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

University of Parma

Status: Completed

Conditions: Diet Therapy

Treatments: Behavioral: Low Pasta; Behavioral: High Pasta

Study type: Interventional

Funder types: Other

Identifiers

NCT03341650

SP2

Details and patient eligibility

About

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.

Enrollment: 44 estimated patients

Sex: All

Ages: 20 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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44 participants in 2 patient groups

High Pasta

Experimental group

Description:

Habitual pasta consumption equal or higher than 5 times/week.

Treatment:

Behavioral: High Pasta

Low Pasta

Experimental group

Description:

Habitual pasta consumption equal or lower than 3 times/week.

Treatment:

Behavioral: Low Pasta