High Pasta vs. Low Pasta Diet in the Treatment of Obesity

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of High Pasta vs. Low Pasta Mediterranean Diet on Weight Loss in the Treatment of Obese Patients

Conditions
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Diet Therapy

Intervention / Treatment
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* Behavioral: High Pasta
* Behavioral: Low Pasta


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Pasta<br>Habitual pasta consumption equal or higher than 5 times/week. | Behavioral: High Pasta<br>* 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.<br>|
| Experimental: Low Pasta<br>Habitual pasta consumption equal or lower than 3 times/week. | Behavioral: Low Pasta<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Body weight at 6 months | Measured in kg according to the standard procedure | baseline, 6 months | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mediterranean Diet, BMI, weight loss, pasta, obesity