Investigation of the Effect of Date Consumption on Hedonic Hunger and Appetite in Adult Individuals With Type 2 Diabetes
NCT ID: NCT06826235
Last Updated: 2025-02-13
Study Results
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Basic Information
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RECRUITING
NA
64 participants
INTERVENTIONAL
2024-05-14
2025-03-01
Brief Summary
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* 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.
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Detailed Description
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2. 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.
3. 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.
4. 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.
5. 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
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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INTERVENTION GROUP
3 dates at the breakfast meal in the diet program
Participants in the intervention group will consume 3 dates at the breakfast meal in the diet program.
CONTROL GROUP
No interventions assigned to this group
Interventions
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3 dates at the breakfast meal in the diet program
Participants in the intervention group will consume 3 dates at the breakfast meal in the diet program.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
* 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.
19 Years
50 Years
ALL
No
Sponsors
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Hacettepe University
OTHER
Responsible Party
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AYŞE ÇAMLİ
Research Assistant
Locations
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Erzurum City Hospital
Erzurum, Palandöken, Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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06.03.2024-26185
Identifier Type: -
Identifier Source: org_study_id
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