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.

Study Overview

• Status: Recruiting
• Conditions: Healthy
• Intervention / Treatment: Other: hempseed snack; Other: control snack

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Beste Eker, PhD Candidate; Phone Number: +90 530 528 84 20; Email: 23151010815@halic.edu.tr
• Study Contact Backup: Name: Ahmet M Gunal, Assoc. Prof. Dr.; Phone Number: +90 505 240 60 49; Email: ahmetgunal@halic.edu.tr

Study Locations

• Turkey (Türkiye)
  • Istanbul, Turkey (Türkiye)
    • Recruiting
    • SOCAR Istanbul
    • Contact: Canan Aksoy, Dietitian; Phone Number: +90 532 573 41 72; Email: canan.aksoy-ext@socar.com.tr
    • Contact: Beste Eker, PhD candidate; Phone Number: +90 530 528 84 20; Email: 23151010815@halic.edu.tr
    • Sub-Investigator: Beste Eker, PhD candidate

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Hunger Score	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	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	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Body Weight	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)	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	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	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	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	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	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	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	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	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	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	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	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	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)	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	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	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.

Collaborators and Investigators

• Sponsor: Halic University
• Investigators: Principal Investigator: Ahmet M Gunal, Assoc. Prof. Dr., Halic University and SOCAR İstanbul

Study record dates

Study Major Dates

• Study Start (Estimated): November 2, 2026
• Primary Completion (Estimated): March 25, 2027
• Study Completion (Estimated): March 25, 2027

Study Registration Dates

• First Submitted: October 18, 2026
• First Submitted That Met QC Criteria: November 2, 2026
• First Posted (Actual): November 4, 2026

Study Record Updates

• Last Update Posted (Actual): November 4, 2026
• Last Update Submitted That Met QC Criteria: November 2, 2026
• Last Verified: November 1, 2026

More Information

Terms related to this study

• Keywords: hemp seed; hemp seed snack; hemp seed consumption and health; body composition and hemp seed; blood parameters and hemp seed consumption; health effects of hemp seed consumption
• Other Study ID Numbers: 2026-12/145

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No