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Clinical Trials/NCT02243956
NCT02243956CompletedNot Applicable

Food Design for Improved Cognitive Performance/Effects on Cognitive Functions and Mood of Food Products Rich in Polyphenols

Lund University1 site in 1 country38 target enrollmentStarted: January 1, 2014Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
38
Locations
1
Primary Endpoint
working memory (WM) capacity

Study Overview

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:

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
50 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

  • •Metabolic diseases
  • •Food allergies

Arms & Interventions

Flavanol rich food product

Experimental

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

Intervention: Flavanol rich food product (Other)

Non-flavanol food product

Placebo Comparator

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.

Intervention: Flavanol rich food product (Other)

Outcomes

Primary Outcomes

working memory (WM) capacity

Time Frame: Each of the two intervention periods is 4 weeks. At the first and last day in each intervention periods, working memory capacity is determined four times in the postprandial phase up to 3.5h after breakfast.

The test food product or control is consumed fasting, and after 30 min a standardised breakfast is served. WM tests are performed at 60 min, 120 min, 165 min and 210 min after commencing the intake of test Product. One test takes approximately 8 min to carry out.

Secondary Outcomes

  • mood assessment(Each of the two intervention periods is 4 weeks. At the first and last day in each intervention periods, subjects registered mood sensations at fasting and five times in the postprandial phase up to 3,5h after breakfast.)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Anne Nilsson

PhD, Associate Professor

Lund University

Study Sites (1)

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