Wholegrain Cereal Diet and Insulin Sensitivity

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ClinicalTrials.gov Identifier: NCT00945854

Recruitment Status : Completed

First Posted : July 24, 2009

Results First Posted : June 26, 2014

Last Update Posted : June 26, 2014

Sponsor:

Information provided by (Responsible Party):

rivellese angela, Federico II University

Study Description

Brief Summary:

A diet with the multiple beneficial characteristics of whole grains and, more in general, of "healthy cereals" favorably influences glucose and insulin metabolism in subjects with metabolic syndrome. Therefore, the aim of the study is to evaluate the long term effects of a diet containing "healthy cereals" versus a control diet, on glucose and insulin metabolism in subjects with metabolic syndrome.

Condition or disease	Intervention/treatment	Phase
Metabolic Syndrome	Other: Wholegrain cereal diet Other: Refined cereal diet	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	60 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Effect of Whole Grain Rich Diet on Insulin Sensitivity in Individuals With Metabolic Syndrome
Study Start Date :	March 2008
Actual Primary Completion Date :	March 2009
Actual Study Completion Date :	December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy Metabolic Syndrome

Drug Information available for: Insulin

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Wholegrain cereal diet Treatment with a diet based on wholegrain cereals and foods with low glycemic index	Other: Wholegrain cereal diet Thirty subjects with metabolic syndrome, after an initial run-in period of 4 weeks, during which they stabilise their own diet and other lifestyle habits, are assigned to a diet based on wholegrain cereals and foods with low glycemic index for a period of 12 weeks. Before and after the dietary treatment, a frequently samples intravenous glucose tolerance is carried out to measure the effects of the intervention on glucose and insulin metabolism. At beginning and at the end of intervention, the subjects consume also a standard test meal to evaluate the postprandial response of glucose, insulin, lipids, oxidative parameters and inflammatory molecules.
Active Comparator: Refined cereal diet Treatment with a diet based on refined cereals and foods with high glycemic index	Other: Refined cereal diet Thirty subjects with metabolic syndrome, after an initial run-in period of 4 weeks, during which they stabilise their own diet and other lifestyle habits, are assigned to a diet based on refined cereals and foods with high glycemic index for a period of 12 weeks. Before and after the dietary treatment, a frequently samples intravenous glucose tolerance is carried out to measure the effects of the intervention on glucose and insulin metabolism. At beginning and at the end of intervention, the subjects consume also a standard test meal to evaluate the postprandial response of glucose, insulin, lipids, oxidative parameters and inflammatory molecules.

Arm

Intervention/treatment

Active Comparator: Wholegrain cereal diet

Treatment with a diet based on wholegrain cereals and foods with low glycemic index

Other: Wholegrain cereal diet

Thirty subjects with metabolic syndrome, after an initial run-in period of 4 weeks, during which they stabilise their own diet and other lifestyle habits, are assigned to a diet based on wholegrain cereals and foods with low glycemic index for a period of 12 weeks. Before and after the dietary treatment, a frequently samples intravenous glucose tolerance is carried out to measure the effects of the intervention on glucose and insulin metabolism. At beginning and at the end of intervention, the subjects consume also a standard test meal to evaluate the postprandial response of glucose, insulin, lipids, oxidative parameters and inflammatory molecules.

Active Comparator: Refined cereal diet

Treatment with a diet based on refined cereals and foods with high glycemic index

Other: Refined cereal diet

Thirty subjects with metabolic syndrome, after an initial run-in period of 4 weeks, during which they stabilise their own diet and other lifestyle habits, are assigned to a diet based on refined cereals and foods with high glycemic index for a period of 12 weeks. Before and after the dietary treatment, a frequently samples intravenous glucose tolerance is carried out to measure the effects of the intervention on glucose and insulin metabolism. At beginning and at the end of intervention, the subjects consume also a standard test meal to evaluate the postprandial response of glucose, insulin, lipids, oxidative parameters and inflammatory molecules.

Outcome Measures

Primary Outcome Measures :

Insulin Sensitivity (Si) [ Time Frame: 12 weeks ]
Peripheral insulin sensitivity was assessed by FSIGT. A glucose dose of 300 mg/kg body weight was given intravenously followed by a bolus of 0.03 U/kg of insulin injected after 20 min. Blood samples were frequently collected for 3 h for the measurement of plasma glucose and serum insulin concentrations, utilized to calculate the insulin sensitivity index Si

Secondary Outcome Measures :

Postprandial Insulin Changes [ Time Frame: 12 weeks ]
Blood samples during the standard meal test were drawn from an antecubital vein after a 12 h overnight fast and 0, 30, 60, 90, 120, 150 and 180 min postprandial for the measurement of plasma insulin response reported as average mean postprandial increment.
Postprandial Plasma Lipid Changes [ Time Frame: 12 weeks ]
Blood samples during the standard meal test were drawn from an antecubital vein after a 12 h overnight fast and 0, 30, 60, 90, 120, 150 and 180 min postprandial for the measurement of triglyceride response reported as average mean postprandial increment.

Eligibility Criteria

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Ages Eligible for Study:	40 Years to 70 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects with at least three of the following criteria of metabolic syndrome according to ATPIII-NCEP criteria:
1. waist circumference >102 for men and 88 for women,
2. fasting total serum triacyglycerol concentration >1.7 mmol/L,
3. fasting HDL cholesterol <1.0 mmol/L for men or <1.3 mmol/L for women,
4. IFG (plasma glucose between 6.1 and 6.9 mmol/L) or
5. blood pressure >130/85 mmHg or use of blood pressure medication
Hypertension in stable control (BP <135/80 mmHg) by means of drugs, which will not be allowed to be changed during the study
Absence of main cardiovascular events (IMA, Ictus)

Exclusion Criteria:

Diabetes mellitus diagnosed according to history of diabetes or blood glucose ≥ 200 mg/dL (11.1 mmol/L) 2 hours after a 75 g Oral glucose tolerance test (OGTT) to be performed during the run-in period in all the subjects
Any drug able to influence glucose and lipid metabolism (hypolipidemic drugs, cholesterol lowering foodstuffs, anti-inflammatory drugs)
Renal failure (serum creatinine > 1.5 mg/dL) and liver failure (ALT/AST> 2 times above normal values)
Anemia (Hb < 12g/dl) or any other chronic disease

Contacts and Locations

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): NCT00945854

Locations

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Italy
Dept. of Clinical and Experimental Medicine, Federico II University
Naples, Italy, 80131

Sponsors and Collaborators

Federico II University

Investigators

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Study Chair:	Gabriele Riccardi, Prof.	Dept. of Clinical and Experimental Medicine, Federico II University

More Information

Publications:

Giacco R, Clemente G, Cipriano D, Luongo D, Viscovo D, Patti L, Di Marino L, Giacco A, Naviglio D, Bianchi MA, Ciati R, Brighenti F, Rivellese AA, Riccardi G. Effects of the regular consumption of wholemeal wheat foods on cardiovascular risk factors in healthy people. Nutr Metab Cardiovasc Dis. 2010 Mar;20(3):186-94. doi: 10.1016/j.numecd.2009.03.025. Epub 2009 Jun 7.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Costabile G, Vetrani C, Bozzetto L, Giacco R, Bresciani L, Del Rio D, Vitale M, Della Pepa G, Brighenti F, Riccardi G, Rivellese AA, Annuzzi G. Plasma TMAO increase after healthy diets: results from 2 randomized controlled trials with dietary fish, polyphenols, and whole-grain cereals. Am J Clin Nutr. 2021 Oct 4;114(4):1342-1350. doi: 10.1093/ajcn/nqab188.

Vitale M, Hanhineva K, Koistinen V, Auriola S, Paananen J, Costabile G, Della Pepa G, Rivellese AA, Riccardi G, Giacco R. Putative metabolites involved in the beneficial effects of wholegrain cereal: Nontargeted metabolite profiling approach. Nutr Metab Cardiovasc Dis. 2021 Apr 9;31(4):1156-1165. doi: 10.1016/j.numecd.2020.12.022. Epub 2020 Dec 30.

Polito R, Costabile G, Nigro E, Giacco R, Vetrani C, Anniballi G, Luongo D, Riccardi G, Daniele A, Annuzzi G. Nutritional factors influencing plasma adiponectin levels: results from a randomised controlled study with whole-grain cereals. Int J Food Sci Nutr. 2020 Jun;71(4):509-515. doi: 10.1080/09637486.2019.1680959. Epub 2019 Oct 22.

Kärkkäinen O, Lankinen MA, Vitale M, Jokkala J, Leppänen J, Koistinen V, Lehtonen M, Giacco R, Rosa-Sibakov N, Micard V, Rivellese AAA, Schwab U, Mykkänen H, Uusitupa M, Kolehmainen M, Riccardi G, Poutanen K, Auriola S, Hanhineva K. Diets rich in whole grains increase betainized compounds associated with glucose metabolism. Am J Clin Nutr. 2018 Nov 1;108(5):971-979. doi: 10.1093/ajcn/nqy169.

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Responsible Party:	rivellese angela, prof, Federico II University
ClinicalTrials.gov Identifier:	NCT00945854
Other Study ID Numbers:	04022009 European Community
First Posted:	July 24, 2009 Key Record Dates
Results First Posted:	June 26, 2014
Last Update Posted:	June 26, 2014
Last Verified:	May 2014

Keywords provided by rivellese angela, Federico II University:


wholegrain cereals glycemic index metabolic syndrome insulin sensitivity

Additional relevant MeSH terms:

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Metabolic Syndrome Insulin Resistance Hypersensitivity Syndrome Disease	Pathologic Processes Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases Immune System Diseases

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