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Effects on Cognitive Functions and Mood of Food Products Rich in Polyphenols

L

Lund University

Status

Completed

Conditions

Cardiometabolic Risk Markers
Mood
Cognitive Performance

Treatments

Other: Flavanol rich food product

Study type

Interventional

Funder types

Other

Identifiers

NCT02243956
AFC-2013/619

Details and patient eligibility

About

The purpose of this study is to investigate effects of a selected food product rich in polyphenol on cognitive performance and mood.

Full 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. 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 the presently described project it is hypothesized that four weeks daily consumption of a product specific high in flavanols can improve metabolic risk variables and cognitive functions in healthy subjects.

The purpose is therefore to investigate effects of flavanols on cognitive functions and cardiometabolic risk, and to investigate relations between cardiometabolic risk markers and cognitive performance. The test product is a commonly used food product, known to be specifically rich in flavanols. The effects of the test product is compared with effects of a control product that is based on a similar food product but is lacking flavanols.

Test parameters:

Cognitive tests: Working memory tests (an oral test), selection attention test (measure also reaction time, a computerized test ), and stroop test (a computerized test.

Mood is determined for 6 different mood sensations using VAS scales.

Bio markers in blood: glucose regulation (glucose, insulin), markers of inflammation and oxidative stress (IL-6, MDA, oxLDL), blood lipids (total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides), vascular function (P-Selectin, PAI-1, NO), gut hormones involved in metabolism and satiety (PYY, GLP-1) gut hormon involved in mucosa integrity (GLP-2), markers of brain function (BDNF, neurotensin).

Blood pressure.

Enrollment

38 patients

Sex

All

Ages

50 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Healthy women and men
  • Between 50-70 years
  • BMI 19-25

Exclusion criteria

  • Metabolic diseases
  • Food allergies
  • Smoker

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

38 participants in 2 patient groups, including a placebo group

Flavanol rich food product
Experimental group
Description:
A portion of a common flavanol rich food product is consumed daily for 4 weeks
Treatment:
Other: Flavanol rich food product
Non-flavanol food product
Placebo Comparator group
Description:
A portion of a product similar to the experimental Product, but instead contains low amounts of flavanol, is consumed Daily for 4 weeks as a control.
Treatment:
Other: Flavanol rich food product

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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