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Whole Grain Polyphenol Bioavailability and Effects on Health

Primary Purpose

Overweight

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Whole grains
Sponsored by
Federico II University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight focused on measuring whole grains, polyphenols, overweight, bioavailability, antioxidant status, inflammation

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Food Science

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Whole grains

Control

Arm Description

Subjects will consume whole grains every day for two months

Subjects will consume their habitual diet

Outcomes

Primary Outcome Measures

Variation of serum polyphenol concentration
Measure of serum polyphenol concentration (nmol/L)
Variation of plasma lipids
Measure of plasma concentrations (mg/dL) of Total-, LDL-, and HDL-Cholesterol, as well as Triglycerides

Secondary Outcome Measures

Variation of serum antioxidant capacity
Measure of plasma FRAP (µmol/L) and MDA (µmol/L) concentrations.
Variation of body weight
Measure of body weight (kg)
Variation of serum inflammatory marker concentration
Measure of serum CRP, IL-6, TNF-α, PAI-1, Visfatin, Resistin concentration (pg/mL)
Variation of fecal microbiota composition
By FISH (colony-forming unit, CFU/g)
Variation of serum gastro-intestinal hormone concentration
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
Measure of blood pressure (mmHg)
Variation of body circumferences
Measure of waist and hip circumferences (mm)
Variation of body composition
Measure of body composition (% of lean and fat mass, % water)

Full Information

First Posted
February 9, 2011
Last Updated
July 11, 2013
Sponsor
Federico II University
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1. Study Identification

Unique Protocol Identification Number
NCT01293175
Brief Title
Whole Grain Polyphenol Bioavailability and Effects on Health
Official Title
Whole Grain Polyphenol Bioavailability and Effects on Inflammatory, Oxidative and Hormonal Status
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federico II University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight
Keywords
whole grains, polyphenols, overweight, bioavailability, antioxidant status, inflammation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Whole grains
Arm Type
Experimental
Arm Description
Subjects will consume whole grains every day for two months
Arm Title
Control
Arm Type
No Intervention
Arm Description
Subjects will consume their habitual diet
Intervention Type
Dietary Supplement
Intervention Name(s)
Whole grains
Intervention Description
Subjects will consume whole grains at dose of 80 g/die, for two months
Primary Outcome Measure Information:
Title
Variation of serum polyphenol concentration
Description
Measure of serum polyphenol concentration (nmol/L)
Time Frame
1 year
Title
Variation of plasma lipids
Description
Measure of plasma concentrations (mg/dL) of Total-, LDL-, and HDL-Cholesterol, as well as Triglycerides
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Variation of serum antioxidant capacity
Description
Measure of plasma FRAP (µmol/L) and MDA (µmol/L) concentrations.
Time Frame
1 year
Title
Variation of body weight
Description
Measure of body weight (kg)
Time Frame
1 year
Title
Variation of serum inflammatory marker concentration
Description
Measure of serum CRP, IL-6, TNF-α, PAI-1, Visfatin, Resistin concentration (pg/mL)
Time Frame
1 year
Title
Variation of fecal microbiota composition
Description
By FISH (colony-forming unit, CFU/g)
Time Frame
1 year
Title
Variation of serum gastro-intestinal hormone concentration
Description
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
Time Frame
1 year
Title
Variation of blood pressure
Description
Measure of blood pressure (mmHg)
Time Frame
1 year
Title
Variation of body circumferences
Description
Measure of waist and hip circumferences (mm)
Time Frame
1 year
Title
Variation of body composition
Description
Measure of body composition (% of lean and fat mass, % water)
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincenzo Fogliano, Prof
Organizational Affiliation
University of Naples
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Paola Vitaglione, Dr
Organizational Affiliation
University of Naples
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Food Science
City
Portici
ZIP/Postal Code
80055
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
25646321
Citation
Vitaglione P, Mennella I, Ferracane R, Rivellese AA, Giacco R, Ercolini D, Gibbons SM, La Storia A, Gilbert JA, Jonnalagadda S, Thielecke F, Gallo MA, Scalfi L, Fogliano V. Whole-grain wheat consumption reduces inflammation in a randomized controlled trial on overweight and obese subjects with unhealthy dietary and lifestyle behaviors: role of polyphenols bound to cereal dietary fiber. Am J Clin Nutr. 2015 Feb;101(2):251-61. doi: 10.3945/ajcn.114.088120. Epub 2014 Dec 3.
Results Reference
derived

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Whole Grain Polyphenol Bioavailability and Effects on Health

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