- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Özlem ÖZPAK AKKUŞ, PhD
- Numéro de téléphone: +905051397978
- E-mail: dytozlemozpak@hotmail.com
Lieux d'étude
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Mersin, Turquie, 33040
- Recrutement
- Özlem ÖZPAK AKKUŞ
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Contact:
- Özlem ÖZPAK AKKUŞ
- Numéro de téléphone: 05051397978
- E-mail: dytozlemozpak@hotmail.com
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Non randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Aucune intervention: 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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|
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Expérimental: 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
|
|
Expérimental: 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
|
|
Expérimental: 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
|
|
Expérimental: 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
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Flax Seed Cake and Blood Glucose Parameters
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Nutritional analysis of flax seed, chia, flax seed + chia cake and standart cakes
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- ChiaFlaxseed
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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