Clinical trial NCT03341650: High Pasta vs. Low Pasta Diet in the Treatment of Obesity
Official title: The Effect of High Pasta vs. Low Pasta Mediterranean Diet on Weight Loss in the Treatment of Obese Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diet Therapy
Keywords: Mediterranean Diet
BMI
weight loss
pasta
obesity
Lead sponsor: University of Parma
Sponsor class: OTHER
First posted: 2017-11-14
Enrollment: 44
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline Body weight at 6 months
timeFrame: baseline, 6 months
Secondary outcomes:
measure: Change from baseline Body weight at 3 months
timeFrame: baseline, 3 months
measure: Change from baseline Body weight at 12 months
timeFrame: baseline, 12 months
measure: BMI
timeFrame: baseline, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 12 months
measure: Waist circumference
timeFrame: baseline, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 12 months
measure: Free Fat Mass
timeFrame: baseline, 3 months, 6 months, 12 months
measure: Fat Mass
timeFrame: baseline, 3 months, 6 months, 12 months
measure: Basal Metabolic Rate
timeFrame: baseline, 3 months, 6 months, 12 months
measure: Glucose
timeFrame: baseline, 6 months, 12 months
measure: Insulin
timeFrame: baseline, 6 months, 12 months
measure: HOMA-IR index
timeFrame: baseline, 6 months, 12 months
measure: Total cholesterol
timeFrame: baseline, 6 months, 12 months
measure: HDL cholesterol
timeFrame: baseline, 6 months, 12 months
measure: LDL cholesterol
timeFrame: baseline, 6 months, 12 months
measure: Triglycerides
timeFrame: baseline, 6 months, 12 months
measure: Uric Acid
timeFrame: baseline, 6 months, 12 months
measure: Energy intake
timeFrame: baseline, 3 months, 6 months, 12 months
measure: Nutrient intakes
timeFrame: baseline, 3 months, 6 months, 12 months
measure: Carbohydrate-based food intakes
timeFrame: baseline, 3 months, 6 months, 12 months
measure: Perceived Quality of Life
timeFrame: baseline, 3 months, 6 months, 12 months
Other outcomes:
Locations:
city: Parma
country: Italy
facility: Department of Food and Drug, University of Parma
Study officials:
affiliation: University of Parma
name: Elisabetta Dall'Aglio, MD
role: STUDY_DIRECTOR
References:
citation: 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.