Mediterranean Style Diet and Low Glycemic Responses

Not Applicable

Completed

• Conditions: Insulin Sensitivity
• Interventions: Other: Hi GI

• Registration Number: NCT03410719
• Lead Sponsor: Purdue University

Brief Summary

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

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.

Study Timeline

• Study Start: 2018-01-04
• Study First Submitted: 2018-01-11
• Study First Submitted QC: 2018-01-18
• Study First Posted: 2018-01-25
• Primary Completion: 2020-03-21
• Study Completion: 2020-03-21
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-15
• Last Update Posted: 2020-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 166

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
>70 (Hi-GI group).	Hi GI	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,
<55 (Low-GI group)	Hi GI	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.

Primary Outcome Measures

Name	Time	Method
The effects of Low-GI and Hi-GI diets	15weeks	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).

Secondary Outcome Measures

Name	Time	Method
Insulin Sensitivity	15 weeks	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).

Trial Locations

Locations (1)

Purdue University; 🇺🇸 West Lafayette, Indiana, United States