1. Questionnaires |
a. Sociodemographics: age, ethnicity, sex. |
b. Detailed initial medical history; abbreviated interval history focused on eligibility criteria, CVD, smoking status and diabetes mellitus. Inter-current processes: diseases, level of care they have received, start and end of the process. |
c. Concomitant medications: |
d. Quality of life and food assessment through SF questionnaire 36 validated in Spain by Alonso [24] |
e. Dietary survey, 3 day record, (quantitative and qualitative) at the beginning and end of the study [25]. |
f. Questionnaire drafted specifically for this study, described in table 4. |
2. Physical examination measures |
a. Anthropometric measurements: standing height in centimetres (cm), weight in kg, waist circumference |
b. BP and pulse |
3. Laboratory measures |
a. Fasting serum glucose |
b. Fasting lipid panel (Total Cholesterol, HDL-Cholesterol, LDL- Cholesterol) |