Effect of a dietary portfolio on metabolic syndrome

Completed

Conditions: Metabolic syndrome
Nutritional, Metabolic, Endocrine

Registration Number: ISRCTN96579359

Lead Sponsor: Institution of Science and Technology of Mexico City (Instituto de Ciencia y Tecnología del Distrito Federal) (Mexico)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 97

Inclusion Criteria

1. Mexican mestizos
2. Men and women aged 20 - 60 years
3. Body mass index (BMI in kg/m^2) between 25 and 39.9
4. Recruited from the surrounding community of Mexico City
5. Present three or more signs of metabolic syndrome following:
5.1. Fasting plasma glucose between 100 mg/dl and 126 mg/dl
5.2. Triacylglycerol (TG) level greater than 150 mg/dl
5.3. Low high density lipoprotein (HDL) cholesterol (less than 40 mg/dl for men, less than 50 mg/dl for women)
5.4. Waist circumference greater than 102 cm for men, greater than 88 cm for women
5.5. Systolic blood pressure greater than 130 mmHg and greater than 85 mmHg diastolic

Exclusion Criteria

1. Patients with glucose greater than or equal to 126 mmHg or diagnosed by a doctor with any type of diabetes, diseases that occur secondarily acquired obesity and diabetes
2. History of cardiovascular event
3. Weight loss greater than 3 kg in the last three months
4. Catabolic disease as cancer and acquired immune deficiency virus (AIDS)
5. Pregnancy
6. Smoking history
7. History of substance abuse or alcoholism
8. No subject should have taken any lipid-lowering medication, antihypertensive, hypoglycaemic, steroids, chemotherapy, immunosuppressant, radiation, and anorectics six month prior to treatment
9. Taking regular nutritional supplements
10. Systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 100 mmHg

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Area under the curve (AUC) of the glucose, insulin and tryglicerides after of glucose tolerance test at baseline and at the end of the intervention<br>2. Serum leptin, adiponectin and C reactive protein at baseline and at the end of the intervention<br> <br>Measures at baseline, two weeks, six weeks and ten weeks:<br>1. Anthropometric measurement<br>2. Physical activity<br>3. Resting blood pressure<br>4. Lipid profile: serum total cholesterol (TC), trygliceride (TG), HDL-cholesterol, LDL-cholesterol<br>5. Fasting serum glucose concentration<br>6. Fasting serum insulin concentration <br>7. Food intake

Secondary Outcome Measures

Name	Time	Method
1. Polymorphism of ABCA1 R230C (rs9282541); Pro12Ala (rs1801282) and Gly972Arg (rs1801278) genes<br>2. G/I ratio, HOMA, QUICKI, Matsuda and Gutt indexes