Type 2 Diabetes MellitusNCT06826235
Investigation of the Effect of Date Consumption on Hedonic Hunger and Appetite in Adult Individuals With Type 2 Diabetes
A study testing 3 dates at the breakfast meal in the diet program in people with Type 2 Diabetes Mellitus and Appetite, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to investigate the effects of date consumption on hedonic hunger and appetite hormones in individuals diagnosed with type 2 diabetes.The main questions it aims to answer are: Does date consumption reduce hedonic hunger in individuals with type 2 diabetes? Does persimmon consumption change… Read more about this study
- Who is it for?
- Ages 19 to 50 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Appetite
- What is being tested?
- 3 dates at the breakfast meal in the diet program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 May 2024to 1 Mar 2025
- 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 19 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Individuals diagnosed with Type 2 diabetes aged 19-50 years (excluding menopausal women),
- Individuals with BMI between 25-35 kg/m2,
- Individuals with a Nutritional Strength Scale score of 2.5 and above,
- Individuals who agreed not to start taking new dietary supplements or alternative therapies during the study period,
- Individuals who agree not to change their current physical activity level and diet.
Who cannot join
- Individuals who do not approve the volunteer consent form,
- Individuals with a Nutritional Strength Scale score below 2.5,
- Pregnant or breastfeeding women (or women planning to become pregnant within 3 months)
- Individuals with dietary energy <800 kcal/day and >4000 kcal/day,
- Individuals with pre-diabetes, type 1 diabetes and gestational diabetes,
- Individuals with HbA1c >10
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- Individuals taking antibiotics or hormone replacement therapy History of malignancy (except non-melanoma skin cancer).
- Individuals with regular consumption of dates before inclusion in the study,
- Individuals diagnosed with Type 2 diabetes using insulin and oral antidiabetic drugs with thiazolidinedione active substance,
- Individuals with a history of diabetic ketoacidosis, diabetic coma or precoma within 6 months prior to the date of admission; serious infections, surgery, serious trauma requiring insulin treatment, haemodialysis treatment (including peritoneal haemodialysis), serious liver injury and serious vascular complications (stroke, myocardial infarction and heart failure) requiring hospitalisation,
- Individuals taking pharmacological agents that have effects on appetite such as psychotropics, antiepileptics, antidepressants, antipsychotics and/or steroids,
- Individuals diagnosed with eating disorders and/or psychological disorders,
- Individuals with physical illnesses that affect eating behaviour or appetite, such as uncontrolled hyperthyroidism or hypothyroidism, Cushing's disease, acromegaly, adrenal insufficiency, chronic renal failure (stage 4 or 5), tuberculosis, human immunodeficiency virus (HIV) infection.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Erzurum City Hospital
Erzurum, Palandöken, 25070
MURAT F VURAL, +905412147425, aysecamli19966@gmail.com
About this study
Official title: Tip 2 Diyabetli Yetişkin Bireylerde Hurma Tüketiminin Hedonik Açlık ve İştah Hormonları Üzerine Etkilerinin İncelenmesi
The aim of this study was to investigate the effects of date consumption on hedonic hunger and appetite hormones in individuals diagnosed with type 2 diabetes.The main questions it aims to answer are:
- Does date consumption reduce hedonic hunger in individuals with type 2 diabetes?
- Does persimmon consumption change Ghrelin, GLP-1 and GIP concentrations in individuals with Type 2 diabetes?
- Does persimmon consumption reduce HOMA-IR and HbA1c values in individuals with Type 2 diabetes?
- Does consumption of persimmon reduce LDL cholesterol, total cholesterol and triglyceride concentrations in individuals with type 2 diabetes? To see the effects of date consumption on hedonic hunger and appetite hormones, the researchers will compare individuals with type 2 diabetes who consume 3 dates daily with individuals with type 2 diabetes who do not.
Read more
Participants:
- Individuals in the intervention group will consume 3 (25 g) Baghdad dates (15 g CHO) daily as part of the breakfast meal, while individuals in the control group will not consume dates.
- Three interviews will be conducted with patients.
- A record of blood findings and questionnaires will be kept during these interviews.
Read the detailed description
- Study Design and Participants The sample of this randomised controlled clinical trial will consist of adult individuals with Type 2 diabetes who apply to Erzurum City Hospital Internal Medicine outpatient clinic. A control group will be formed with individuals with Type 2 diabetes in the same age group. Informed Voluntary Consent Form will be obtained from the individuals before starting the study. Power analysis was performed to determine the sample size. The study population was determined as 70 individuals with the G-power programme. In this randomised controlled study, individuals will be randomly assigned to the intervention and control groups using a computer generated list.
- Intervention and Control Groups Individuals who agree to participate in the study will be randomly assigned to the intervention and control groups. The study consists of three stages. The first interview will take place at week 0, the second interview at week 6 and the last interview at week 12. The control group will not be intervened by not giving any additional food and will be asked not to consume dates during the study. The intervention group will be informed at the first interview about which meal and in what quantity they will consume dates. Dates will be delivered to participants at baseline (6-week supply) and at week 6 of the study (6-week supply). Individuals in the intervention group will consume 3 (25 g) Baghdad dates (15 g CHO) daily as part of the breakfast meal. Individuals will be given weekly recording sheets to record their date consumption. The diaries will be collected fortnightly to ensure dates are consumed as directed (a photo of the diary will be requested via email or social media). Individuals will receive a fortnightly telephone reminder.
- Questionnaire Form Information such as socio-demographic characteristics, smoking and alcohol consumption status, health status, medication used in diabetes treatment, etc. will be obtained through a face-to-face questionnaire. Visual Analogue Scale (VAS) will be used for subjective hunger. The questionnaire form will also include the Food Power Scale for the assessment of hedonic hunger, the International Physical Activity Questionnaire short form (IPAQ-SF) for the assessment of physical activity levels and three-day Food Consumption Records for the assessment of food consumption.
- Anthropometric Measurements In the study, anthropometric measurements of individuals will be taken at 0. 6. and 12. weeks. Height will be measured with a stadiometer (SECA 213) with an accuracy of 0.1 cm with the feet side by side and the head in the Frankort plane. Bioelectrical impedance analysis (BIA) (TanitaBC-730) will be used to evaluate body weight and body composition. The measurements will be performed by the researcher.
- Biochemical analyses Blood samples taken from the individuals at weeks 0 and 12 will be analysed in the Biochemistry Laboratory of Atatürk University Research Hospital. Fasting blood glucose, fasting blood insulin, HbA1c, Ghrelin, GLP-1, GIP total cholesterol, LDL cholesterol and triglyceride analyses will be performed. Fasting blood glucose, fasting blood insulin, HbA1c, total cholesterol, LDL cholesterol and triglycerides are the tests routinely requested by the doctor. Blood samples for ghrelin, GLP-1 and GIP analyses will be collected and analysed separately in the laboratory. Fasting blood glucose and insulin values of individuals who will be used in homeostatic model assessment for insulin resistance (HOMA-IR) will be measured. Fasting and postprandial blood glucose will be measured with a glucometer at 0, 6 and 12 weeks of the study.
- Statistical analyses will be performed using SPSS version 22 software.
- Conditions
- Type 2 Diabetes Mellitus, Appetite
- Being tested
- 3 dates at the breakfast meal in the diet program
- Keywords
- date, hedonic hunger, appetite, type 2 diabetes, lipid profile
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3 dates at the breakfast meal in the diet programOther
Participants in the intervention group will consume 3 dates at the breakfast meal in the diet program.
| Study group | Role | What they receive |
|---|---|---|
| INTERVENTION GROUP | Experimental | Not described Receives: Other: 3 dates at the breakfast meal in the diet program |
| CONTROL GROUP | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appetite hormone levels
GLP-1, GIP and Ghrelin hormone levels in plasma will be measured in pg/ml.
Measured: 3 months
Hedonic hunger levels
Hedonic hunger levels of individuals will be determined using the Power of Food Scale (PFS).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study start14 May 2024
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- control and intervention group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AYŞE ÇAMLİ, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06826235
- Sponsor's protocol ID
- 06.03.2024-26185
- Status last verified
- Feb 2025
- First submitted
- 23 Jan 2025
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tip 2 Diyabetli Yetişkin Bireylerde Hurma Tüketiminin Hedonik Açlık ve İştah Hormonları Üzerine Etkilerinin İncelenmesi
- ClinicalTrials.gov ID
- NCT06826235
- Acronym / sponsor ID
- 06.03.2024-26185
- Conditions
- Type 2 Diabetes Mellitus, Appetite
- Keywords
- date, hedonic hunger, appetite, type 2 diabetes, lipid profile
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 14 May 2024 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 13 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study was to investigate the effects of date consumption on hedonic hunger and appetite hormones in individuals diagnosed with type 2 diabetes.The main questions it aims to answer are:
- Does date consumption reduce hedonic hunger in individuals with type 2 diabetes?
- Does persimmon consumption change Ghrelin, GLP-1 and GIP concentrations in individuals with Type 2 diabetes?
- Does persimmon consumption reduce HOMA-IR and HbA1c values in individuals with Type 2 diabetes?
- Does consumption of persimmon reduce LDL cholesterol, total cholesterol and triglyceride concentrations in individuals with type 2 diabetes? To see the effects of date consumption on hedonic hunger and appetite hormones, the researchers will compare individuals with type 2 diabetes who consume 3 dates daily with individuals with type 2 diabetes who do not.
Participants:
- Individuals in the intervention group will consume 3 (25 g) Baghdad dates (15 g CHO) daily as part of the breakfast meal, while individuals in the control group will not consume dates.
- Three interviews will be conducted with patients.
- A record of blood findings and questionnaires will be kept during these interviews.
Detailed description
- Study Design and Participants The sample of this randomised controlled clinical trial will consist of adult individuals with Type 2 diabetes who apply to Erzurum City Hospital Internal Medicine outpatient clinic. A control group will be formed with individuals with Type 2 diabetes in the same age group. Informed Voluntary Consent Form will be obtained from the individuals before starting the study. Power analysis was performed to determine the sample size. The study population was determined as 70 individuals with the G-power programme. In this randomised controlled study, individuals will be randomly assigned to the intervention and control groups using a computer generated list.
- Intervention and Control Groups Individuals who agree to participate in the study will be randomly assigned to the intervention and control groups. The study consists of three stages. The first interview will take place at week 0, the second interview at week 6 and the last interview at week 12. The control group will not be intervened by not giving any additional food and will be asked not to consume dates during the study. The intervention group will be informed at the first interview about which meal and in what quantity they will consume dates. Dates will be delivered to participants at baseline (6-week supply) and at week 6 of the study (6-week supply). Individuals in the intervention group will consume 3 (25 g) Baghdad dates (15 g CHO) daily as part of the breakfast meal. Individuals will be given weekly recording sheets to record their date consumption. The diaries will be collected fortnightly to ensure dates are consumed as directed (a photo of the diary will be requested via email or social media). Individuals will receive a fortnightly telephone reminder.
- Questionnaire Form Information such as socio-demographic characteristics, smoking and alcohol consumption status, health status, medication used in diabetes treatment, etc. will be obtained through a face-to-face questionnaire. Visual Analogue Scale (VAS) will be used for subjective hunger. The questionnaire form will also include the Food Power Scale for the assessment of hedonic hunger, the International Physical Activity Questionnaire short form (IPAQ-SF) for the assessment of physical activity levels and three-day Food Consumption Records for the assessment of food consumption.
- Anthropometric Measurements In the study, anthropometric measurements of individuals will be taken at 0. 6. and 12. weeks. Height will be measured with a stadiometer (SECA 213) with an accuracy of 0.1 cm with the feet side by side and the head in the Frankort plane. Bioelectrical impedance analysis (BIA) (TanitaBC-730) will be used to evaluate body weight and body composition. The measurements will be performed by the researcher.
- Biochemical analyses Blood samples taken from the individuals at weeks 0 and 12 will be analysed in the Biochemistry Laboratory of Atatürk University Research Hospital. Fasting blood glucose, fasting blood insulin, HbA1c, Ghrelin, GLP-1, GIP total cholesterol, LDL cholesterol and triglyceride analyses will be performed. Fasting blood glucose, fasting blood insulin, HbA1c, total cholesterol, LDL cholesterol and triglycerides are the tests routinely requested by the doctor. Blood samples for ghrelin, GLP-1 and GIP analyses will be collected and analysed separately in the laboratory. Fasting blood glucose and insulin values of individuals who will be used in homeostatic model assessment for insulin resistance (HOMA-IR) will be measured. Fasting and postprandial blood glucose will be measured with a glucometer at 0, 6 and 12 weeks of the study.
- Statistical analyses will be performed using SPSS version 22 software.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- control and intervention group
| Arm | Type | Receives |
|---|---|---|
| INTERVENTION GROUP | Experimental | Other: 3 dates at the breakfast meal in the diet program |
| CONTROL GROUP | No intervention | – |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Individuals diagnosed with Type 2 diabetes aged 19-50 years (excluding menopausal women),
- Individuals with BMI between 25-35 kg/m2,
- Individuals with a Nutritional Strength Scale score of 2.5 and above,
- Individuals who agreed not to start taking new dietary supplements or alternative therapies during the study period,
- Individuals who agree not to change their current physical activity level and diet.
Key exclusion criteria (13 listed)
- Individuals who do not approve the volunteer consent form,
- Individuals with a Nutritional Strength Scale score below 2.5,
- Pregnant or breastfeeding women (or women planning to become pregnant within 3 months)
- Individuals with dietary energy <800 kcal/day and >4000 kcal/day,
- Individuals with pre-diabetes, type 1 diabetes and gestational diabetes,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3 dates at the breakfast meal in the diet programParticipants in the intervention group will consume 3 dates at the breakfast meal in the diet program. | Other | INTERVENTION GROUP |
Primary outcome
Appetite hormone levels
Time frame: 3 months
GLP-1, GIP and Ghrelin hormone levels in plasma will be measured in pg/ml.
Hedonic hunger levels
Time frame: 3 months
Hedonic hunger levels of individuals will be determined using the Power of Food Scale (PFS).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3 dates at the breakfast meal in the diet program in people with Type 2 Diabetes Mellitus and Appetite, run by Hacettepe 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 5 inclusion and 13 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 13 Feb 2025. 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. 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 AYŞE ÇAMLİ (+905364254169, aysecamli1996@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Appetite hormone levels (time frame: 3 months). The study lists 2 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 13 Feb 2025.