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

NCT03341650 | Completed

• 1 other identifier: SP2
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Mediterranean Diet; BMI; weight loss; pasta; obesity

Outcome Measures

Primary Outcomes (1)

• Change from baseline Body weight at 6 months

  Measured in kg according to the standard procedure

  baseline, 6 months

Secondary Outcomes (19)

• Change from baseline Body weight at 3 months

  baseline, 3 months

• Change from baseline Body weight at 12 months

  baseline, 12 months

• BMI

  baseline, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 12 months

• Waist circumference

  baseline, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 12 months

• Free Fat Mass

  baseline, 3 months, 6 months, 12 months

Study Arms (2)

High Pasta

EXPERIMENTAL

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

Behavioral: High Pasta

Low Pasta

EXPERIMENTAL

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

Behavioral: Low Pasta

Interventions

High Pasta BEHAVIORAL

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.

High Pasta

Low Pasta BEHAVIORAL

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.

Low Pasta

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• BMI between 30-45 kg/m2
• healthy subjects
• regular meal consumption
• no celiac disease
• no menopause woman

You may not qualify if:

• with a BMI \<30 or \>45 kg/m2
• having diabetes, hepatic or kidney diseases
• having an eating disorder
• having celiac disease
• menopause woman

Sponsors & Collaborators

• University of Parma: lead

Study Sites (1)

Department of Food and Drug, University of Parma

Parma, 43125, Italy

Location

Related Publications (1)

• 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.

  PMID: 32402585 DERIVED

MeSH Terms

Conditions

Weight Loss; Obesity

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Elisabetta Dall'Aglio, MD

  University of Parma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 7, 2017
• First Posted: November 14, 2017
• Study Start: November 2, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: May 4, 2018

Record last verified: 2017-11

Locations

IT (1)