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

Diet Therapy Clinical Trial

Official title:

The Effect of High Pasta vs. Low Pasta Mediterranean Diet on Weight Loss in the Treatment of Obese Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03341650
• Other study ID #: SP2
• Status: Completed
• Phase: N/A
• Start date: November 2, 2015
• Est. completion date: December 2017

Study information

• Verified date: November 2017
• Source: University of Parma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Diet Therapy

Intervention

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.
• 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.

Locations

Country	Name	City	State
Italy	Department of Food and Drug, University of Parma	Parma

Sponsors (1)

Lead Sponsor	Collaborator
University of Parma

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline Body weight at 6 months	Measured in kg according to the standard procedure	baseline, 6 months
Secondary	Change from baseline Body weight at 3 months	Measured in kg according to the standard procedure	baseline, 3 months
Secondary	Change from baseline Body weight at 12 months	Measured in kg according to the standard procedure	baseline, 12 months
Secondary	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
Secondary	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
Secondary	Free Fat Mass	Estimated by bioelectrical impedance analysis in kg and in %	baseline, 3 months, 6 months, 12 months
Secondary	Fat Mass	Estimated by bioelectrical impedance analysis in kg and in %	baseline, 3 months, 6 months, 12 months
Secondary	Basal Metabolic Rate	Estimated by bioelectrical impedance analysis in kcal/day	baseline, 3 months, 6 months, 12 months
Secondary	Glucose	mg/dL in fasting condition	baseline, 6 months, 12 months
Secondary	Insulin	microU/mL in fasting condition	baseline, 6 months, 12 months
Secondary	HOMA-IR index	calculated from glucose and insulin in fasting condition	baseline, 6 months, 12 months
Secondary	Total cholesterol	mg/dL in fasting condition	baseline, 6 months, 12 months
Secondary	HDL cholesterol	mg/dL in fasting condition	baseline, 6 months, 12 months
Secondary	LDL cholesterol	mg/dL in fasting condition	baseline, 6 months, 12 months
Secondary	Triglycerides	mg/dL in fasting condition	baseline, 6 months, 12 months
Secondary	Uric Acid	mg/dL in fasting condition	baseline, 6 months, 12 months
Secondary	Energy intake	assessed by a 24-h dietary recall as kcal/day	baseline, 3 months, 6 months, 12 months
Secondary	Nutrient intakes	assessed by a 24-h dietary recall as g/day	baseline, 3 months, 6 months, 12 months
Secondary	Carbohydrate-based food intakes	assessed by a 7-day food diary as times/week	baseline, 3 months, 6 months, 12 months
Secondary	Perceived Quality of Life	assessed by the SF36 questionnaire	baseline, 3 months, 6 months, 12 months