Clinical Trials Directory

Trials / Completed

CompletedNCT01562392

Effects of Berries and Vegetables on Cardiometabolic Risk Markers and Cognitive Functions

Effects of 5 w Daily Intake of Berries and Vegetables on Cardiometabolic Risk Markers and Cognitive Functions

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
40 (estimated)
Sponsor
Lund University · Academic / Other
Sex
All
Age
50 Years – 70 Years
Healthy volunteers
Accepted

Summary

The purpose of the study is to study the potential anti-inflammatory- and metabolic effects of polyphenols and dietary fibres in a product based on a mixture of several Swedish berries and vegetables that is known to have high amounts of polyphenols and other anit-oxidants. In addition the purpose is to investigate the effects on cognitive functions of the berry product.

Detailed description

The metabolic syndrome (MetS) includes a cluster of dysfunctions that identifies subjects at risk of developing type-2 diabetes and cardiovascular disease (CVD). A key feature appears to be chronic increased inflammation and activation of the innate system. Consequently, increased low-grade inflammation has been connected to adverse effects on insulin sensitivity, glucose- and lipid metabolism, and blood pressure, and circulating markers of inflammation such as IL-6. A growing body of evidence also link low-grade inflammation to poorer cognitive functioning. Type 2 diabetes, MetS, and glucose intolerance are increasingly being associated with impaired cognition. Dietary patterns which promote sub-clinical inflammation are increasingly being considered predictive of future risk of CVD and type-2 diabetes. There is a growing insight regarding the role of the colonic micro flora in metabolic regulation and development of low-grade inflammation and obesity. The metabolic cross talk between the colon and peripheral tissues, especially adipose tissue, has been suggested to be regulated through colonic fermentation of indigestible carbohydrates e.g. dietary fibres (DF) and resistant starch. In addition, epidemiological data shows that a high consumption of vegetables and fruits is associated with a lowered risk of cancer and cardiovascular disease, which may be due to the high concentrations of polyphenols or other anti-oxidants that are found in such foods. In addition vegetables and berries are rich in dietary fibres with the potential to beneficially modulate the gut micro flora which may have implication on metabolic risk factors. In the presently described project it is hypothesized that 5 w daily consumption of a food product containing berries and vegetables can improve metabolic risk variables and cognitive functions. The purpose is therefore to study the potential anti-inflammatory- and metabolic effects, and prebiotic properties, of a food product based on a mixture of several Swedish berries and vegetables that is known to be rich in dietary fibres, polyphenols and other anti-oxidants. In addition the purpose is to investigate the effects on cognitive functions of the food product.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTberries and vegetablesDaily (5 w) supplementation with specific vegetables and berries
DIETARY_SUPPLEMENTcontrol productSupplementation (daily,5 w) with a control product without berries and vegetables.

Timeline

Start date
2011-09-01
Primary completion
2012-12-01
Completion
2013-01-01
First posted
2012-03-23
Last updated
2014-02-27

Locations

1 site across 1 country: Sweden

Source: ClinicalTrials.gov record NCT01562392. Inclusion in this directory is not an endorsement.