Investigation of the Effect of Date Consumption on Hedonic Hunger and Appetite in Adult Individuals With Type 2 Diabetes

NCT06826235 | Recruiting

• 1 other identifier: 06.03.2024-26185
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Type 2 Diabetes Mellitus; Appetite

Keywords

date; hedonic hunger; appetite; type 2 diabetes; lipid profile

Outcome Measures

Primary Outcomes (2)

• Appetite hormone levels

  GLP-1, GIP and Ghrelin hormone levels in plasma will be measured in pg/ml.

  3 months

• Hedonic hunger levels

  Hedonic hunger levels of individuals will be determined using the Power of Food Scale (PFS).

  3 months

Study Arms (2)

INTERVENTION GROUP

EXPERIMENTAL

Other: 3 dates at the breakfast meal in the diet program

CONTROL GROUP

NO INTERVENTION

Interventions

3 dates at the breakfast meal in the diet program OTHER

Participants in the intervention group will consume 3 dates at the breakfast meal in the diet program.

INTERVENTION GROUP

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Individuals taking antibiotics or hormone replacement therapy History of malignancy (except non-melanoma skin cancer).
• 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.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Erzurum City Hospital

Erzurum, Palandöken, 25070, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

AYŞE ÇAMLİ

CONTACT

+905364254169; aysecamli1996@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: control and intervention group

Study Record Dates

• First Submitted: January 23, 2025
• First Posted: February 13, 2025
• Study Start: May 14, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)