Wholegrain Cereal Diet and Insulin Sensitivity

NCT00945854 | Completed Results

• 2 other identifiers: 04022009European Community
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome

Keywords

wholegrain cereals; glycemic index; metabolic syndrome; insulin sensitivity

Outcome Measures

Primary Outcomes (1)

• 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

  12 weeks

Secondary Outcomes (2)

• Postprandial Insulin Changes

  12 weeks

• Postprandial Plasma Lipid Changes

  12 weeks

Study Arms (2)

Wholegrain cereal diet

ACTIVE COMPARATOR

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

Other: Wholegrain cereal diet

Refined cereal diet

ACTIVE COMPARATOR

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

Other: Refined cereal diet

Interventions

Wholegrain cereal diet OTHER

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.

Wholegrain cereal diet

Refined cereal diet OTHER

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.

Refined cereal diet

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Dept. of Clinical and Experimental Medicine, Federico II University

Naples, 80131, Italy

Location

Related Publications (5)

• 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.

  PMID: 19502018 BACKGROUND

• 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.

  PMID: 34091663 DERIVED

• 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.

  PMID: 33589320 DERIVED

• 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.

  PMID: 31638838 DERIVED

• 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.

  PMID: 30256894 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome; Insulin Resistance

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Riccardi Gabriele
• Organization: Federico II University

riccardi@unina.it

+390817462117

Study Officials

• Gabriele Riccardi, Prof.

  Dept. of Clinical and Experimental Medicine, Federico II University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof

Study Record Dates

• First Submitted: July 22, 2009
• First Posted: July 24, 2009
• Study Start: March 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: December 1, 2010
• Last Updated: June 26, 2014
• Results First Posted: June 26, 2014

Record last verified: 2014-05

Locations

IT (1)