High Pasta vs. Low Pasta Diet in the Treatment of Obesity
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: High Pasta Habitual pasta consumption equal or higher than 5 times/week. |
Behavioral: High 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.
|
| Experimental: Low Pasta Habitual pasta consumption equal or lower than 3 times/week. |
Behavioral: Low 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.
|
Outcome Measures
Primary Outcome Measures
- Change from baseline Body weight at 6 months [baseline, 6 months]
Measured in kg according to the standard procedure
Secondary Outcome Measures
- Change from baseline Body weight at 3 months [baseline, 3 months]
Measured in kg according to the standard procedure
- 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
- Total cholesterol [baseline, 6 months, 12 months]
mg/dL in fasting condition
- 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
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Food and Drug, University of Parma | Parma | Italy | 43125 |
Sponsors and Collaborators
- University of Parma
Investigators
- Study Director: Elisabetta Dall'Aglio, MD, University of Parma
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SP2