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Completed

NCT Number: NCT03341650

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

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.

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Key information

Conditions

Diet Therapy Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Food and Drug, University of Parma

Parma, 43125, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Change from baseline Body weight at 6 months

    Time frame: baseline, 6 months

    Measured in kg according to the standard procedure

Secondary outcomes

  1. Change from baseline Body weight at 3 months

    Time frame: baseline, 3 months

    Measured in kg according to the standard procedure

  2. Change from baseline Body weight at 12 months

    Time frame: baseline, 12 months

    Measured in kg according to the standard procedure

  3. BMI

    Time frame: 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

  4. Waist circumference

    Time frame: baseline, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 12 months

    Measured in cm according to the standard procedure

  5. Free Fat Mass

    Time frame: baseline, 3 months, 6 months, 12 months

    Estimated by bioelectrical impedance analysis in kg and in %

  6. Fat Mass

    Time frame: baseline, 3 months, 6 months, 12 months

    Estimated by bioelectrical impedance analysis in kg and in %

  7. Basal Metabolic Rate

    Time frame: baseline, 3 months, 6 months, 12 months

    Estimated by bioelectrical impedance analysis in kcal/day

  8. Glucose

    Time frame: baseline, 6 months, 12 months

    mg/dL in fasting condition

  9. Insulin

    Time frame: baseline, 6 months, 12 months

    microU/mL in fasting condition

  10. HOMA-IR index

    Time frame: baseline, 6 months, 12 months

    calculated from glucose and insulin in fasting condition

  11. Total cholesterol

    Time frame: baseline, 6 months, 12 months

    mg/dL in fasting condition

  12. HDL cholesterol

    Time frame: baseline, 6 months, 12 months

    mg/dL in fasting condition

  13. LDL cholesterol

    Time frame: baseline, 6 months, 12 months

    mg/dL in fasting condition

  14. Triglycerides

    Time frame: baseline, 6 months, 12 months

    mg/dL in fasting condition

  15. Uric Acid

    Time frame: baseline, 6 months, 12 months

    mg/dL in fasting condition

  16. Energy intake

    Time frame: baseline, 3 months, 6 months, 12 months

    assessed by a 24-h dietary recall as kcal/day

  17. Nutrient intakes

    Time frame: baseline, 3 months, 6 months, 12 months

    assessed by a 24-h dietary recall as g/day

  18. Carbohydrate-based food intakes

    Time frame: baseline, 3 months, 6 months, 12 months

    assessed by a 7-day food diary as times/week

  19. Perceived Quality of Life

    Time frame: baseline, 3 months, 6 months, 12 months

    assessed by the SF36 questionnaire

Sponsors and collaborators

Lead sponsor

University of Parma

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Nov 14, 2017
Registry last updated
May 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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