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

Effects of Mediterranean-style diet on inflammation markers and reversion of metabolic syndrome in cancer patients: role of plasmatic calprotectin

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN30371072
Enrollment
150
Registered
2015-10-19
Start date
2014-06-10
Completion date
Unknown
Last updated
2016-10-17

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

Conditions

Metabolic syndrome Nutritional, Metabolic, Endocrine Metabolic syndrome

Interventions

Cancer patients were randomly assigned to either the intervention or the control diet. All participants in the study did not follow any kind of diet treatment eight months before the study. In additio

Sponsors

National Cancer Institute "G. Pascale" Foundation
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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)

Design outcomes

Primary

MeasureTime frame
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 2. Plasma calprotectin measured using blood analysis at baseline, 2, 4 and 6 months

Secondary

MeasureTime frame
1. C-Reactive Protein measured by blood analysis at baseline 2, 4 and 6 months 2. Homocysteine measured by blood analysis at baseline 2, 4 and 6 months 3. Insulin measured by blood analysis at baseline 2, 4 and 6 months 4. HOMA-IR measured by blood analysis at baseline 2, 4 and 6 months 5. LDL-cholesterol measured by blood analysis at baseline 2, 4 and 6 months

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026