Mediterranean Style Diet and Low Glycemic Responses

NCT03410719 | Completed

• 1 other identifier: 16100183
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

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.

Conditions

Insulin Sensitivity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Insulin Sensitivity

  15 weeks

Study Arms (2)

<55 (Low-GI group)

EXPERIMENTAL

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

>70 (Hi-GI group).

EXPERIMENTAL

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

Interventions

Hi GI 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).

Also known as: Low GI

<55 (Low-GI group); >70 (Hi-GI group).

Eligibility Criteria

• Age: 30 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Purdue University: lead
• Federico II University: collaborator
• University of Agriculture Science, Uppsala, Sweden: collaborator

Study Sites (1)

Purdue University

West Lafayette, Indiana, 47907, United States

Location

Related Publications (5)

• Giosue A, Skantze V, Hjorth T, Hjort A, Brunius C, Giacco R, Costabile G, Vitale M, Wallman M, Jirstrand M, Bergia R, Campbell WW, Riccardi G, Landberg R. Association of the glucose patterns after a single nonstandardized meal with the habitual diet composition and features of the daily glucose profile in individuals without diabetes. Am J Clin Nutr. 2025 Feb;121(2):246-255. doi: 10.1016/j.ajcnut.2024.11.028. Epub 2024 Nov 28.

  PMID: 39615596 DERIVED

• Hjort A, Bergia RE, Vitale M, Costabile G, Giacco R, Riccardi G, Campbell WW, Landberg R. Low- versus High-Glycemic Index Mediterranean-Style Eating Patterns Improved Some Domains of Health-Related Quality of Life but Not Sleep in Adults at Risk for Type 2 Diabetes: The MEDGICarb Randomized Controlled Trial. J Nutr. 2024 Sep;154(9):2743-2751. doi: 10.1016/j.tjnut.2024.07.005. Epub 2024 Jul 14.

  PMID: 39004223 DERIVED

• Costabile G, Bergia RE, Vitale M, Hjorth T, Campbell W, Landberg R, Riccardi G, Giacco R. Effects on cardiovascular risk factors of a low- vs high-glycemic index Mediterranean diet in high cardiometabolic risk individuals: the MEDGI-Carb study. Eur J Clin Nutr. 2024 May;78(5):384-390. doi: 10.1038/s41430-024-01406-y. Epub 2024 Jan 24.

  PMID: 38267533 DERIVED

• Vitale M, Costabile G, Bergia RE, Hjorth T, Campbell WW, Landberg R, Riccardi G, Giacco R. The effects of Mediterranean diets with low or high glycemic index on plasma glucose and insulin profiles are different in adult men and women: Data from MEDGI-Carb randomized clinical trial. Clin Nutr. 2023 Oct;42(10):2022-2028. doi: 10.1016/j.clnu.2023.08.016. Epub 2023 Aug 25.

  PMID: 37651979 DERIVED

• Bergia RE 3rd, Biskup I, Giacco R, Costabile G, Gray S, Wright A, Vitale M, Campbell WW, Landberg R, Riccardi G. The MEDGICarb-Study: Design of a multi-center randomized controlled trial to determine the differential health-promoting effects of low- and high-glycemic index Mediterranean-style eating patterns. Contemp Clin Trials Commun. 2020 Aug 13;19:100640. doi: 10.1016/j.conctc.2020.100640. eCollection 2020 Sep.

  PMID: 32885091 DERIVED

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Gabriele Riccardi (riccardi@unina.it), M.D

  Federico II University

  PRINCIPAL INVESTIGATOR

• Rikard Landberg (rikard.landberg@slu.), Ph.D

  Uppsala University, Uppsala, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: block randomized, parallel, controlled,

Study Record Dates

• First Submitted: January 11, 2018
• First Posted: January 25, 2018
• Study Start: January 4, 2018
• Primary Completion: March 21, 2020
• Study Completion: March 21, 2020
• Last Updated: July 17, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)