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

6. september 2017 opdateret af: Anne Nilsson, Lund University

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

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

Studieoversigt

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

38

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • Lund, Sverige, 223 81
        • Lund Univercity, Medicon village, Functional Food Science Centre

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

50 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

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

Exclusion Criteria:

  • Metabolic diseases
  • Food allergies
  • Smoker

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Flavanol rich food product
A portion of a common flavanol rich food product is consumed daily for 4 weeks
polyphenol rich test product
Placebo komparator: 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.
polyphenol rich test product

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
working memory (WM) capacity
Tidsramme: 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.
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.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
mood assessment
Tidsramme: 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.

Self-reported sensations of mood and feelings of activation was assessed with a modified bipolar variant of the Swedish Core Affect Scales (SCAS) comprising six rating scales of two orthogonal dimensions of core affect: valence (unpleasantness-pleasantness) and activation (quietness-excitement).

Mood scales are filled out at fasting, prior to the standardised breakfast served after 30 min and directly after cognitive tests started at 60 min, 120 min, 165 min and 210 min after commencing the intake of test product.

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.

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
blood pressure
Tidsramme: 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.
Blood pressure is determined at fasting and at 60 min, 90 min, 150 min and 180 min, prior to other test variables collected at the same test Point.
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
Tidsramme: 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
Blood glucose concentrations (determined in capillary blood), and insulin (determined in venous blood). Blood tests are collected repeatedly during 3h after a standardised breakfast consumed 30 min after commencing the test product/Control Product.
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)
Tidsramme: 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
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
Vascular function
Tidsramme: Each of the two intervention periods is 4 weeks. At the first and last day in each intervention periods, vascular marker is determined fasting and up to 3.5h after the standardised breakfast
Each of the two intervention periods is 4 weeks. At the first and last day in each intervention periods, vascular marker is determined fasting and up to 3.5h after the standardised breakfast
Blood lipids
Tidsramme: Each of the two intervention periods is 4 weeks. At the first and last day in each intervention periods, blood lipids are determined fasting and up to 3.5h after the standardised breakfast
Each of the two intervention periods is 4 weeks. At the first and last day in each intervention periods, blood lipids are determined fasting and up to 3.5h after the standardised breakfast
Marker of inflammation
Tidsramme: Each of the two intervention periods is 4 weeks. At the first and last day in each intervention periods, inflammatory markers in blood are determined fasting and up to 3.5h after the standardised breakfast
Each of the two intervention periods is 4 weeks. At the first and last day in each intervention periods, inflammatory markers in blood are determined fasting and up to 3.5h after the standardised breakfast
Markers of oxidative stress
Tidsramme: Each of the two intervention periods is 4 weeks. At the first and last day in each intervention periods, markers of oxidative stress are determined in blood at fasting and then up to 3.5h after a standised breakfast
Each of the two intervention periods is 4 weeks. At the first and last day in each intervention periods, markers of oxidative stress are determined in blood at fasting and then up to 3.5h after a standised breakfast
Gut peptides
Tidsramme: Each of the two intervention periods is 4 weeks. At the first and last day in each intervention periods, gut peptides are determined in blood at fasting
Each of the two intervention periods is 4 weeks. At the first and last day in each intervention periods, gut peptides are determined in blood at fasting
markers of brain function
Tidsramme: Each of the two intervention periods is 4 weeks. At the first and last day in each intervention periods, markers of brain finction are determined in blood at fasting
Each of the two intervention periods is 4 weeks. At the first and last day in each intervention periods, markers of brain finction are determined in blood at fasting
Stroop test
Tidsramme: Each of the two intervention periods is 4 weeks. At the first and last day Stroop tests are performed three times after a standardised breakfast up to 3,5h .
Each of the two intervention periods is 4 weeks. At the first and last day Stroop tests are performed three times after a standardised breakfast up to 3,5h .

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Samarbejdspartnere

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2014

Primær færdiggørelse (Faktiske)

1. marts 2015

Studieafslutning (Faktiske)

1. marts 2015

Datoer for studieregistrering

Først indsendt

10. september 2014

Først indsendt, der opfyldte QC-kriterier

17. september 2014

Først opslået (Skøn)

18. september 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. september 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. september 2017

Sidst verificeret

1. september 2017

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • AFC-2013/619

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