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

University of Parma44 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Diet Therapy

Interventions

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.

Low PastaBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change from baseline Body weight at 6 months

Measured in kg according to the standard procedure

Time frame: baseline, 6 months

Secondary Outcomes

Change from baseline Body weight at 3 months

Measured in kg according to the standard procedure

Time frame: baseline, 3 months

Change from baseline Body weight at 12 months

Measured in kg according to the standard procedure

Time frame: baseline, 12 months

BMI

Calculated as body weight in kilograms divided by the square of the height in meters

Time frame: 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

Time frame: 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 %

Time frame: baseline, 3 months, 6 months, 12 months

Fat Mass

Estimated by bioelectrical impedance analysis in kg and in %

Time frame: baseline, 3 months, 6 months, 12 months

Basal Metabolic Rate

Estimated by bioelectrical impedance analysis in kcal/day

Time frame: baseline, 3 months, 6 months, 12 months

Glucose

mg/dL in fasting condition