NCT01293175

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

February 9, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 10, 2011

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

July 12, 2013

Status Verified

July 1, 2013

Enrollment Period

1 year

First QC Date

February 9, 2011

Last Update Submit

July 11, 2013

Conditions

Overweight

Keywords

whole grainspolyphenolsoverweightbioavailabilityantioxidant statusinflammation

Outcome Measures

Primary Outcomes (2)

  • Variation of serum polyphenol concentration

    Measure of serum polyphenol concentration (nmol/L)

    1 year

  • Variation of plasma lipids

    Measure of plasma concentrations (mg/dL) of Total-, LDL-, and HDL-Cholesterol, as well as Triglycerides

    1 year

Secondary Outcomes (8)

  • Variation of serum antioxidant capacity

    1 year

  • Variation of body weight

    1 year

  • Variation of serum inflammatory marker concentration

    1 year

  • Variation of fecal microbiota composition

    1 year

  • Variation of serum gastro-intestinal hormone concentration

    1 year

  • +3 more secondary outcomes

Study Arms (2)

Whole grains

EXPERIMENTAL

Subjects will consume whole grains every day for two months

Dietary Supplement: Whole grains

Control

NO INTERVENTION

Subjects will consume their habitual diet

Interventions

Whole grainsDIETARY_SUPPLEMENT

Subjects will consume whole grains at dose of 80 g/die, for two months

Whole grains

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Food Science

Portici, 80055, Italy

Location

Related Publications (1)

  • 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.

    PMID: 25646321DERIVED

MeSH Terms

Conditions

OverweightInflammation

Interventions

Whole Grains

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Intervention Hierarchy (Ancestors)

Edible GrainCrops, AgriculturalFoodDiet, Food, and NutritionPhysiological PhenomenaSeedsFood and Beverages

Study Officials

  • Vincenzo Fogliano, Prof

    University of Naples

    STUDY DIRECTOR

  • Paola Vitaglione, Dr

    University of Naples

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

February 9, 2011

First Posted

February 10, 2011

Study Start

February 1, 2011

Primary Completion

February 1, 2012

Study Completion

August 1, 2012

Last Updated

July 12, 2013

Record last verified: 2013-07

Locations

IT(1)