Clinical trial NCT00945854: 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
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Keywords: wholegrain cereals
glycemic index
metabolic syndrome
insulin sensitivity
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2009-07-24
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Insulin Sensitivity (Si)
timeFrame: 12 weeks
Secondary outcomes:
measure: Postprandial Insulin Changes
timeFrame: 12 weeks
measure: Postprandial Plasma Lipid Changes
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Dept. of Clinical and Experimental Medicine, Federico II University
Study officials:
affiliation: Dept. of Clinical and Experimental Medicine, Federico II University
name: Gabriele Riccardi, Prof.
role: STUDY_CHAIR
References:
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.
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.
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.
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.
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.