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Postprandial Glucose, Insulin and Subjective Saturation Response in Healthy Individuals

22 czerwca 2022 zaktualizowane przez: Özlem ÖZPAK AKKUŞ, Toros University

An Evaluation of the Effect of Grain-Like Products on Postprandial Glucose, Insulin and Subjective Saturation Response in Healthy Individuals

This study is a pioneering study in which the effect of the consumption of cakes produced with the addition of cereal-like products such as chia and flax seeds, which have high soluble fiber content, on blood glucose and insulin values, and the effect on the satiety response of individuals after consumption of cakes, will be a pioneer in many subjects.

As a result of the study, the relationships between the changes in the investigated parameters and the possible changes in these parameters will be revealed. The results obtained suggest that foods rich in soluble fiber such as chia and flaxseed and foods produced with the possible synergetic effect of chia and flaxseed are used in healthy and safe products suitable for our consumption habits, and that these products are both protective and protective against the development of complications such as obesity and type 2 diabetes, cardiovascular diseases. The investigators think that it may also play a role in preventing its progress.

Przegląd badań

Szczegółowy opis

The present study aimed to compare the effect of the consumption of the cake supplemented with cereal-like produces, such as chia or flaxseed, which have high soluble fiber content, on postprondial blood glucose and insulin values. It also aimed to evaluate its effect of individuals' saturation response after consumption, and to develop cake recipes involving chia and flax seed. The study is two-fold. In the preliminary study, the standard and test cakes (chia added cake, flax seed added cake, and chia+flax seed added cake) were developed and the amount of cake containing 50 g carbohydrate and the amount of moisture, ash, pulp, protein, fat, and digestible carbohydrate will be determined via analyses that will be carried at Toros University Food Chemistry Laboratory. Based on the results obtained, the amount of cakes containing 50 g digestible carbohydrate will be calculated and produced. In the main study, the effect of standard and test cakes containing 50 g digestible carbohydrates on postprandial blood glucose, insulin, and subjective saturation response will be investigated. The study will be conducted with 14 volunteers aged between 19 and years 64, with no acute or chronic disease, having a Body Mass Index (BMI) of 18.5-24.9 kg/m2, and with a Beck Depression Scale of 8 or less. Those using prescription drugs and/or fiber supplements, pregnant or lactating women, those consuming excessive alcohol (> 2 drinks/day), women in menstrual period, those having allergic reaction to chia or flaxseed will not be included in the study. Before the individuals are included in the study, anthropometric measurements will be taken, Beck Depression Scale will be administered in order to evaluate the depression status, and individuals will be informed about the purpose and content of the study, and signed Informed Consent Form will be obtained from all participants. The individuals participating in the study will come to the research center once a week for four weeks to consume the cakes. Individuals will stay hungry for 10-12 hours after eating their usual dinner the night before the test and they will only consume water during this period. Baseline/fasting appetite responses of the individuals who came to the research center after this fasting period will be measured with a 100-mm visual analog scale (VAS) and baseline/fasting blood samples will be taken. The cakes will be consumed within 10 minutes and appetite responses will be measured using the 100-mm Visual Analog Scala (VAS) at 15, 30, 60, 90, 120, 180 minutes, and then venous blood samples will be taken by the nurse-in-charge. During this three-hour period, the participants will not be allowed to leave the research center, nor will they be allowed to consume any other food. Blood samples will be analyzed at the Forum Yaşam Hospital Biochemistry Laboratory. Glucose values will be analyzed by UV test analysis and insulin values will be analyzed by the chemical immunoassay method. The data obtained will be compared with the appropriate statistical methods and interpreted in the light of the literature.

Typ studiów

Interwencyjne

Zapisy (Oczekiwany)

14

Faza

  • Nie dotyczy

Kontakty i lokalizacje

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

Kontakt w sprawie studiów

Lokalizacje studiów

      • Mersin, Indyk, 33040
        • Rekrutacyjny
        • Özlem ÖZPAK AKKUŞ
        • Kontakt:

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

19 lat do 64 lata (Dorosły)

Akceptuje zdrowych ochotników

Tak

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria:

  • The study will be conducted with 14 volunteers
  • Aged between 19 and years 64
  • No acute or chronic disease
  • Body Mass Index (BMI) of 18.5-24.9 kg/m2
  • Beck Depression Scale of 8 or less.

Exclusion Criteria:

  • Using prescription drugs and/or fiber supplements
  • Pregnant or lactating women
  • Consuming excessive alcohol (> 2 drinks/day)
  • Women in menstrual period
  • Having allergic reaction to chia or flaxseed

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: Leczenie podtrzymujące
  • Przydział: Nielosowe
  • Model interwencyjny: Zadanie krzyżowe
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Brak interwencji: Nutritional analyzes applied to four cakes
The study is two-fold. In the preliminary study, the standard and test cakes (chia added cake, flax seed added cake, and chia+flax seed added cake) were developed and the amount of cake containing 50 g carbohydrate and the amount of moisture, ash, pulp, protein, fat, and digestible carbohydrate will be determined via analyses that will be carried at Toros University Food Chemistry Laboratory. Based on the results obtained, the amount of cakes containing 50 g digestible carbohydrate will be calculated and produced.
Eksperymentalny: Flaxseed cake
Measuring blood glucose levels, plasma insulin and the satiety response levels of individuals after consumption of flaxseed cake
Measuring blood glucose levels, plasma insulin and the satiety response levels of individuals after consumption of flaxseed, chia, flaxseed + chia and standart cakes
Eksperymentalny: Chia cake
Measuring blood glucose levels, plasma insulin and the satiety response levels of individuals after consumption of chia cake
Measuring blood glucose levels, plasma insulin and the satiety response levels of individuals after consumption of flaxseed, chia, flaxseed + chia and standart cakes
Eksperymentalny: Flaxseed and chia cake
Measuring blood glucose levels, plasma insulin and the satiety response levels of individuals after consumption of flaxseed and chia cake
Measuring blood glucose levels, plasma insulin and the satiety response levels of individuals after consumption of flaxseed, chia, flaxseed + chia and standart cakes
Eksperymentalny: Standart
Measuring blood glucose levels, plasma insulin and the satiety response levels of individuals after consumption of standart cake
Measuring blood glucose levels, plasma insulin and the satiety response levels of individuals after consumption of flaxseed, chia, flaxseed + chia and standart cakes

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Flax Seed Cake and Blood Glucose Parameters
Ramy czasowe: One day
Measurement of blood glucose parameters seven times (0. minute, 15. minute, 30. minute, 60. minute, 90. minute, 120. minute, 180. minute) within three hours after consumption of flax seed cake.
One day
Flax Seed Cake and Plasma Insulin Levels
Ramy czasowe: One day
Measurement of plasma insulin levels seven times (0. minute, 15. minute, 30. minute, 60. minute, 90. minute, 120. minute, 180. minute) within three hours after consumption of flax seed cake.
One day
Flax Seed Cake and Satiety Response Measurements
Ramy czasowe: One day
Measurement of the satiety response seven times (0. minute, 15. minute, 30. minute, 60. minute, 90. minute, 120. minute, 180. minute) within three hours after consumption of flax seed cake.
One day
Chia Cake and Blood Glucose Parameters
Ramy czasowe: One day
Measurement of blood glucose parameters seven times (0. minute, 15. minute, 30. minute, 60. minute, 90. minute, 120. minute, 180. minute) within three hours after consumption of chia cake.
One day
Chia Cake and Plasma Insulin Levels
Ramy czasowe: One day
Measurement of plasma insulin levels seven times (0. minute, 15. minute, 30. minute, 60. minute, 90. minute, 120. minute, 180. minute) within three hours after consumption of chia cake.
One day
Chia Cake and Satiety Response Measurements
Ramy czasowe: One day
Measurement of the satiety response seven times (0. minute, 15. minute, 30. minute, 60. minute, 90. minute, 120. minute, 180. minute) within three hours after consumption of chia cake.
One day
Flax Seed and Chia Cake and Blood Glucose Parameters
Ramy czasowe: One day
Measurement of blood glucose parameters seven times (0. minute, 15. minute, 30. minute, 60. minute, 90. minute, 120. minute, 180. minute) within three hours after consumption of flax seed and chia cake.
One day
Flax Seed and Chia Cake and Plasma Insulin Levels
Ramy czasowe: One day
Measurement of plasma insulin levels seven times (0. minute, 15. minute, 30. minute, 60. minute, 90. minute, 120. minute, 180. minute) within three hours after consumption of flax seed and chia cake.
One day
Flax Seed Cake and Satiety Response Measurements
Ramy czasowe: One day
Measurement of the satiety response seven times (0. minute, 15. minute, 30. minute, 60. minute, 90. minute, 120. minute, 180. minute) within three hours after consumption of flax seed and chia cake.
One day
Standart Cake and Blood Glucose Parameters
Ramy czasowe: One day
Measurement of blood glucose parameters seven times (0. minute, 15. minute, 30. minute, 60. minute, 90. minute, 120. minute, 180. minute) within three hours after consumption of standart cake.
One day
Standart Cake and Plasma Insulin Levels
Ramy czasowe: One day
Measurement of plasma insulin levels seven times (0. minute, 15. minute, 30. minute, 60. minute, 90. minute, 120. minute, 180. minute) within three hours after consumption of standart cake.
One day
Standart Cake and Satiety Response Measurements
Ramy czasowe: One day
Measurement of the satiety response seven times (0. minute, 15. minute, 30. minute, 60. minute, 90. minute, 120. minute, 180. minute) within three hours after consumption of standart cake.
One day

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Nutritional analysis of flax seed, chia, flax seed + chia cake and standart cakes
Ramy czasowe: Five days
The study is two-fold. In the preliminary study, the standard and test cakes (chia added cake, flax seed added cake, and chia+flax seed added cake) were developed and the amount of cake containing 50 g carbohydrate and the amount of moisture, ash, pulp, protein, fat, and digestible carbohydrate will be determined via analyses that will be carried at Toros University Food Chemistry Laboratory. Based on the results obtained, the amount of cakes containing 50 g digestible carbohydrate will be calculated and produced.
Five days

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

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)

1 maja 2022

Zakończenie podstawowe (Oczekiwany)

19 czerwca 2022

Ukończenie studiów (Oczekiwany)

1 września 2022

Daty rejestracji na studia

Pierwszy przesłany

22 kwietnia 2022

Pierwszy przesłany, który spełnia kryteria kontroli jakości

27 kwietnia 2022

Pierwszy wysłany (Rzeczywisty)

3 maja 2022

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

23 czerwca 2022

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

22 czerwca 2022

Ostatnia weryfikacja

1 czerwca 2022

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • ChiaFlaxseed

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

Data can be shared with permission of principal investigator

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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