertensive drug treatment in a patient with a history of hypertension)
3.5. Fasting plasma glucose value of 100 mg/dL or greater due to loss of glucose homeostasis (or taking drug treatment of elevated glucose is an alternate indicator)

Exclusion Criteria

1. Patients with cognitive and psychosocial problems
2. Genetic disorders
3. Smokers
4. Drug addicts or abusers of alcohol (consumption of at least =500 g/wk in the last year)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Metabolic syndrome markers (waist circumference, blood pressure, HDL-cholesterol, triglycerides, fasting blood glucose) measured using anthropometrics and blood analysis at baseline, 2, 4 and 6 months<br>2. Plasma calprotectin measured using blood analysis at baseline, 2, 4 and 6 months

Secondary Outcome Measures

Name	Time	Method
1. C-Reactive Protein measured by blood analysis at baseline 2, 4 and 6 months<br>2. Homocysteine measured by blood analysis at baseline 2, 4 and 6 months<br>3. Insulin measured by blood analysis at baseline 2, 4 and 6 months<br>4. HOMA-IR measured by blood analysis at baseline 2, 4 and 6 months<br>5. LDL-cholesterol measured by blood analysis at baseline 2, 4 and 6 months