Mediterranean Style Diet and Low Glycemic Responses

Insulin Sensitivity Clinical Trial

— MedGICarb  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03410719
• Other study ID #: 16100183
• Status: Completed
• Phase: N/A
• Start date: January 4, 2018
• Est. completion date: March 21, 2020

Study information

• Verified date: July 2020
• Source: Purdue University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 study meal.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: March 21, 2020
• Est. primary completion date: March 21, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Insulin Resistance
• Insulin Sensitivity

Intervention

Other:
• Hi 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).

Locations

Country	Name	City	State
United States	Purdue University	West Lafayette	Indiana

Sponsors (3)

Lead Sponsor	Collaborator
Purdue University	Federico II University, University of Agriculture Science, Uppsala, Sweden

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).	15 weeks