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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03410719
Other study ID # 16100183
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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