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Insulin SensitivityMedGICarbNCT03410719

Mediterranean Style Diet and Low Glycemic Responses

A study testing Hi GI in people with Insulin Sensitivity, run by Purdue University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 30 to 69 yearsHealthy volunteers can take part
Conditions the study is for
Insulin Sensitivity
What is being tested?
Hi GI
Could I receive a placebo?
No, everyone receives an active treatment
How many people
166 participants
Where
1 siteUnited States
Study dates
4 Jan 2018to 21 Mar 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 69 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • • 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.

Who cannot join

  • 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),
Show all 12Show fewer
  • 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 locations and contacts

1 site in 1 country.

United States1 site

  • Purdue University

    West Lafayette, Indiana, 47907

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Hi GI
Medical subject headings
Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hi GIOther

    Also called Low 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).

Study groups in NCT03410719
Study groupRoleWhat they receive
<55 (Low-GI group)Experimentalintervention 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.
Receives: Other: Hi GI
>70 (Hi-GI group).Experimentalintervention 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,
Receives: Other: Hi GI

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 15weeks

Secondary outcomes (1)

  1. 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).

    Measured: 15 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jan 2018
  2. Study start4 Jan 2018
  3. Primary completion21 Mar 2020
  4. Study completion21 Mar 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
block randomized, parallel, controlled,
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
166 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03410719
Sponsor's protocol ID
16100183
Acronym
MedGICarb
Status last verified
Jul 2020
First submitted
11 Jan 2018
Last updated
17 Jul 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 39615596

  • 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.

    PubMed 39004223

  • 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.

    PubMed 38267533

  • 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.

    PubMed 37651979

  • 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.

    PubMed 32885091

Questions about this trial

What is this clinical trial studying?

A study testing Hi GI in people with Insulin Sensitivity, run by Purdue University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The effects of Low-GI and Hi-GI diets (time frame: 15weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03410719, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2020.

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