NCT03341650

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: University of Parma · Academic / Other
• Sex: All
• Age: 20 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Diet Therapy

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2015-11-02
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2017-11-14
• Last updated: 2018-05-04

Locations

1 site across 1 country: Italy