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Trial record 44 of 54 for:    barley

Mediterranean Style Diet and Low Glycemic Responses (MedGICarb)

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ClinicalTrials.gov Identifier: NCT03410719
Recruitment Status : Recruiting
First Posted : January 25, 2018
Last Update Posted : February 12, 2019
Sponsor:
Collaborators:
Federico II University
University of Agriculture Science, Uppsala, Sweden
Information provided by (Responsible Party):
Wayne Campbell, Purdue University

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.

Condition or disease Intervention/treatment Phase
Insulin Sensitivity Other: Hi GI Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: block randomized, parallel, controlled,
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: Effectiveness of Pasta and Other Starchy Foods With a Low Glycemic Response to Promote Cardio-metabolic and Emotional Well-being.
Actual Study Start Date : January 4, 2018
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : September 30, 2019

Arm Intervention/treatment
Experimental: <55 (Low-GI group)
intervention weeks 1-12 the subjects in each group will be counseled to follow their weight maintaining assigned diet using a combination of prescribed menus (breakfast, lunch, and snack eating occasions) and an item specific version of the Pasta Recipe Builder (dinner). The two group-specific diet plans will mostly contain the same foods and beverages typically included in Mediterranean-style diets, except for substitutions of major sources of carbohydrate in their meals:Low-GI - pasta, barley, parboiled rice, legumes.
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).
Other Name: Low GI

Experimental: >70 (Hi-GI group).
intervention weeks 1-12 the subjects in each group will be counseled to follow their weight maintaining assigned diet using a combination of prescribed menus (breakfast, lunch, and snack eating occasions) and an item specific version of the Pasta Recipe Builder (dinner). The two group-specific diet plans will mostly contain the same foods and beverages typically included in Mediterranean-style diets, except for substitutions of major sources of carbohydrate in their meals: Hi-GI - rice, potato,
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).
Other Name: Low GI




Primary Outcome Measures :
  1. The effects of Low-GI and Hi-GI diets [ Time Frame: 15weeks ]
    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).


Secondary Outcome Measures :
  1. Insulin Sensitivity [ Time Frame: 15 weeks ]
    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).



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Ages Eligible for Study:   30 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03410719


Contacts
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Contact: Wayne W Campbell, Ph.D. 765-494-8236 campbellw@purdue.edu
Contact: Janet K Green 765-496-6342 jkgreen@purdue.edu

Locations
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United States, Indiana
Purdue University Recruiting
West Lafayette, Indiana, United States, 47907
Contact: Wayne Campbell    765-494-8236    campbellw@purdue.edu   
Contact: Janet Green    765-496-6342    jkgreen@purdue.edu   
Principal Investigator: Gabriele Riccardi (Federico II University, Naples, Italy), M.D.         
Principal Investigator: Rikard Landberg (University of Agriculture Science, Uppsala, Sweden ), Ph.D         
Sponsors and Collaborators
Purdue University
Federico II University
University of Agriculture Science, Uppsala, Sweden
Investigators
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Principal Investigator: Gabriele Riccardi (riccardi@unina.it), M.D Federico II University
Principal Investigator: Rikard Landberg (rikard.landberg@slu.), Ph.D Uppsala University, Uppsala, Sweden

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Responsible Party: Wayne Campbell, Principal Investigator, Purdue University
ClinicalTrials.gov Identifier: NCT03410719     History of Changes
Other Study ID Numbers: 16100183
First Posted: January 25, 2018    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases