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Effects of Sweetness on Neurocognitive Responses, Glycemia and Food Intake

12 lutego 2019 zaktualizowane przez: Nikoleta Stamataki, University of Manchester

The Impact of Dietary Sweetness on Neurocognitive Responses to Visual Food Cues, Appetite and Physiological Parameters on Normal Weight Adults: a Pilot Study

This study aims to examine potential differences in neurocognitive responses to food-related cues, physiological and appetite responses as well as subsequent energy intake following the consumption of preloads differing in sweetness and/ or postprandial metabolic effects in healthy normal weight subjects.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

Excess consumption of caloric sweeteners, together with the high availability of palatable food cues are some of the factors for the alarming high rates of overweight and obesity. Although non-nutritive sweeteners (NNS) are used to decrease energy content of foods and beverages, there is an on-going debate on the relationship between NNS intake, obesity and cardiometabolic risk. Caloric sugars have a differing effect on physiological responses compared to NNS. However it is almost wholly unknown how NNS consumption affects eating behaviour and cognitive processes.

This study compares the performance on food related neurocognitive tasks following the consumption of the test preloads on 5 visits. In particular, sucrose, glucose, maltodextrin, water or a natural high potency sweetener from leaf extract will be ingested as single test agents in randomized order. Water will be used as a control for gastric distension and non-sweet, whereas maltodextrin will be used as a non-sweet control for carbohydrate content.

Participants will be asked to attend a screening visit at the Neuroscience and Psychiatry Unit of the University of Manchester on a morning after overnight fast. Participants' weight and height, fasting blood glucose and blood pressure will be measured. This will be followed by some questionnaires regarding general health status, weight and dieting history and eating behaviour.

Participants who satisfy the inclusion criteria, will be then invited to take part in the full study. This will require 5 separate visits at the University of Manchester, which will be scheduled between 11.30 and 13.30. Participants will have to attend these visits after having fasted for 3-4 hours and will be asked to have their regular breakfast in the morning before the testing session, and then not eat or drink anything else for 3-4 hours until they come in the lab for the testing session. Water will be allowed up to 1 hour prior to your testing session. Prior to each testing session participants will be asked to have the same breakfast, and they will have to provide a picture of the breakfast each time to ensure compliance.

The 5 visits correspond to 5 test beverages, both the participants and the investigators are blinded to the study treatments. Blood will be collected at 0 (before the consumption of the test beverage), 15, 30 and 60 min after the consumption of the drink. Participants will also be asked to rate their feeling of hunger, fullness etc using visual analogue scales (VAS) at the same time points 0, 15, 30 and 60 min.

Fifteen min after the consumption of the drink, participants will complete a set of computer-based tasks. They are designed to capture behaviour in response to food cue presentation. This will last approximately 15 min.

Thirty min after the consumption of the drink, a lunch buffet will be served and participants will be free to eat as much or as little as they like until feeling comfortably full. Each session is anticipated to last for approximately 1 hour.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

20

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat do 40 lat (Dorosły)

Akceptuje zdrowych ochotników

Tak

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria:

  • Age 18 - 40 years
  • BMI between 18.5-24.9 kg/m2
  • DEBQ for restraint eating ≤ 3
  • Healthy - general good health
  • Currently not taking any medication (other than females taking the oral contraceptives)
  • Normal or corrected vision
  • Regular breakfast eaters (≥5 times per week)
  • Stable weight, ≤ 5 kg last 12 months
  • Fasting blood glucose ≤6.0 mmol/L
  • No self-reported food allergy or intolerance to foods supplied during the study
  • The participant is capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
  • The participant is able to read, comprehend and record information written in English.
  • A signed and dated written informed consent is obtained from the participant.

Exclusion Criteria:

  • Age under 18 years or over 40 years old.
  • BMI ≥25 kg/m2 and <18.5kg/m2
  • Subjects who are currently on a diet
  • Subjects who follow special diets for weight maintenance, such as Atkins Diet, Weight Watchers, gluten-free diet, The Zone diet, Vegetarian Diet, Raw Food Diet etc.
  • Subjects having breakfast fewer than 5 times per week.
  • Vegetarians, vegans.
  • Presence of any chronic condition requiring medication that might affect our results (e.g. diabetes, mental diseases, gastrointestinal diseases)
  • Subjects with eating disorders (binge eating disorder, bulimia etc)
  • Subjects who are currently experiencing anxiety or depression.
  • Subjects who do not have normal vision and do not correct it with glasses or contact lenses.
  • Participants who drink more than the NHS guidelines (14 units per week)
  • Female participants who are, or may be, pregnant, or currently lactating.
  • Subjects who regularly consume dietary supplements for weight loss, muscle building etc.
  • Subjects who have aversions to foods related with the study.
  • Subjects with food allergies or intolerance related with the foods/ drinks of the study.
  • Habitual NNS consumers, >1 can of diet beverage or >1 table packet of sweeteners per week.
  • Fasting blood glucose measured > 6 mmol/L at screening visit, according to diabetes.co.uk recommendations.
  • The participant cannot read, comprehend and record information written in English.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Podstawowa nauka
  • Przydział: Randomizowane
  • Model interwencyjny: Zadanie krzyżowe
  • Maskowanie: Potroić

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Komparator placebo: Water
Beverage containing either water, glucose, sucrose, maltodextrin or a natural high potency sweetener from leaf extract
Suplement diety: Water

Upon arrival, participant's blood will be collected at 0 (before the consumption of the test beverage), 15, 30 and 60 min after the consumption of the drink. Participants will rate their feelings of hunger, fullness etc using VAS at 0, 15, 30 and 60 min.

Fifteen min after the consumption of the drink, participants will complete a set of computer-based tasks designed to capture behaviour in response to food cue presentation. Thirty min after the consumption of the drink, a lunch buffet will be served and participants will be free to eat as much or as little as they like until feeling comfortably full.
Eksperymentalny: Natural high potency sweetener from leaf extract
Beverage containing either water, glucose, sucrose, maltodextrin or a natural high potency sweetener from leaf extract
Suplement diety: Natural high potency sweetener from leaf extract

Upon arrival, participant's blood will be collected at 0 (before the consumption of the test beverage), 15, 30 and 60 min after the consumption of the drink. Participants will rate their feelings of hunger, fullness etc using VAS at 0, 15, 30 and 60 min.

Fifteen min after the consumption of the drink, participants will complete a set of computer-based tasks designed to capture behaviour in response to food cue presentation. Thirty min after the consumption of the drink, a lunch buffet will be served and participants will be free to eat as much or as little as they like until feeling comfortably full.
Eksperymentalny: Glucose
Beverage containing either water, glucose, sucrose, maltodextrin or a natural high potency sweetener from leaf extract
Suplement diety: Glucose

Upon arrival, participant's blood will be collected at 0 (before the consumption of the test beverage), 15, 30 and 60 min after the consumption of the drink. Participants will rate their feelings of hunger, fullness etc using VAS at 0, 15, 30 and 60 min.

Fifteen min after the consumption of the drink, participants will complete a set of computer-based tasks designed to capture behaviour in response to food cue presentation. Thirty min after the consumption of the drink, a lunch buffet will be served and participants will be free to eat as much or as little as they like until feeling comfortably full.
Eksperymentalny: Sucrose
Beverage containing either water, glucose, sucrose, maltodextrin or a natural high potency sweetener from leaf extract
Suplement diety: Sucrose

Upon arrival, participant's blood will be collected at 0 (before the consumption of the test beverage), 15, 30 and 60 min after the consumption of the drink. Participants will rate their feelings of hunger, fullness etc using VAS at 0, 15, 30 and 60 min.

Fifteen min after the consumption of the drink, participants will complete a set of computer-based tasks designed to capture behaviour in response to food cue presentation. Thirty min after the consumption of the drink, a lunch buffet will be served and participants will be free to eat as much or as little as they like until feeling comfortably full.
Eksperymentalny: Maltodextrin
Beverage containing either water, glucose, sucrose, maltodextrin or a natural high potency sweetener from leaf extract
Suplement diety: Maltodextrin

Upon arrival, participant's blood will be collected at 0 (before the consumption of the test beverage), 15, 30 and 60 min after the consumption of the drink. Participants will rate their feelings of hunger, fullness etc using VAS at 0, 15, 30 and 60 min.

Fifteen min after the consumption of the drink, participants will complete a set of computer-based tasks designed to capture behaviour in response to food cue presentation. Thirty min after the consumption of the drink, a lunch buffet will be served and participants will be free to eat as much or as little as they like until feeling comfortably full.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Energy intake
Ramy czasowe: 1 hour
Examine how the consumption of sweet vs. non- sweet and energy-containing vs. non-energy containing preloads affects energy intake (kcal) in healthy lean individuals.
1 hour
Appetite ratings
Ramy czasowe: 1 hour
Examine how the consumption of sweet vs. non- sweet and energy-containing vs. non-energy containing preloads affects appetite ratings (VAS scales) in healthy lean individuals.
1 hour
Food-cue responses
Ramy czasowe: 1 hour
Examine how the consumption of sweet vs. non- sweet and energy-containing vs. non-energy containing preloads affects food-cue responses (reaction times) in healthy lean individuals.
1 hour
Blood glucose levels
Ramy czasowe: 1 hour
Examine how the consumption of sweet vs. non- sweet and energy-containing vs. non-energy containing preloads affects blood glucose levels (mmol/L) in healthy lean individuals.
1 hour

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Hedonic ratings
Ramy czasowe: 1 hour
Examine how participants rate the hedonic attributes of the test beverages (Sweetness, pleasantness, etc) and the meal
1 hour

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

University of Manchester

Współpracownicy

Cargill

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

26 kwietnia 2018

Zakończenie podstawowe (Rzeczywisty)

15 października 2018

Ukończenie studiów (Rzeczywisty)

15 listopada 2018

Daty rejestracji na studia

Pierwszy przesłany

8 października 2018

Pierwszy przesłany, który spełnia kryteria kontroli jakości

16 października 2018

Pierwszy wysłany (Rzeczywisty)

18 października 2018

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

15 lutego 2019

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

12 lutego 2019

Ostatnia weryfikacja

1 lutego 2019

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Inne numery identyfikacyjne badania

  • 2310 (CTEP)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIEZDECYDOWANY

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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