Whole Grain Polyphenol Bioavailability and Effects on Health
|ClinicalTrials.gov Identifier: NCT01293175|
Recruitment Status : Completed
First Posted : February 10, 2011
Last Update Posted : July 12, 2013
|Condition or disease||Intervention/treatment||Phase|
|Overweight||Dietary Supplement: Whole grains||Not Applicable|
Epidemiological evidence indicates that consumption of whole grains (WG) is associated with improved health and decreased risk for common chronic diseases. However there is paucity of intervention data regarding the beneficial effects of WG in vascular health and associated metabolic disorders.
From 2007 up to now five main intervention studies using WG were published. The results from these studies consistently showed no efficacy of WG to modify biochemical parameters in free-living subjects including WG in their habitual diet. Anyway some drawbacks could be found and mainly regarding subject compliance to the treatment and the type of WG-rich foods supplied.
Our working hypothesis is based on WG physiologically bioactive compounds mainly polyphenolic compounds such as ferulic acid (FA). FA is covalently bound to arabinoxylans constituting WG dietary fiber. This structure represents a natural way to carry polyphenol compounds, into the lower gut. A previous work indicated that intestinal microflora particularly Bifidobacteria and Lactobacilli is able to ferment WG polysaccharide moiety (prebiotic effect) and at the same time microbial esterases can release free phenolic acids. The free acids are adsorbed through the colon barrier into the blood. The slow and continuous release of phenolic acids, particularly FA, determines an increase of baseline level of FA in the blood of WG consumers. However no study correlated FA plasma concentration with health parameters such as biomarkers of inflammation, glucose metabolism and oxidative status which may be in turn associated to the CVD risk.
In this framework a controlled, parallel, two arm intervention study will be performed using a WG-rich product that will be selected from those commercially available for having a high content of FA (>500 mg/kg). The aim of this study is to evaluate the bioavailability of FA over a two month-treatment in overweight subjects and to correlate variation of FA plasma concentrations with biomarkers of oxidative (plasma antioxidant capacity, MDA) and inflammatory (CRP, anti- and pro-inflammatory cytokines) status, with nutritional status and with gastro-intestinal hormones related to appetite and glucose metabolism (ghrelin, PYY, PP, insulin, GLP-1, GIP and leptin). Eighty subjects will be selected in the respect of strict inclusion and exclusion criteria and will be randomized to include WG in opportunely revised individual habitual diet, or to continue with their habitual diet. At baseline, after 1 month and after 2 months from starting the protocol, blood drawings will be performed and urine and feces will be collected from fasting subjects. Gastro-intestinal hormone response and glucose metabolism following a standard meal will be also evaluated at baseline and at 2 months.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Whole Grain Polyphenol Bioavailability and Effects on Inflammatory, Oxidative and Hormonal Status|
|Study Start Date :||February 2011|
|Actual Primary Completion Date :||February 2012|
|Actual Study Completion Date :||August 2012|
Experimental: Whole grains
Subjects will consume whole grains every day for two months
Dietary Supplement: Whole grains
Subjects will consume whole grains at dose of 80 g/die, for two months
No Intervention: Control
Subjects will consume their habitual diet
- Variation of serum polyphenol concentration [ Time Frame: 1 year ]Measure of serum polyphenol concentration (nmol/L)
- Variation of plasma lipids [ Time Frame: 1 year ]Measure of plasma concentrations (mg/dL) of Total-, LDL-, and HDL-Cholesterol, as well as Triglycerides
- Variation of serum antioxidant capacity [ Time Frame: 1 year ]Measure of plasma FRAP (µmol/L) and MDA (µmol/L) concentrations.
- Variation of body weight [ Time Frame: 1 year ]Measure of body weight (kg)
- Variation of serum inflammatory marker concentration [ Time Frame: 1 year ]Measure of serum CRP, IL-6, TNF-α, PAI-1, Visfatin, Resistin concentration (pg/mL)
- Variation of fecal microbiota composition [ Time Frame: 1 year ]By FISH (colony-forming unit, CFU/g)
- Variation of serum gastro-intestinal hormone concentration [ Time Frame: 1 year ]It will be evaluated following a standard meal test. In particular plasma response (pg/mL) of Ghrelin, PYY, Leptin, GIP, GLP-1, PP and insulin will be assessed
- Variation of blood pressure [ Time Frame: 1 year ]Measure of blood pressure (mmHg)
- Variation of body circumferences [ Time Frame: 1 year ]Measure of waist and hip circumferences (mm)
- Variation of body composition [ Time Frame: 1 year ]Measure of body composition (% of lean and fat mass, % water)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01293175
|Department of Food Science|
|Portici, Italy, 80055|
|Study Director:||Vincenzo Fogliano, Prof||University of Naples|
|Principal Investigator:||Paola Vitaglione, Dr||University of Naples|