NCT02243956

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 10, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 18, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

September 8, 2017

Status Verified

September 1, 2017

Enrollment Period

1.2 years

First QC Date

September 10, 2014

Last Update Submit

September 6, 2017

Conditions

Cognitive PerformanceMoodCardiometabolic Risk Markers

Outcome Measures

Primary Outcomes (1)

  • working memory (WM) capacity

    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.

    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.

Secondary Outcomes (1)

  • 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.

Other Outcomes (10)

  • blood pressure

    Each of the two intervention periods is 4 weeks. At the first and last day in each intervention periods, blood pressure is determined at fasting and four times in the postprandial phase up to 3,5h after breakfast.

  • glucose regulation

    Each of the two intervention periods is 4 weeks. At the first and last day in each intervention periods, blood glucose is determined fasting and then eight times in the postprandial phase up to 3.5h after the standardised breakfast

  • selective attention (SA)

    Each of the two intervention periods is 4 weeks. At the first and last day in each intervention periods, selective attention is determined three times in the postprandial phase up to 3.5h after the standardised breakfast

  • +7 more other outcomes

Study Arms (2)

Flavanol rich food product

EXPERIMENTAL

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

Other: Flavanol rich food product

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.

Other: Flavanol rich food product

Interventions

Flavanol rich food productOTHER

polyphenol rich test product

Flavanol rich food productNon-flavanol food product

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Metabolic diseases
  • Food allergies
  • Smoker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lund Univercity, Medicon village, Functional Food Science Centre

Lund, 223 81, Sweden

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Associate Professor

Study Record Dates

First Submitted

September 10, 2014

First Posted

September 18, 2014

Study Start

January 1, 2014

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

September 8, 2017

Record last verified: 2017-09

Locations

SE(1)