Effect of a dietary portfolio on metabolic syndrome

A clinical trial of the effect of a dietary portfolio (nopal, chia seed, soy protein and oatmeal) on parameters associated with metabolic syndrome

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN96579359

Enrollment

Registered

2011-02-17

Start date

2009-08-01

Completion date

Unknown

Last updated

2015-01-13

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

The patients with metabolic syndrome, once they have met with the selection criteria, will participate in two stages. The first one is to standardise the diet in all patients, so that the members are

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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 2. Serum leptin, adiponectin and C reactive protein at baseline and at the end of the intervention Measures at baseline, two weeks, six weeks and ten weeks: 1. Anthropometric measurement 2. Physical activity 3. Resting blood pressure 4. Lipid profile: serum total cholesterol (TC), trygliceride (TG), HDL-cholesterol, LDL-cholesterol 5. Fasting serum glucose concentration 6. Fasting serum insulin concentration 7. Food intake	—

Measure

Time frame

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 2. Serum leptin, adiponectin and C reactive protein at baseline and at the end of the intervention Measures at baseline, two weeks, six weeks and ten weeks: 1. Anthropometric measurement 2. Physical activity 3. Resting blood pressure 4. Lipid profile: serum total cholesterol (TC), trygliceride (TG), HDL-cholesterol, LDL-cholesterol 5. Fasting serum glucose concentration 6. Fasting serum insulin concentration 7. Food intake

—

Secondary

Measure	Time frame
1. Polymorphism of ABCA1 R230C (rs9282541); Pro12Ala (rs1801282) and Gly972Arg (rs1801278) genes 2. G/I ratio, HOMA, QUICKI, Matsuda and Gutt indexes	—

Countries

Mexico

Outcome results

None listed

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