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Effects of a Hemp Seed-based Product on Appetite and Health Parameters

2 listopada 2026 zaktualizowane przez: Beste EKER, Halic University

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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

  1. 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.
  2. 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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

70

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

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

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

25 lat do 45 lat (Dorosły)

Akceptuje zdrowych ochotników

Tak

Płeć kwalifikująca się do nauki

Wszystko

Opis

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.

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: Podstawowa nauka
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Potroić

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Inny: hempseed snack

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).
Komparator placebo: 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.
Inny: control snack

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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change from Baseline in Hunger Score
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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.

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change from Baseline in Body Weight
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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.

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Halic University

Śledczy

  • Główny śledczy: Ahmet M Gunal, Assoc. Prof. Dr., Halic University and SOCAR İstanbul

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 (Szacowany)

2 listopada 2026

Zakończenie podstawowe (Szacowany)

25 marca 2027

Ukończenie studiów (Szacowany)

25 marca 2027

Daty rejestracji na studia

Pierwszy przesłany

18 października 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

2 listopada 2026

Pierwszy wysłany (Rzeczywisty)

4 listopada 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

4 listopada 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

2 listopada 2026

Ostatnia weryfikacja

1 listopada 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Inne numery identyfikacyjne badania

  • 2026-12/145

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

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.

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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