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HealthyNCT07917130

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

A study testing hempseed snack in people with Healthy, run by Halic University at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 25 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
hempseed snack
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
70 participants
Where
1 siteTurkey (Türkiye)
Study dates
2 Nov 2026to 25 Mar 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Beste Eker, PhD Candidate contact

+90 530 528 84 20

23151010815@halic.edu.tr

Ahmet M Gunal, Assoc. Prof. Dr. contact

+90 505 240 60 49

ahmetgunal@halic.edu.tr

Turkey (Türkiye)1 site, 1 recruiting
  • SOCAR Istanbul

    Istanbul

    Canan Aksoy, Dietitian, +90 532 573 41 72, canan.aksoy-ext@socar.com.tr

    Beste Eker, PhD candidate, +90 530 528 84 20, 23151010815@halic.edu.tr

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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.

Conditions
Healthy
Being tested
hempseed snack, control snack
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

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • hempseed snackOther

    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).

  • control snackOther

    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.

Study groups in NCT07917130
Study groupRoleWhat they receive
Hempseed Snack GroupExperimentalParticipants 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.
Receives: Other: hempseed snack
Control Snack GroupPlacebo comparatorParticipants 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.
Receives: Other: control snack

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline (Week 0), Week 2, Week 4, Week 6, and Week 8.

  2. 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.

    Measured: Baseline (Week 0), Week 2, Week 4, Week 6, and Week 8.

  3. 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.

    Measured: Baseline (Week 0), Week 2, Week 4, Week 6, and Week 8.

Secondary outcomes (17)
  1. 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.

    Measured: Baseline (Week 0), Week 2, Week 4, Week 6, and Week 8.

  2. 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.

    Measured: Baseline (Week 0), Week 2, Week 4, Week 6, and Week 8.

  3. 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.

    Measured: Baseline (Week 0), Week 2, Week 4, Week 6, and Week 8.

  4. 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.

    Measured: Baseline (Week 0), Week 2, Week 4, Week 6, and Week 8.

  5. 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.

    Measured: Baseline (Week 0), Week 2, Week 4, Week 6, and Week 8.

  6. 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.

    Measured: Baseline (Week 0), Week 4, and Week 8.

  7. 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.

    Measured: Baseline (Week 0), Week 2, Week 4, Week 6, and Week 8.

  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.

    Measured: Baseline (Week 0) and Week 8.

  9. 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.

    Measured: Baseline (Week 0) and Week 8.

  10. 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.

    Measured: Baseline (Week 0) and Week 8.

  11. 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.

    Measured: Baseline (Week 0) and Week 8.

  12. 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.

    Measured: Baseline (Week 0) and Week 8.

  13. 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.

    Measured: Baseline (Week 0) and Week 8.

  14. 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.

    Measured: Baseline (Week 0) and Week 8.

  15. 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.

    Measured: Baseline (Week 0) and Week 8.

  16. 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.

    Measured: Baseline (Week 0) and Week 8.

  17. 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.

    Measured: Baseline (Week 0) and Week 8.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2026
  2. Study start2 Nov 2026 (estimated)
  3. Primary completion25 Mar 2027 (estimated)
  4. Study completion25 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Model description
a randomized, controlled, parallel-group, triple-blind intervention study consisting of intervention and control groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07917130
Sponsor's protocol ID
2026-12/145
Status last verified
Nov 2026
First submitted
18 Oct 2026
Last updated
4 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Questions about this trial

What is this clinical trial studying?

A study testing hempseed snack in people with Healthy, run by Halic University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Beste Eker, PhD Candidate (+90 530 528 84 20, 23151010815@halic.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in Hunger Score (time frame: Baseline (Week 0), Week 2, Week 4, Week 6, and Week 8.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.

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