Effects of a Hemp Seed-based Product on Appetite and Health Parameters
Development of Products Containing Hemp Seeds and the Determination of Their Effects on Appetite Parameters, Body Composition, Sleep Quality, and Blood Parameters
This study aims to develop a snack containing hemp seeds and to investigate the potential effects of its consumption on appetite parameters, body composition, and blood markers in healthy participants. It is expected that this study will provide the scientific community with new, evidence-based, and comprehensive data regarding the potential use of hemp seeds in human nutrition and their role in clinical outcomes.
Tutkimuksen yleiskatsaus
Tila
Tila
Ehdot
Ehdot
Interventio / Hoito
Interventio / Hoito
Yksityiskohtainen kuvaus
The objective of this study is to evaluate the clinical effects of regular consumption of a newly developed hemp seed-based snack over a period of 8 weeks. The study consists of two sequential stages: product development and a clinical trial.
- Product Development: Development of five different grissini/cracker formulations with hemp seed content ranging from 0% to 25%, followed by the selection of the most preferred formulation based on sensory evaluation by a trained panel of 12 individuals. This panel will take place at the Haliç University Nutrition Principles Laboratory.
- Clinical Trial: A randomized, parallel-group, triple-blind, controlled clinical trial (lasting 8 weeks) involving 70 healthy participants aged 25-45. The clinical implementation stage of the study will be carried out at the SOCAR Istanbul.
Participants in the intervention group will consume the product formulation selected during the product development phase, while those in the control group will consume an isocaloric snack that does not contain hemp seeds. Both groups will receive general education regarding the Mediterranean-style dietary pattern.
Changes in body composition, appetite status, gastrointestinal symptoms, and sleep quality will be monitored every two weeks. Fasting blood samples will be analyzed at the beginning of the study (week 0) and after the intervention (week 8) to assess lipid profiles, glycemic control, and markers of liver function.
Opintotyyppi
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Ilmoittautuminen
Vaihe
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskeluyhteys
Opiskeluyhteys
- Nimi: Beste Eker, PhD Candidate
- Puhelinnumero: +90 530 528 84 20
- Sähköposti: 23151010815@halic.edu.tr
Tutki yhteystietojen varmuuskopiointi
- Nimi: Ahmet M Gunal, Assoc. Prof. Dr.
- Puhelinnumero: +90 505 240 60 49
- Sähköposti: ahmetgunal@halic.edu.tr
Opiskelupaikat
-
-
-
Istanbul, Turkki (Türkiye)
- Rekrytointi
- SOCAR Istanbul
-
Ottaa yhteyttä:
- Canan Aksoy, Dietitian
- Puhelinnumero: +90 532 573 41 72
- Sähköposti: canan.aksoy-ext@socar.com.tr
-
Ottaa yhteyttä:
- Beste Eker, PhD candidate
- Puhelinnumero: +90 530 528 84 20
- Sähköposti: 23151010815@halic.edu.tr
-
Alatutkija:
- Beste Eker, PhD candidate
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
Inclusion Criteria:
-
Healthy male or female individuals aged 25 to 45 years.
-
Body Mass Index (BMI) within the following categories:
- Normal weight (BMI: 18.5 - 24.9 kg/m²)
- Overweight (BMI: 25.0 - 29.9 kg/m²)
- Obese (BMI >= 30.0 kg/m²)
-
Free of any diagnosed chronic diseases or metabolic disorders.
-
Demonstrating good compliance with product consumption protocols and study timelines.
-
Voluntarily signing the Informed Consent Form.
Exclusion Criteria:
- Known food allergies or intolerances, particularly to hempseed, other seeds, or oily nuts.
- History of significant gastrointestinal diseases or recurrent severe digestive complaints.
- Current pregnancy or lactation.
- Following a vegan or vegetarian diet (to ensure baseline dietary standardization).
- Experiencing new health problems during the intervention that could affect the study outcomes.
- Unwillingness or inability to comply with product consumption and data collection procedures.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Perustiede
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Kolminkertaistaa
Aseiden lukumäärä
Aseet ja interventiot
Osallistujaryhmä / ArmOsallistujaryhmä / Arm |
Interventio / HoitoInterventio / Hoito |
|---|---|
|
Kokeellinen: Hempseed Snack Group
Participants in this arm will consume a standardized daily functional snack (grissini/cracker) containing hempseed for 8 weeks. Both groups will also receive general nutritional education on the Mediterranean diet model. |
A specially formulated grissini/cracker snack containing hemp seeds. Participants will consume this snack daily for 8 weeks to evaluate its effects on metabolic and physiological parameters, thereby ingesting a specific amount of hemp seeds (the exact quantity to be determined based on the panel results). |
|
Placebo Comparator: Control Snack Group
Participants in this arm will consume a control snack (grissini/cracker) with 0% hempseed for 8 weeks. The snack matches the intervention product in appearance, weight, taste, and texture. Both groups will also receive general nutritional education on the Mediterranean diet model. |
A control grissini/cracker snack containing 0% hemp seeds will be developed. To maintain a triple-blind protocol, this snack will be designed to be identical to the experimental snack in terms of appearance, weight, flavor, and texture. The snack in question will be consumed daily for a period of 8 weeks. |
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Change from Baseline in Hunger Score
Aikaikkuna: Baseline (Week 0), Week 2, Week 4, Week 6, and Week 8.
|
Hunger will be assessed using a 100-mm (10 cm) Visual Analog Scale (VAS), ranging from 0 to 100 mm (10 cm). Higher scores indicate greater subjective hunger. Hunger: 0 = Not hungry at all, 100 = Extremely hungry. |
Baseline (Week 0), Week 2, Week 4, Week 6, and Week 8.
|
|
Change from Baseline in Fullness Score
Aikaikkuna: Baseline (Week 0), Week 2, Week 4, Week 6, and Week 8.
|
Subjective fullness will be assessed using a 100-mm (10 cm) Visual Analog Scale (VAS), ranging from 0 to 100 mm (10 cm). Higher scores indicate greater subjective fullness. Fullness: 0 = Not full at all, 100 = Extremely full. |
Baseline (Week 0), Week 2, Week 4, Week 6, and Week 8.
|
|
Change from Baseline in Desire to Eat Score
Aikaikkuna: Baseline (Week 0), Week 2, Week 4, Week 6, and Week 8.
|
Desire to eat will be assessed using a 100-mm (10 cm) Visual Analog Scale (VAS), ranging from 0 to 100 mm (10 cm). Higher scores indicate a greater desire to eat. Desire to Eat: 0 = No desire to eat, 100 = Extremely strong desire to eat. |
Baseline (Week 0), Week 2, Week 4, Week 6, and Week 8.
|
Toissijaiset tulostoimenpiteet
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Change from Baseline in Body Weight
Aikaikkuna: Baseline (Week 0), Week 2, Week 4, Week 6, and Week 8.
|
Body weight will be measured in kilograms (kg) using the Tanita BC-418 body composition analyzer. Changes in body weight from baseline throughout the intervention will be evaluated. |
Baseline (Week 0), Week 2, Week 4, Week 6, and Week 8.
|
|
Change from Baseline in Body Mass Index (BMI)
Aikaikkuna: Baseline (Week 0), Week 2, Week 4, Week 6, and Week 8.
|
Body mass index (BMI) will be calculated using body weight measured with the Tanita BC-418 body composition analyzer and height measured using a stadiometer. BMI will be calculated as body weight in kilograms divided by height in meters squared (kg/m²). Changes in BMI from baseline throughout the intervention will be evaluated. |
Baseline (Week 0), Week 2, Week 4, Week 6, and Week 8.
|
|
Change from Baseline in Body Fat Percentage
Aikaikkuna: Baseline (Week 0), Week 2, Week 4, Week 6, and Week 8.
|
Body fat percentage will be assessed using bioelectrical impedance analysis (BIA) with the Tanita BC-418 body composition analyzer and expressed as a percentage (%). Changes in body fat percentage from baseline throughout the intervention will be evaluated. |
Baseline (Week 0), Week 2, Week 4, Week 6, and Week 8.
|
|
Change from Baseline in Fat Mass
Aikaikkuna: Baseline (Week 0), Week 2, Week 4, Week 6, and Week 8.
|
Fat mass will be assessed using bioelectrical impedance analysis (BIA) with the Tanita BC-418 body composition analyzer and expressed in kilograms (kg). Changes in fat mass from baseline throughout the intervention will be evaluated. |
Baseline (Week 0), Week 2, Week 4, Week 6, and Week 8.
|
|
Change from Baseline in Fat-Free Mass
Aikaikkuna: Baseline (Week 0), Week 2, Week 4, Week 6, and Week 8.
|
Fat-free mass (FFM) will be assessed using bioelectrical impedance analysis (BIA) with the Tanita BC-418 body composition analyzer and expressed in kilograms (kg). Fat-free mass represents total body mass excluding fat mass. Changes in fat-free mass from baseline throughout the intervention will be evaluated. |
Baseline (Week 0), Week 2, Week 4, Week 6, and Week 8.
|
|
Change from Baseline in Gastrointestinal Symptom Rating Scale Score
Aikaikkuna: Baseline (Week 0), Week 4, and Week 8.
|
Gastrointestinal symptoms will be assessed using the Turkish-adapted and validated version of the Gastrointestinal Symptom Rating Scale (GSRS) (Turan et al., 2017). The scale consists of 15 items rated on a 7-point Likert scale (1-7), covering five symptom domains: abdominal pain, reflux, indigestion, diarrhea, and constipation. Higher scores indicate more severe gastrointestinal symptoms. Total and/or domain scores will be evaluated according to the scale scoring guidelines. |
Baseline (Week 0), Week 4, and Week 8.
|
|
Change from Baseline in Pittsburgh Sleep Quality Index Score
Aikaikkuna: Baseline (Week 0), Week 2, Week 4, Week 6, and Week 8.
|
Sleep quality will be assessed using the Turkish-adapted and validated version of the Pittsburgh Sleep Quality Index (PSQI) (Ağargün et al., 1996). The questionnaire consists of 10 main questions and evaluates seven components of sleep quality. Each component is scored from 0 to 3, yielding a global score ranging from 0 to 21. Higher scores indicate poorer sleep quality, and scores greater than 5 indicate poor sleep quality. |
Baseline (Week 0), Week 2, Week 4, Week 6, and Week 8.
|
|
Change from Baseline in Total Cholesterol Levels
Aikaikkuna: Baseline (Week 0) and Week 8.
|
Total cholesterol levels will be measured in fasting venous blood samples and expressed in milligrams per deciliter (mg/dL). Changes in total cholesterol levels from baseline to the end of the intervention will be evaluated. |
Baseline (Week 0) and Week 8.
|
|
Change from Baseline in LDL Cholesterol Levels
Aikaikkuna: Baseline (Week 0) and Week 8.
|
Low-density lipoprotein cholesterol (LDL-C) levels will be measured in fasting venous blood samples and expressed in milligrams per deciliter (mg/dL). Changes in LDL-C levels from baseline to the end of the intervention will be evaluated. Higher levels generally indicate a less favorable lipid profile. |
Baseline (Week 0) and Week 8.
|
|
Change from Baseline in HDL Cholesterol Levels
Aikaikkuna: Baseline (Week 0) and Week 8.
|
High-density lipoprotein cholesterol (HDL-C) levels will be measured in fasting venous blood samples and expressed in milligrams per deciliter (mg/dL). Changes in HDL-C levels from baseline to the end of the intervention will be evaluated. Higher levels generally indicate a more favorable lipid profile. |
Baseline (Week 0) and Week 8.
|
|
Change from Baseline in Triglyceride Levels
Aikaikkuna: Baseline (Week 0) and Week 8.
|
Triglyceride levels will be measured in fasting venous blood samples and expressed in milligrams per deciliter (mg/dL). Changes in triglyceride levels from baseline to the end of the intervention will be evaluated. Higher levels indicate an unfavorable lipid profile. |
Baseline (Week 0) and Week 8.
|
|
Change from Baseline in Fasting Blood Glucose Levels
Aikaikkuna: Baseline (Week 0) and Week 8.
|
Fasting blood glucose levels will be measured in venous blood samples after at least 8 hours of fasting and expressed in milligrams per deciliter (mg/dL). Changes in fasting blood glucose levels from baseline to the end of the intervention will be evaluated. |
Baseline (Week 0) and Week 8.
|
|
Change from Baseline in Fasting Insulin Levels
Aikaikkuna: Baseline (Week 0) and Week 8.
|
Fasting insulin levels will be measured in venous blood samples after at least 8 hours of fasting and expressed in microinternational units per milliliter (μIU/mL). Changes in fasting insulin levels from baseline to the end of the intervention will be evaluated. |
Baseline (Week 0) and Week 8.
|
|
Change from Baseline in Glycated Hemoglobin (HbA1c) Levels
Aikaikkuna: Baseline (Week 0) and Week 8.
|
Glycated hemoglobin (HbA1c) levels will be measured in venous blood samples and expressed as a percentage (%). HbA1c reflects average blood glucose levels over approximately the previous 2-3 months. Changes in HbA1c levels from baseline to the end of the intervention will be evaluated. |
Baseline (Week 0) and Week 8.
|
|
Change from Baseline in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Aikaikkuna: Baseline (Week 0) and Week 8.
|
Insulin resistance will be assessed using the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR), calculated using fasting insulin (μIU/mL) and fasting blood glucose (mg/dL) concentrations. HOMA-IR will be calculated as fasting insulin multiplied by fasting blood glucose divided by 405. Higher HOMA-IR values indicate greater insulin resistance. |
Baseline (Week 0) and Week 8.
|
|
Change from Baseline in Alanine Aminotransferase (ALT) Levels
Aikaikkuna: Baseline (Week 0) and Week 8.
|
Alanine aminotransferase (ALT) levels will be measured in venous blood samples and expressed in units per liter (U/L). Changes in ALT levels from baseline to the end of the intervention will be evaluated. Elevated ALT levels may indicate hepatocellular injury. |
Baseline (Week 0) and Week 8.
|
|
Change from Baseline in Aspartate Aminotransferase (AST) Levels
Aikaikkuna: Baseline (Week 0) and Week 8.
|
Aspartate aminotransferase (AST) levels will be measured in venous blood samples and expressed in units per liter (U/L). Changes in AST levels from baseline to the end of the intervention will be evaluated. Elevated AST levels may indicate tissue injury, including liver or muscle injury. |
Baseline (Week 0) and Week 8.
|
Yhteistyökumppanit ja tutkijat
Sponsori
Sponsori
Tutkijat
Tutkijat
- Päätutkija: Ahmet M Gunal, Assoc. Prof. Dr., Halic University and SOCAR İstanbul
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Opiskelun aloitus
Ensisijainen valmistuminen (Arvioitu)
Ensisijainen valmistuminen
Opintojen valmistuminen (Arvioitu)
Opintojen valmistuminen
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Ensimmäinen Lähetetty
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin päivitys julkaistu
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muut tutkimustunnusnumerot
Muut tutkimustunnusnumerot
- 2026-12/145
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
to protect participant confidentiality and ensure institutional data security guidelines, individual participant data will not be shared. The scientific findings will be thoroughly disclosed through the finalized doctoral thesis and peer-reviewed journal publications.
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .