Mediterranean Style Diet and Low Glycemic Responses (MedGICarb)

Purdue University

Status: Completed

Conditions: Insulin Sensitivity

Treatments: Other: Hi GI

Study type: Interventional

Funder types: Other

Identifiers

NCT03410719

16100183

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 166 patients

Sex: All

Ages: 30 to 69 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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166 participants in 2 patient groups

<55 (Low-GI group)

Experimental group

Description:

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.

Treatment:

Other: Hi GI

>70 (Hi-GI group).

Experimental group

Description:

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,

Treatment:

Other: Hi GI