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

2 november 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

70

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

25 jaar tot 45 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Fundamentele wetenschap
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verdrievoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Ander: 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).
Placebo-vergelijker: 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.
Ander: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change from Baseline in Hunger Score
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change from Baseline in Body Weight
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Halic University

Onderzoekers

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

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

2 november 2026

Primaire voltooiing (Geschat)

25 maart 2027

Studie voltooiing (Geschat)

25 maart 2027

Studieregistratiedata

Eerst ingediend

18 oktober 2026

Eerst ingediend dat voldeed aan de QC-criteria

2 november 2026

Eerst geplaatst (Werkelijk)

4 november 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

4 november 2026

Laatste update ingediend die voldeed aan QC-criteria

2 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • 2026-12/145

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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