The Effect of High Pasta vs. Low Pasta Mediterranean Diet on Weight Loss in the Treatment of Obese Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Change from baseline Body weight at 6 months
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI between 30-45 kg/m2
- •healthy subjects
- •regular meal consumption
- •no celiac disease
- •no menopause woman
排除标准
- •with a BMI <30 or >45 kg/m2
- •having diabetes, hepatic or kidney diseases
- •having an eating disorder
- •having celiac disease
- •menopause woman
研究组 & 干预措施
Low Pasta
Habitual pasta consumption equal or lower than 3 times/week.
干预措施: Low Pasta (Behavioral)
High Pasta
Habitual pasta consumption equal or higher than 5 times/week.
干预措施: High Pasta (Behavioral)
结局指标
主要结局
Change from baseline Body weight at 6 months
时间窗: baseline, 6 months
Measured in kg according to the standard procedure
次要结局
- Triglycerides(baseline, 6 months, 12 months)
- Waist circumference(baseline, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 12 months)
- Glucose(baseline, 6 months, 12 months)
- LDL cholesterol(baseline, 6 months, 12 months)
- Uric Acid(baseline, 6 months, 12 months)
- Change from baseline Body weight at 3 months(baseline, 3 months)
- Change from baseline Body weight at 12 months(baseline, 12 months)
- Fat Mass(baseline, 3 months, 6 months, 12 months)
- Basal Metabolic Rate(baseline, 3 months, 6 months, 12 months)
- HOMA-IR index(baseline, 6 months, 12 months)
- HDL cholesterol(baseline, 6 months, 12 months)
- Energy intake(baseline, 3 months, 6 months, 12 months)
- Nutrient intakes(baseline, 3 months, 6 months, 12 months)
- Carbohydrate-based food intakes(baseline, 3 months, 6 months, 12 months)
- Insulin(baseline, 6 months, 12 months)
- Total cholesterol(baseline, 6 months, 12 months)
- Perceived Quality of Life(baseline, 3 months, 6 months, 12 months)
- BMI(baseline, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 12 months)
- Free Fat Mass(baseline, 3 months, 6 months, 12 months)
研究者
Francesca Scazzina Ph.D.
Assistant Professor
University of Parma