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

NCT ID: NCT02243956

Last Updated: 2017-09-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2015-03-31

Brief Summary

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

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. 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.

Conditions

Cognitive Performance; Mood; Cardiometabolic Risk Markers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Flavanol rich food product

A portion of a common flavanol rich food product is consumed daily for 4 weeks

Group Type: EXPERIMENTAL

Flavanol rich food product

Intervention Type: OTHER

polyphenol rich test product

Non-flavanol food product

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.

Group Type: PLACEBO_COMPARATOR

Flavanol rich food product

Intervention Type: OTHER

polyphenol rich test product

Interventions

Flavanol rich food product

polyphenol rich test product

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Metabolic diseases
• Food allergies
• Smoker

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Anti-Diabetic Food Centre

OTHER

Sponsor Role: collaborator

Lund University

OTHER

Sponsor Role: lead

Responsible Party

Anne Nilsson

PhD, Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Lund Univercity, Medicon village, Functional Food Science Centre

Lund, , Sweden

Countries

Sweden

Other Identifiers

AFC-2013/619

Identifier Type: -

Identifier Source: org_study_id