Mediterranean Style Diet and Low Glycemic Responses

Study Overview
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Brief Summary
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the aim of this study is to evaluate whether a Mediterranean diet rich in pasta and other starchy foods with a (Low-GI), as compared with a similar Mediterranean diet containing very little pasta and based on starchy foods with a (Hi-GI) is able to reduce insulin and glucose concentrations during a prolonged test study meal.

Detailed Description
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The overall aim of this study is to evaluate whether a Mediterranean diet rich in pasta and other starchy foods with a low glycemic response (Low-GI), as compared with a similar Mediterranean diet containing very little pasta and based on starchy foods with a high glycemic response (Hi-GI) is able to reduce insulin and glucose concentrations during a prolonged test study meal.

Official Title
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Effectiveness of Pasta and Other Starchy Foods With a Low Glycemic Response to Promote Cardio-metabolic and Emotional Well-being.

Conditions
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Insulin Sensitivity

Intervention / Treatment
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* Other: Hi GI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • BMI 25-37 kg/m2 with a waist circumference > 102 cm (males) or > 88 cm (females) and one additional feature of Metabolic Syndrome according to ATPIII [1], including blood pressure > 130/85 or treatment, fasting plasma glucose >100mg/dL, fasting triglycerides >150 mg/dL, HDL cholesterol < 40 mg/dL (males) or 50 mg/dL (females), weight stable (± 3 kg in previous 3 mo); no acute illness; and non-diabetic. Exclusion Criteria: age <30 and >69years; fasting triglycerides ≥400 mg/dL; fasting cholesterol >240 mg/dL or low-density lipoprotein cholesterol>160 mg/dL fasting glucose >126 mg/dL, systolic blood pressure >160 mmHg, diastolic blood pressure >100 mmHg a BMI >37 kg/m2, weight changes during the previous 3 months (greater than ± 3 kg), stable intensive physical activity regimen during the previous 3 months (>3 h/wk of moderate or high intensity exercise, resistance or aerobic training). cardiovascular events (myocardial infarction or stroke) during the 6 months prior to the study; renal and liver failure (creatinine >1.7 mg/dl and ALT/AST >2 times than normal values, respectively); anaemia (Hb <12 g/dL); diabetes mellitus. If you are pregnant

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: block randomized, parallel, controlled,
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: <55 (Low-GI group)<br>intervention weeks 1-12 the subjects in each group will be counseled to follow their weight maintaining assigned diet using a combination of prescribed menus (breakfast, lunch, and snack eating occasions) and an item specific version of the Pasta Recipe Builder (dinner). The two group-specific diet plans will mostly contain the same foods and beverages typically included in Mediterranean-style diets, except for substitutions of major sources of carbohydrate in their meals:Low-GI - pasta, barley, parboiled rice, legumes. | Other: Hi GI<br>* subjects will consume the same quantities of metabolizable CHOs (270 g/d) with 135 g of CHOs assigned to the GI intervention foods. The 135 g of CHOs will be distributed as 35 g GI breakfast product, 40 g GI lunch product, and 60 g GI dinner product. Assuming an average 2400 kcal/d total energy requirement among subjects, the 270 g/d metabolizable CHO equates to 40% of total energy intake (1080 kcal/d). One-half of daily CHO intake (135 g/d) will be the same between the Hi-GI and Low-GI groups, including CHOs in fruits, vegetables, and other foods that all subjects will consume. The other one-half of daily CHO intake (135 g) will be different between the Low-GI and Hi-GI groups. Specifically, the GI values of these foods will either be <55 (Low-GI group) or >70 (Hi-GI group).<br>* Other names: Low GI;|
| Experimental: >70 (Hi-GI group).<br>intervention weeks 1-12 the subjects in each group will be counseled to follow their weight maintaining assigned diet using a combination of prescribed menus (breakfast, lunch, and snack eating occasions) and an item specific version of the Pasta Recipe Builder (dinner). The two group-specific diet plans will mostly contain the same foods and beverages typically included in Mediterranean-style diets, except for substitutions of major sources of carbohydrate in their meals: Hi-GI - rice, potato, | Other: Hi GI<br>* subjects will consume the same quantities of metabolizable CHOs (270 g/d) with 135 g of CHOs assigned to the GI intervention foods. The 135 g of CHOs will be distributed as 35 g GI breakfast product, 40 g GI lunch product, and 60 g GI dinner product. Assuming an average 2400 kcal/d total energy requirement among subjects, the 270 g/d metabolizable CHO equates to 40% of total energy intake (1080 kcal/d). One-half of daily CHO intake (135 g/d) will be the same between the Hi-GI and Low-GI groups, including CHOs in fruits, vegetables, and other foods that all subjects will consume. The other one-half of daily CHO intake (135 g) will be different between the Low-GI and Hi-GI groups. Specifically, the GI values of these foods will either be <55 (Low-GI group) or >70 (Hi-GI group).<br>* Other names: Low GI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effects of Low-GI and Hi-GI diets | All subjects will consume the same quantities of metabolizable carbohydrate (270 g/d) with 135 g of carbohydrates assigned to the GI intervention foods. The 135 g of carbohydrates will be distributed as 35 g GI breakfast product, 40 g GI lunch product, and 60 g GI dinner product. Fiber is set as 35 g/d for both intervention groups. Assuming an average 2400 kcal/d total energy requirement among subjects, the 270 g/d metabolizable CHO equates to 40% of total energy intake (1080 kcal/d). One-half of daily CHO intake (135 g/d) will be the same between the Hi-GI and Low-GI groups, including CHOs in fruits, vegetables, and other foods that all subjects will consume. The other one-half of daily CHO intake (135 g) will be different between the Low-GI and Hi-GI groups. Specifically, the GI values of these foods will either be <55 (Low-GI group) or >70 (Hi-GI group). | 15weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin Sensitivity | Measures of Insulin Sensitivity will include fasting serum lipid-lipoprotein profile, plasma fasting and postprandial glucose, insulin, CRP, C-peptide, fasting HbA1c, 24-hour interstitial continuous glucose monitoring (Medtronic ipro2 Professional CGM device (Northridge, CA). | 15 weeks |