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

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 Overview

• Status: Completed
• Conditions: Diet Therapy
• Intervention / Treatment: Behavioral: High Pasta; Behavioral: Low Pasta

• Study Type: Interventional
• Enrollment (Anticipated): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Parma, Italy, 43125
    • Department of Food and Drug, University of Parma

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High Pasta; Habitual pasta consumption equal or higher than 5 times/week.	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.
Experimental: Low Pasta; Habitual pasta consumption equal or lower than 3 times/week.	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Parma
• Investigators: Study Director: Elisabetta Dall'Aglio, MD, University of Parma

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2015
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: November 7, 2017
• First Submitted That Met QC Criteria: November 13, 2017
• First Posted (Actual): November 14, 2017

Study Record Updates

• Last Update Posted (Actual): May 4, 2018
• Last Update Submitted That Met QC Criteria: May 3, 2018
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: obesity; weight loss; BMI; Mediterranean Diet; pasta
• Other Study ID Numbers: SP2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No