Metabolic syndrome, nutrition Nutritional, Metabolic, Endocrine Metabolic syndrome
Conditions
Interventions
Women will be randomly assigned to either an incorporation of pulse or control meals into their diet, which they will consume for a period of 16 weeks. Women will be seen in the clinical unit for a fo
Sponsors
Pulse Canada (Canada)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women between 30 and 65 years of age 2. Have a minimum of two of the following four metabolic risk factors: 2.1. Waist circumference equal to or higher than 88 cm 2.2. Fasting plasma triglycerides equal to or higher than 1.7 mmol/l 2.3. Fasting plasma HDL-cholesterol lower than 1.3 mmol/l 2.4. Fasting blood glucose equal or higher to 5.5 mmol/l
Exclusion criteria
Exclusion criteria: 1. Personal history of Cardiovascular Disease (CVD) or type two diabetes 2. Uncontrolled hypertension (greater than 140/90 mmHg) 3. Familial hypercholesterolaemia 4. Use of medication that interferes with lipid or glucose metabolism 5. Extreme nutritional habits such vegetarianism 6. Smokers 7. Drink more than two drinks of alcohol per day 8. Have known food allergies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcomes will be evaluated at screening, randomisation and weeks 8, 16 and 24. 1. Lipid profile and glycaemia 2. Waist circumference | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Plasma levels of apo A-1, apo B and Lp(a) will be measured at randomisation and at week 16 2. LDL particle size will be measured at randomisation and at week 16 3. Plasma haemostatic balance markers: fibrinogen and PAI-1 will be measured at randomisation and at week 16 4. Plasma inflammation mediators: CRP, IL-6 and TNF-a will be measured at randomisation and at week 16 5. Plasma levels of homocysteine will be measured at randomisation and at week 16 6. Insulin sensitivity (Homeostatic Model Assessment version 2 [HOMA2] and Quantitative Insulin Sensitivity Check Index [QUICKI]) will be measured at randomisation and at week 16 7. Blood pressure will be measured at randomisation and each follow-up visit thereafter 8. Anthropometric variables (weight and height) will be measured at randomisation and each follow-up visit thereafter 9. Body composition (fat mass, fat-free mass, percentage of body fat, basal metabolic rate will be assessed by impedance analysis) will be measures at randomisation and each follow-up visit thereafter 10. Dietary habit strength (self-report index of habit strength will be measured at randomisation and at week 24) 11. Eating behaviour (51-item Three-Factor Eating Questionnaire (TFEQ) will be evaluated at baseline and at week 24) 12. Changes in the food consumed by their families (questionnaire related to their food-related activities at home evaluated at week 24) | — |
Countries
Canada
Outcome results
None listed