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Status:

COMPLETED

Mediterranean Style Diet and Low Glycemic Responses

Lead Sponsor:

Purdue University

Collaborating Sponsors:

Federico II University

University of Agriculture Science, Uppsala, Sweden

Conditions:

Insulin Sensitivity

Eligibility:

All Genders

30-69 years

Phase:

NA

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 ...

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 con...

Eligibility Criteria

Inclusion

  • • 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

  • 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

Key Trial Info

Start Date :

January 4 2018

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 21 2020

Estimated Enrollment :

166 Patients enrolled

Trial Details

Trial ID

NCT03410719

Start Date

January 4 2018

End Date

March 21 2020

Last Update

July 17 2020

Active Locations (1)

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Purdue University

West Lafayette, Indiana, United States, 47907