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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Pasta | Experimental | Habitual pasta consumption equal or higher than 5 times/week. |
|
| Low Pasta | Experimental | Habitual pasta consumption equal or lower than 3 times/week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Pasta | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline Body weight at 6 months | Measured in kg according to the standard procedure | baseline, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline Body weight at 3 months | Measured in kg according to the standard procedure | baseline, 3 months |
| Change from baseline Body weight at 12 months | Measured in kg according to the standard procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elisabetta Dall'Aglio, MD | University of Parma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Food and Drug, University of Parma | Parma | 43125 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32402585 | Derived | Rosi A, Tesan M, Cremonini A, Biasini B, Bicchieri L, Cossu M, Brighenti F, Dall'Aglio E, Scazzina F. Body weight of individuals with obesity decreases after a 6-month high pasta or low pasta Mediterranean diet weight-loss intervention. Nutr Metab Cardiovasc Dis. 2020 Jun 9;30(6):984-995. doi: 10.1016/j.numecd.2020.02.013. Epub 2020 Feb 24. |
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| ID | Term |
|---|---|
| D015431 | Weight Loss |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| Low Pasta | Behavioral | 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. |
|
| baseline, 12 months |
| BMI | Calculated as body weight in kilograms divided by the square of the height in meters | baseline, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 12 months |
| Waist circumference | Measured in cm according to the standard procedure | baseline, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 12 months |
| Free Fat Mass | Estimated by bioelectrical impedance analysis in kg and in % | baseline, 3 months, 6 months, 12 months |
| Fat Mass | Estimated by bioelectrical impedance analysis in kg and in % | baseline, 3 months, 6 months, 12 months |
| Basal Metabolic Rate | Estimated by bioelectrical impedance analysis in kcal/day | baseline, 3 months, 6 months, 12 months |
| Glucose | mg/dL in fasting condition | baseline, 6 months, 12 months |
| Insulin | microU/mL in fasting condition | baseline, 6 months, 12 months |
| HOMA-IR index | calculated from glucose and insulin in fasting condition | baseline, 6 months, 12 months |
| Total cholesterol | mg/dL in fasting condition | baseline, 6 months, 12 months |
| HDL cholesterol | mg/dL in fasting condition | baseline, 6 months, 12 months |
| LDL cholesterol | mg/dL in fasting condition | baseline, 6 months, 12 months |
| Triglycerides | mg/dL in fasting condition | baseline, 6 months, 12 months |
| Uric Acid | mg/dL in fasting condition | baseline, 6 months, 12 months |
| Energy intake | assessed by a 24-h dietary recall as kcal/day | baseline, 3 months, 6 months, 12 months |
| Nutrient intakes | assessed by a 24-h dietary recall as g/day | baseline, 3 months, 6 months, 12 months |
| Carbohydrate-based food intakes | assessed by a 7-day food diary as times/week | baseline, 3 months, 6 months, 12 months |
| Perceived Quality of Life | assessed by the SF36 questionnaire | baseline, 3 months, 6 months, 12 months |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |