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Mediterranean Style Diet and Low Glycemic Responses (MedGICarb)

Primary Purpose

Insulin Sensitivity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hi GI
Sponsored by
Purdue University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Insulin Sensitivity

Eligibility Criteria

30 Years - 69 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Purdue University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

<55 (Low-GI group)

>70 (Hi-GI group).

Arm 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.

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,

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).

Full Information

First Posted
January 11, 2018
Last Updated
July 15, 2020
Sponsor
Purdue University
Collaborators
Federico II University, University of Agriculture Science, Uppsala, Sweden
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1. Study Identification

Unique Protocol Identification Number
NCT03410719
Brief Title
Mediterranean Style Diet and Low Glycemic Responses
Acronym
MedGICarb
Official Title
Effectiveness of Pasta and Other Starchy Foods With a Low Glycemic Response to Promote Cardio-metabolic and Emotional Well-being.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
January 4, 2018 (Actual)
Primary Completion Date
March 21, 2020 (Actual)
Study Completion Date
March 21, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Purdue University
Collaborators
Federico II University, University of Agriculture Science, Uppsala, Sweden

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Sensitivity

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
block randomized, parallel, controlled,
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
166 (Actual)

8. Arms, Groups, and Interventions

Arm Title
<55 (Low-GI group)
Arm Type
Experimental
Arm 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.
Arm Title
>70 (Hi-GI group).
Arm Type
Experimental
Arm 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,
Intervention Type
Other
Intervention Name(s)
Hi GI
Other Intervention Name(s)
Low GI
Intervention Description
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).
Primary Outcome Measure Information:
Title
The effects of Low-GI and Hi-GI diets
Description
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).
Time Frame
15weeks
Secondary Outcome Measure Information:
Title
Insulin Sensitivity
Description
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).
Time Frame
15 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gabriele Riccardi (riccardi@unina.it), M.D
Organizational Affiliation
Federico II University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rikard Landberg (rikard.landberg@slu.), Ph.D
Organizational Affiliation
Uppsala University, Uppsala, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Purdue University
City
West Lafayette
State/Province
Indiana
ZIP/Postal Code
47907
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32885091
Citation
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.
Results Reference
derived

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Mediterranean Style Diet and Low Glycemic Responses

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