Insulin Sensitivity Clinical Trial
— MedGICarbOfficial title:
Effectiveness of Pasta and Other Starchy Foods With a Low Glycemic Response to Promote Cardio-metabolic and Emotional Well-being.
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 |
Verified date | July 2020 |
Source | Purdue University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Purdue University | West Lafayette | Indiana |
Lead Sponsor | Collaborator |
---|---|
Purdue University | Federico II University, University of Agriculture Science, Uppsala, Sweden |
United States,
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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