About this trial
Summary
Dates, rich in simple sugars, fiber, and antioxidant polyphenols, have a variable glycemic index and conflicting reported effects on type 2 diabetes. Moderate consumption might raise glycemia if added to the usual diet, but could improve insulin sensitivity and oxidative balance if used as an isocaloric substitute.
This prospective, interventional, single-center study (Endocrinology Department., La Rabta Hospital, Tunis) aims to evaluate the effect of daily consumption of 3 Deglet Nour dates for 8 weeks on glycemic control and oxidative stress in 130 well-controlled type 2 diabetic patients.
Primary objectives:
Assess changes in HbA1c, fasting glucose, and HOMA-IR. Measure variations in oxidative stress markers (MDA, SOD, TAC, pentosidine).
Secondary objectives:
Monitor changes in weight, BMI, waist circumference, and blood pressure. Assess tolerance, adherence, satisfaction, and adverse events.
Study design:
Baseline and final visits (week 0 and week 8) with clinical, dietary, and laboratory assessments.
Isocaloric substitution: 3 dates replace a carbohydrate portion (e.g., fruit or dessert).
No change in antidiabetic therapy or lifestyle allowed.
Endpoints:
Primary: ΔHbA1c, Δfasting glucose, ΔHOMA-IR, and oxidative markers. Secondary: Anthropometrics, blood pressure, safety, adherence, lipid and metabolic parameters.
Expected outcome: determine whether moderate, isocaloric date consumption is safe and potentially beneficial for metabolic control and oxidative balance in Tunisian patients with type 2 diabetes.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- 3 dates per day consumption