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

2026年11月2日 更新者: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.

研究概览

地位

招聘中

条件

详细说明

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.

研究类型

介入性

注册 (估计的)

70

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

25年 至 45年 (成人)

接受健康志愿者

是的

有资格学习的性别

全部

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:基础科学
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:三倍

武器和干预

参与者组/臂
干预/治疗
实验性的: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).

安慰剂比较: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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change from Baseline in Hunger Score
大体时间: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
大体时间: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
大体时间: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.

次要结果测量

结果测量
措施说明
大体时间
Change from Baseline in Body Weight
大体时间: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)
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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)
大体时间: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
大体时间: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
大体时间: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.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Ahmet M Gunal, Assoc. Prof. Dr.、Halic University and SOCAR İstanbul

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年11月2日

初级完成 (估计的)

2027年3月25日

研究完成 (估计的)

2027年3月25日

研究注册日期

首次提交

2026年10月18日

首先提交符合 QC 标准的

2026年11月2日

首次发布 (实际的)

2026年11月4日

研究记录更新

最后更新发布 (实际的)

2026年11月4日

上次提交的符合 QC 标准的更新

2026年11月2日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

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.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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