Daily Consumption of Dates for Metabolic Control and Oxidative Stress Improvement in Type 2 Diabetes
This study aims to evaluate the effects of daily date consumption on metabolic control and oxidative stress improvement in individuals with type 2 diabetes, by observing changes in fasting blood glucose, HbA1c, insulin resistance, lipid profile, and oxidative stress markers.
3 dates per day consumption
Diabetes Mellitus+5
+ Diabetes Mellitus, Type 2
+ Endocrine System Diseases
Prevention Study
Summary
Study start date: July 15, 2026
Actual date on which the first participant was enrolled.This study focuses on understanding how eating dates affects people with type 2 diabetes. Dates are packed with simple sugars, fiber, and antioxidants, but their impact on diabetes is not yet fully understood. Some reports suggest that moderate date consumption might raise blood sugar levels if added to the usual diet, while others indicate it could improve insulin sensitivity and balance out oxidative stress if used as a replacement for other carbohydrates. The study aims to evaluate the effect of daily consumption of 3 Deglet Nour dates for 8 weeks on blood sugar control and oxidative stress in 130 well-controlled type 2 diabetic patients. During the study, participants will have a baseline and final visit, 8 weeks apart, with clinical, dietary, and laboratory assessments. The 3 dates will replace a carbohydrate portion in their diet, such as a piece of fruit or dessert, ensuring no change in the total calorie intake. The study will measure changes in blood sugar control, insulin resistance, and oxidative stress markers. It will also monitor changes in weight, BMI, waist circumference, and blood pressure. The study will assess the participants' tolerance, adherence, satisfaction, and any adverse events. The goal is to determine whether moderate, isocaloric date consumption is safe and potentially beneficial for metabolic control and oxidative balance in patients with type 2 diabetes.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.130 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Age 18-65 years * Type 2 diabetes diagnosed for at least one year * Well-controlled diabetes on oral antidiabetic drugs for at least 3 months, with a target baseline HbA1c \< 8% * Duration of diabetes \< 15 years * Patient available for an 8-week period * Written informed consent Non-inclusion Criteria: * Patients on insulin therapy * Oral antidiabetic treatment modified within the 3 months prior to inclusion * Diabetes with established microvascular or macrovascular complications * Severe intercurrent diseases (severe renal insufficiency, severe liver disease, cardiovascular history, neoplasia, inflammatory disease) * Pregnancy or breastfeeding * Known allergy or intolerance to dates * Dietary regimens incompatible with isocaloric substitution (e.g., strict ketogenic diet, prolonged fasting) * Inability to understand or comply with study instructions (cognitive impairment, language barrier without interpreter, major logistical constraints) Exclusion Criteria: * Initiation of insulin therapy or major modification of antidiabetic treatment * Occurrence of pregnancy during the study * Development of a serious adverse event attributable to the intervention (e.g., persistent hyperglycemia, acute metabolic complications) * Patient refusal to continue the study or withdrawal of informed consent * Major non-adherence to the intervention (\<80% of planned intake or absence of isocaloric substitution) * Detection of a severe intercurrent condition requiring discontinuation of the intervention (e.g., heart failure decompensation, severe infection) * Loss to follow-up preventing the assessment of primary endpoints
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
La Rabta Hospital , Endocrinology Department
Tunis, TunisiaOpen La Rabta Hospital , Endocrinology Department in Google Maps