OverweightNCT01293175
Whole Grain Polyphenol Bioavailability and Effects on Health
A study testing Whole grains in people with Overweight, run by Federico II University at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight
- What is being tested?
- Whole grains
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2011to Aug 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Whole Grain Polyphenol Bioavailability and Effects on Inflammatory, Oxidative and Hormonal Status
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.
Read the 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.
- Conditions
- Overweight
- Being tested
- Whole grains
- Keywords
- whole grains, polyphenols, overweight, bioavailability, antioxidant status, inflammation
- Medical subject headings
- Overweight, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole grainsDietary supplement
Subjects will consume whole grains at dose of 80 g/die, for two months
| Study group | Role | What they receive |
|---|---|---|
| Whole grains | Experimental | Subjects will consume whole grains every day for two months Receives: Dietary Supplement: Whole grains |
| Control | No intervention | Subjects will consume their habitual diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of serum polyphenol concentration
Measure of serum polyphenol concentration (nmol/L)
Measured: 1 year
Variation of plasma lipids
Measure of plasma concentrations (mg/dL) of Total-, LDL-, and HDL-Cholesterol, as well as Triglycerides
Measured: 1 year
Secondary outcomes (8)
Variation of serum antioxidant capacity
Measure of plasma FRAP (µmol/L) and MDA (µmol/L) concentrations.
Measured: 1 year
Variation of body weight
Measure of body weight (kg)
Measured: 1 year
Variation of serum inflammatory marker concentration
Measure of serum CRP, IL-6, TNF-α, PAI-1, Visfatin, Resistin concentration (pg/mL)
Measured: 1 year
Variation of fecal microbiota composition
By FISH (colony-forming unit, CFU/g)
Measured: 1 year
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
Measured: 1 year
Variation of blood pressure
Measure of blood pressure (mmHg)
Measured: 1 year
Variation of body circumferences
Measure of waist and hip circumferences (mm)
Measured: 1 year
Variation of body composition
Measure of body composition (% of lean and fat mass, % water)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionFeb 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paola Vitaglione, Federico II University
- Investigators
- Vincenzo Fogliano, Prof, Study director, University of NaplesPaola Vitaglione, Dr, Principal investigator, University of Naples
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01293175
- Sponsor's protocol ID
- DSA-FF-002
- Status last verified
- Jul 2013
- First submitted
- 9 Feb 2011
- Last updated
- 12 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25646321
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whole Grain Polyphenol Bioavailability and Effects on Inflammatory, Oxidative and Hormonal Status
- ClinicalTrials.gov ID
- NCT01293175
- Acronym / sponsor ID
- DSA-FF-002
- Conditions
- Overweight
- Keywords
- whole grains, polyphenols, overweight, bioavailability, antioxidant status, inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 10 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whole grains | Experimental | Dietary Supplement: Whole grainsSubjects will consume whole grains every day for two months |
| Control | No intervention | –Subjects will consume their habitual diet |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole grainsSubjects will consume whole grains at dose of 80 g/die, for two months | Dietary supplement | Whole grains |
Primary outcome
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
8 secondary outcomes
Variation of serum antioxidant capacity
Time frame: 1 year
Variation of body weight
Time frame: 1 year
Variation of serum inflammatory marker concentration
Time frame: 1 year
Variation of fecal microbiota composition
Time frame: 1 year
Variation of serum gastro-intestinal hormone concentration
Time frame: 1 year
Variation of blood pressure
Time frame: 1 year
Variation of body circumferences
Time frame: 1 year
Variation of body composition
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2013.
- Derived from this study: PubMed 25646321Vitaglione 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincenzo Fogliano, Prof study director
University of Naples
Paola Vitaglione, Dr principal investigator
University of Naples
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole grains in people with Overweight, run by Federico II University at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation of serum polyphenol concentration (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01293175, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2013.