- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT02243956
Effects on Cognitive Functions and Mood of Food Products Rich in Polyphenols
Food Design for Improved Cognitive Performance/Effects on Cognitive Functions and Mood of Food Products Rich in Polyphenols
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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-
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Lund, Szwecja, 223 81
- Lund Univercity, Medicon village, Functional Food Science Centre
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Healthy women and men
- Between 50-70 years
- BMI 19-25
Exclusion Criteria:
- Metabolic diseases
- Food allergies
- Smoker
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Randomizowane
- Model interwencyjny: Zadanie krzyżowe
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: Flavanol rich food product
A portion of a common flavanol rich food product is consumed daily for 4 weeks
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polyphenol rich test product
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Komparator placebo: 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.
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polyphenol rich test product
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
working memory (WM) capacity
Ramy czasowe: 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.
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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.
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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.
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
mood assessment
Ramy czasowe: 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.
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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.
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Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
blood pressure
Ramy czasowe: 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.
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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.
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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.
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glucose regulation
Ramy czasowe: 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
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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.
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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
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selective attention (SA)
Ramy czasowe: 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
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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
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Vascular function
Ramy czasowe: 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
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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
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Blood lipids
Ramy czasowe: 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
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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
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Marker of inflammation
Ramy czasowe: 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
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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
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Markers of oxidative stress
Ramy czasowe: 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
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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
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Gut peptides
Ramy czasowe: 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
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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
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markers of brain function
Ramy czasowe: 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
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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
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Stroop test
Ramy czasowe: 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 .
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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 .
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Współpracownicy i badacze
Sponsor
Współpracownicy
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Inne numery identyfikacyjne badania
- AFC-2013/619
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