Clinical trial NCT03410719: Mediterranean Style Diet and Low Glycemic Responses
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
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Sensitivity
Lead sponsor: Purdue University
Sponsor class: OTHER
Collaborators: name: Federico II University
name: University of Agriculture Science, Uppsala, Sweden
First posted: 2018-01-25
Enrollment: 166
Sex: ALL
Minimum age (years): 30
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: block randomized, parallel, controlled,
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: The effects of Low-GI and Hi-GI diets
timeFrame: 15weeks
Secondary outcomes:
measure: Insulin Sensitivity
timeFrame: 15 weeks
Other outcomes:
Locations:
city: West Lafayette
country: United States
facility: Purdue University
state: Indiana
Study officials:
affiliation: Federico II University
name: Gabriele Riccardi (riccardi@unina.it), M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Uppsala University, Uppsala, Sweden
name: Rikard Landberg (rikard.landberg@slu.), Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
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.