Mediterranean Style Diet and Low Glycemic Responses

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

166 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-04

Study Completion Date

2020-03-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Trial on the GI of Spaghetti Versus Rice as Mixed Meals

NCT03104712

Dietary Modification

COMPLETED NA

Dietary Control of Type 2 Diabetes: Low-Carbohydrate Mediterranean Diet Versus Low-Fat Diet

NCT00725257

Type 2 Diabetes Mellitus

COMPLETED NA

Glycemic Index of Various Types of Pasta in Healthy Volunteers

NCT04494607

Glycemic Index

UNKNOWN NA

Mediterranean Diet and Postprandial Lipemia

NCT00789295

Postprandial Lipemia Type 2 Diabetes

COMPLETED NA

A Randomized Cross-over Trial of the Postprandial Effects of Three Different Diets in Patients With Type 2 Diabetes

NCT01522157

Type 2 Diabetes Mellitus

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Insulin Sensitivity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

block randomized, parallel, controlled,

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

<55 (Low-GI group)

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.

Group Type EXPERIMENTAL

Hi GI

Intervention Type OTHER

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).

>70 (Hi-GI group).

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,

Group Type EXPERIMENTAL

Hi GI

Intervention Type OTHER

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).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Hi GI

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).

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Low GI

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

30 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes