Study title
Effects of whole grain intake on cardiovascular risk factors in subject with metabolic syndrome
Template
Intervention/Observation study
title
Effects of whole grain intake on cardiovascular risk factors in subject with metabolic syndrome
description
The HEALTHGRAIN project aimed to improve the well-being and reduce the risk of metabolic syndrome related diseases in Europe by increasing the intake of protective compounds in whole grains or their fractions. The aim is to produce health promoting and safe cereal foods and ingredients of high eating quality. A whole grain diet is increasingly demonstrated to be protective against development of diet related disorders such as cardiovascular disease and type 2 diabetes. HEALTHGRAIN will carry out an integrated, multidisciplinary effort to establish the variation, process-induced changes and human metabolism of bioactive compounds in the major European bread grains, and to reveal the physiological mechanisms underlying their significance in prevention of metabolic syndrome and related diseases. The target bioactive compounds are vitamins (folate, tocols, choline etc.), phytochemicals (lignans, sterols, alkylresorcinols, phenolic acids) and indigestible carbohydrates. Also other product characteristics that may add to the metabolic benefits of whole grain products are promoted.
startDate
2008-01-01 00:00:00.0
Study type
Human Intervention
Principle Investigator
Riccardi Gabriele
Primary endpoint
Effect of wholegrain intake on peripheral insulin sensitivity
Objectives
The aim was to evaluate the effects of a 12-week intervention with either a whole-grain-based or a refined cereal based diet on postprandial glucose, insulin and lipid metabolism in individuals with metabolic syndrome.
Central conclusion
After 12 weeks of intervention, the diet rich in whole grains, compared to the control diet: 1) reduced by 29% and 43% the insulin and triglyceride responses, respectively, in the postprandial period; 2) did not modify the indexes of peripheral sensitivity and insulin secretion (SI, QUICKI, OF, dAIRG), and subclinical inflammation (CRP, TNF-a, IL etc); 3) increased plasma levels of propionic acid, a marker of intestinal fermentation, and this increase was associated with the reduction in postprandial insulin levels.
Main health-related outcome
cardiovascular risk factors
Exclusion criteria
•Fasting plasma triglycerides ≥400 mg/dl and cholesterol >270 mg/dl
•Cardiovascular events (AMI and/or stroke) in the last 6 months
•Diabetes mellitus
•Regular intensive physical activity
•Kidney (serum creatinine >1.7 mg/dl) and liver (transaminases >double)
•Hypolipidemic or antinflammatory drugs
•Anemia (Hb <12 g/dl) or any other chronic disease
Inclusion criteria
•bmi >25<35 kg/m2
•High waist circumference (men >102 cm, women >88 cm) + two of the following components of metabolic syndrome :
Fasting plasma triglycerides ≥150 mg/dl Fasting HDL-col <40 mg/dl (men) and <50 mg/dl (women) Fasting plasma glucose 100-125 mg/dl
Institute
ISA-CNR Avellino and "Federico II" University of Naples;
Country (for multicentre study overall PI)
Italy
Study weblink
https://www.healthgrain.org/eu_project/about
Clinicaltrials.gov or similar number
NCT00945854
Was the study approved by an ethics committee?
Yes
Ethical approval number
N/A
Did the individuals providing data sign informed consent?
Yes
Description of "Start groups"
N/A
Type of controls
Refined cereal-based diet
Compliance assessment (for each treatment)
Measurement of plasma alkylresorcinols and 7-day food records
Total number of arms (Give number of distinct treatments in study)
2
Number of volunteers screened N(M:xx, F: xx)
(M: 47, F: 64)
Number of volunteers enrolled N(M:xx, F: xx)
(M: 27, F: 34)
Number of subjects (Male; Female)
(M: 23, F: 31)
Start of recruitment (Start year or date)
2008-02-01 00:00:00.0
End of recruitment (End year or date)
2010-01-01 00:00:00.0
