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Wholegrain Cereal Diet and Insulin Sensitivity

Primary Purpose

Metabolic Syndrome

Status

Completed

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Wholegrain cereal diet

Refined cereal diet

About this trial

This is an interventional treatment trial for Metabolic Syndrome focused on measuring wholegrain cereals, glycemic index, metabolic syndrome, insulin sensitivity

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Dept. of Clinical and Experimental Medicine, Federico II University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Wholegrain cereal diet

Refined cereal diet

Arm Description

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

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

Outcomes

Primary Outcome Measures

Insulin Sensitivity (Si)

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

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

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.

Full Information

NCT ID

NCT00945854

First Posted

July 22, 2009

Last Updated

May 26, 2014

Sponsor

Federico II University

1. Study Identification

Unique Protocol Identification Number

NCT00945854

Brief Title

Wholegrain Cereal Diet and Insulin Sensitivity

Official Title

Effect of Whole Grain Rich Diet on Insulin Sensitivity in Individuals With Metabolic Syndrome

Study Type

Interventional

2. Study Status

Record Verification Date

May 2014

Overall Recruitment Status

Completed

Study Start Date

March 2008 (undefined)

Primary Completion Date

March 2009 (Actual)

Study Completion Date

December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Federico II University

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metabolic Syndrome

Keywords

wholegrain cereals, glycemic index, metabolic syndrome, insulin sensitivity

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Wholegrain cereal diet

Arm Type

Active Comparator

Arm Description

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

Arm Title

Refined cereal diet

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Wholegrain cereal diet

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Refined cereal diet

Intervention Description

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.

Primary Outcome Measure Information:

Title

Insulin Sensitivity (Si)

Description

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Postprandial Insulin Changes

Description

Time Frame

12 weeks

Title

Postprandial Plasma Lipid Changes

Description

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.

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects with at least three of the following criteria of metabolic syndrome according to ATPIII-NCEP criteria: waist circumference >102 for men and 88 for women, fasting total serum triacyglycerol concentration >1.7 mmol/L, fasting HDL cholesterol <1.0 mmol/L for men or <1.3 mmol/L for women, IFG (plasma glucose between 6.1 and 6.9 mmol/L) or 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gabriele Riccardi, Prof.

Organizational Affiliation

Dept. of Clinical and Experimental Medicine, Federico II University

Official's Role

Study Chair

Facility Information:

Facility Name

Dept. of Clinical and Experimental Medicine, Federico II University

City

Naples

ZIP/Postal Code

80131

Country

Italy

12. IPD Sharing Statement

Citations:

PubMed Identifier

19502018

Citation

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.

Results Reference

background

PubMed Identifier

34091663

Citation

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.

Results Reference

derived

PubMed Identifier

33589320

Citation

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.

Results Reference

derived

PubMed Identifier

31638838

Citation

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.

Results Reference

derived

PubMed Identifier

30256894

Citation

Karkkainen O, Lankinen MA, Vitale M, Jokkala J, Leppanen J, Koistinen V, Lehtonen M, Giacco R, Rosa-Sibakov N, Micard V, Rivellese AAA, Schwab U, Mykkanen 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.

Results Reference

derived

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Wholegrain Cereal Diet and Insulin Sensitivity

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