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

Not Applicable

Completed

• Conditions: Diet Therapy
• Interventions: Behavioral: Low Pasta; Behavioral: High Pasta

• Registration Number: NCT03341650
• Lead Sponsor: University of Parma

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11-02
• Status Verified: 2017-11
• Study First Submitted: 2017-11-07
• Study First Submitted QC: 2017-11-13
• Study First Posted: 2017-11-14
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Last Update Submitted: 2018-05-03
• Last Update Posted: 2018-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low Pasta	Low Pasta	Habitual pasta consumption equal or lower than 3 times/week.
High Pasta	High Pasta	Habitual pasta consumption equal or higher than 5 times/week.

Primary Outcome Measures

Name	Time	Method
Change from baseline Body weight at 6 months	baseline, 6 months	Measured in kg according to the standard procedure

Secondary Outcome Measures

Name	Time	Method
Waist circumference	baseline, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 12 months	Measured in cm according to the standard procedure
Glucose	baseline, 6 months, 12 months	mg/dL in fasting condition
Change from baseline Body weight at 3 months	baseline, 3 months	Measured in kg according to the standard procedure
Change from baseline Body weight at 12 months	baseline, 12 months	Measured in kg according to the standard procedure
Fat Mass	baseline, 3 months, 6 months, 12 months	Estimated by bioelectrical impedance analysis in kg and in %
Basal Metabolic Rate	baseline, 3 months, 6 months, 12 months	Estimated by bioelectrical impedance analysis in kcal/day
HOMA-IR index	baseline, 6 months, 12 months	calculated from glucose and insulin in fasting condition
HDL cholesterol	baseline, 6 months, 12 months	mg/dL in fasting condition
Energy intake	baseline, 3 months, 6 months, 12 months	assessed by a 24-h dietary recall as kcal/day
Nutrient intakes	baseline, 3 months, 6 months, 12 months	assessed by a 24-h dietary recall as g/day
Carbohydrate-based food intakes	baseline, 3 months, 6 months, 12 months	assessed by a 7-day food diary as times/week
Triglycerides	baseline, 6 months, 12 months	mg/dL in fasting condition
Insulin	baseline, 6 months, 12 months	microU/mL in fasting condition
Total cholesterol	baseline, 6 months, 12 months	mg/dL in fasting condition
Perceived Quality of Life	baseline, 3 months, 6 months, 12 months	assessed by the SF36 questionnaire
BMI	baseline, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 12 months	Calculated as body weight in kilograms divided by the square of the height in meters
Free Fat Mass	baseline, 3 months, 6 months, 12 months	Estimated by bioelectrical impedance analysis in kg and in %
LDL cholesterol	baseline, 6 months, 12 months	mg/dL in fasting condition
Uric Acid	baseline, 6 months, 12 months	mg/dL in fasting condition

Trial Locations

Locations (1)

Department of Food and Drug, University of Parma; 🇮🇹 Parma, Italy