- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Özlem ÖZPAK AKKUŞ, PhD
- Telefonnummer: +905051397978
- E-post: dytozlemozpak@hotmail.com
Studiesteder
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Mersin, Tyrkia, 33040
- Rekruttering
- Özlem ÖZPAK AKKUŞ
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Ta kontakt med:
- Özlem ÖZPAK AKKUŞ
- Telefonnummer: 05051397978
- E-post: dytozlemozpak@hotmail.com
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Ingen inngripen: 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.
|
|
Eksperimentell: 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
|
Eksperimentell: 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
|
Eksperimentell: 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
|
Eksperimentell: 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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Flax Seed Cake and Blood Glucose Parameters
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Nutritional analysis of flax seed, chia, flax seed + chia cake and standart cakes
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- ChiaFlaxseed
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Legemiddel- og utstyrsinformasjon, studiedokumenter
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