- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT05358561
Postprandial Glucose, Insulin and Subjective Saturation Response in Healthy Individuals
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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Studientyp
Einschreibung (Voraussichtlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Özlem ÖZPAK AKKUŞ, PhD
- Telefonnummer: +905051397978
- E-Mail: dytozlemozpak@hotmail.com
Studienorte
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Mersin, Truthahn, 33040
- Rekrutierung
- Özlem ÖZPAK AKKUŞ
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Kontakt:
- Özlem ÖZPAK AKKUŞ
- Telefonnummer: 05051397978
- E-Mail: dytozlemozpak@hotmail.com
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Kein Eingriff: 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.
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Experimental: Flaxseed cake
Measuring blood glucose levels, plasma insulin and the satiety response levels of individuals after consumption of flaxseed cake
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Measuring blood glucose levels, plasma insulin and the satiety response levels of individuals after consumption of flaxseed, chia, flaxseed + chia and standart cakes
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Experimental: Chia cake
Measuring blood glucose levels, plasma insulin and the satiety response levels of individuals after consumption of chia cake
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Measuring blood glucose levels, plasma insulin and the satiety response levels of individuals after consumption of flaxseed, chia, flaxseed + chia and standart cakes
|
|
Experimental: Flaxseed and chia cake
Measuring blood glucose levels, plasma insulin and the satiety response levels of individuals after consumption of flaxseed and chia cake
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Measuring blood glucose levels, plasma insulin and the satiety response levels of individuals after consumption of flaxseed, chia, flaxseed + chia and standart cakes
|
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Experimental: Standart
Measuring blood glucose levels, plasma insulin and the satiety response levels of individuals after consumption of standart cake
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Measuring blood glucose levels, plasma insulin and the satiety response levels of individuals after consumption of flaxseed, chia, flaxseed + chia and standart cakes
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Flax Seed Cake and Blood Glucose Parameters
Zeitfenster: 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.
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One day
|
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Flax Seed Cake and Plasma Insulin Levels
Zeitfenster: 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.
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One day
|
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Flax Seed Cake and Satiety Response Measurements
Zeitfenster: 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.
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One day
|
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Chia Cake and Blood Glucose Parameters
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Nutritional analysis of flax seed, chia, flax seed + chia cake and standart cakes
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Voraussichtlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- ChiaFlaxseed
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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