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

NCT ID: NCT03341650

Last Updated: 2018-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-02

Study Completion Date

2017-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diet Therapy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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High Pasta

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

Group Type EXPERIMENTAL

High Pasta

Intervention Type 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.

Low Pasta

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

Group Type EXPERIMENTAL

Low Pasta

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Parma

OTHER

Sponsor Role lead

Responsible Party

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Francesca Scazzina Ph.D.

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elisabetta Dall'Aglio, MD

Role: STUDY_DIRECTOR

University of Parma

Locations

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Department of Food and Drug, University of Parma

Parma, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type DERIVED
PMID: 32402585 (View on PubMed)

Other Identifiers

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SP2

Identifier Type: -

Identifier Source: org_study_id

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