Whole Grain Polyphenol Bioavailability and Effects on Health

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Paola Vitaglione, Federico II University
ClinicalTrials.gov Identifier:
NCT01293175
First received: February 9, 2011
Last updated: July 11, 2013
Last verified: July 2013
  Purpose

Whole grains (WG) contain numerous physiologically bioactive compounds, a key group being polyphenolic compounds such as ferulic acid (FA). These whole grain polyphenolic compounds have been shown to have potent antioxidant activity. This study will evaluate bioavailability of WG bioactive compounds and their physiological impact on health outcomes, mainly related to inflammatory, oxidative and hormonal status, in overweight subjects.


Condition Intervention
Overweight
Dietary Supplement: Whole grains

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Whole Grain Polyphenol Bioavailability and Effects on Inflammatory, Oxidative and Hormonal Status

Resource links provided by NLM:


Further study details as provided by Federico II University:

Primary Outcome Measures:
  • Variation of serum polyphenol concentration [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Measure of serum polyphenol concentration (nmol/L)

  • Variation of plasma lipids [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Measure of plasma concentrations (mg/dL) of Total-, LDL-, and HDL-Cholesterol, as well as Triglycerides


Secondary Outcome Measures:
  • Variation of serum antioxidant capacity [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Measure of plasma FRAP (µmol/L) and MDA (µmol/L) concentrations.

  • Variation of body weight [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Measure of body weight (kg)

  • Variation of serum inflammatory marker concentration [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Measure of serum CRP, IL-6, TNF-α, PAI-1, Visfatin, Resistin concentration (pg/mL)

  • Variation of fecal microbiota composition [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    By FISH (colony-forming unit, CFU/g)

  • Variation of serum gastro-intestinal hormone concentration [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Measure of blood pressure (mmHg)

  • Variation of body circumferences [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Measure of waist and hip circumferences (mm)

  • Variation of body composition [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Measure of body composition (% of lean and fat mass, % water)


Enrollment: 80
Study Start Date: February 2011
Study Completion Date: August 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18 - 60 years old, male and female
  • Healthy by medical assessment
  • Overweight: BMI > 25 and < 32 kg/m2
  • Habitual diet characterized by i) absence of WG (all dietary carbohydrates derived from refined cereals); ii) absence of pro-biotics; iii) intake of dietary fibre ≤ 10 g/d; iv) intake of fruit and vegetables ≤ 2 portions/die; v)habit to have breakfast
  • Sign of a written informed consent

Exclusion Criteria:

  • Age < 18 and > 60 years old
  • Pregnancy or breastfeeding
  • Fasting plasma triglycerides ≥ 200 mg/dl and cholesterol > 200 mg/dl
  • Cardiovascular events (AMI and/or stroke) in the last 6 months
  • Regular intensive physical activity
  • Hypertension
  • Intestinal or metabolic diseases/disorders such as diabetic, renal, hepatic, pancreatic or ulcer
  • Previous abdominal/gastrointestinal surgery
  • Regular consumption of medication
  • Antibiotic therapy within 2 months previous the study
  • Food allergies and intolerances (celiac disease, lactose intolerance,)
  • Concurrent participation or having participated in another clinical trial during the last 3 weeks
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01293175

Locations
Italy
Department of Food Science
Portici, Italy, 80055
Sponsors and Collaborators
Federico II University
Investigators
Study Director: Vincenzo Fogliano, Prof University of Naples
Principal Investigator: Paola Vitaglione, Dr University of Naples
  More Information

No publications provided

Responsible Party: Paola Vitaglione, Dr, Federico II University
ClinicalTrials.gov Identifier: NCT01293175     History of Changes
Other Study ID Numbers: DSA-FF-002
Study First Received: February 9, 2011
Last Updated: July 11, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by Federico II University:
whole grains
polyphenols
overweight
bioavailability
antioxidant status
inflammation

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014