Diet Therapy
Conditions
Keywords
Mediterranean Diet, BMI, weight loss, pasta, obesity
Brief summary
To the best of our knowledge, the effect of pasta consumption within a hypocaloric Mediterranean diet has only been scarcely explored yet. Therefore, a two-parallel group dietary intervention was carried out to investigate if pasta consumption could affect the BMI change in obese patients. The primary outcome was the loss of at leat 8% of the initial body weight in the first 6 months. Anthropometric and body composition (from bioelectrical impedance analysis - BIA-) measures were collected every month for the first 6 months and after 1 year. In addition, dietary information was collected at baseline and after 3, 6 and 12 months through a 7-day carbohydrate food record and a 24-h food recall. Blood samples were collected at baseline and at 6 and 12 months to assess: glucose, insulin, Homeostatic model assessment for insulin resistant (HOMA-IR) index, total cholesterol, low-density lipoprotein, high-density lipoprotein, and uric acid. Furthermore, the perceived quality of life was investigated through the 36-items short form health survey (SF36) questionnaire.
Interventions
BEHAVIORALHigh Pasta
Participants received a personalised diet program considering their food preferences and eating behaviour, based on the Italian guidelines for a healthy and Mediterranean diet and were encouraged to maintain their habitual consumption of pasta (at least 5 times/week). To encourage participants to prepare healthy meals by using high-quality ingredients, participants were provided with a recipe book and dietary guidelines and recommendations.
BEHAVIORALLow Pasta
Participants received a personalised diet program considering their food preferences and eating behaviour, based on the Italian guidelines for a healthy and Mediterranean diet and were encouraged to maintain their habitual consumption of pasta (no more than 3 times/week). To encourage participants to prepare healthy meals by using high-quality ingredients, participants were provided with a recipe book and dietary guidelines and recommendations.
Sponsors
University of Parma
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* BMI between 30-45 kg/m2 * healthy subjects * regular meal consumption * no celiac disease * no menopause woman
Exclusion criteria
* with a BMI \<30 or \>45 kg/m2 * having diabetes, hepatic or kidney diseases * having an eating disorder * having celiac disease * menopause woman
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline Body weight at 6 months | baseline, 6 months | Measured in kg according to the standard procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline Body weight at 12 months | baseline, 12 months | Measured in kg according to the standard procedure |
| BMI | baseline, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 12 months | Calculated as body weight in kilograms divided by the square of the height in meters |
| Waist circumference | baseline, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 12 months | Measured in cm according to the standard procedure |
| Free Fat Mass | baseline, 3 months, 6 months, 12 months | Estimated by bioelectrical impedance analysis in kg and in % |
| Fat Mass | baseline, 3 months, 6 months, 12 months | Estimated by bioelectrical impedance analysis in kg and in % |
| Basal Metabolic Rate | baseline, 3 months, 6 months, 12 months | Estimated by bioelectrical impedance analysis in kcal/day |
| Glucose | baseline, 6 months, 12 months | mg/dL in fasting condition |
| Insulin | baseline, 6 months, 12 months | microU/mL in fasting condition |
| HOMA-IR index | baseline, 6 months, 12 months | calculated from glucose and insulin in fasting condition |
| Change from baseline Body weight at 3 months | baseline, 3 months | Measured in kg according to the standard procedure |
| HDL cholesterol | baseline, 6 months, 12 months | mg/dL in fasting condition |
| LDL cholesterol | baseline, 6 months, 12 months | mg/dL in fasting condition |
| Triglycerides | baseline, 6 months, 12 months | mg/dL in fasting condition |
| Uric Acid | baseline, 6 months, 12 months | mg/dL in fasting condition |
| Energy intake | baseline, 3 months, 6 months, 12 months | assessed by a 24-h dietary recall as kcal/day |
| Nutrient intakes | baseline, 3 months, 6 months, 12 months | assessed by a 24-h dietary recall as g/day |
| Carbohydrate-based food intakes | baseline, 3 months, 6 months, 12 months | assessed by a 7-day food diary as times/week |
| Perceived Quality of Life | baseline, 3 months, 6 months, 12 months | assessed by the SF36 questionnaire |
| Total cholesterol | baseline, 6 months, 12 months | mg/dL in fasting condition |
Countries
Italy
Outcome results
None listed