Impact of Date Consumption on Metabolic Control and Oxidative Stress in Patients With Type 2 Diabetes

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Diabete Type 2
• Intervention / Treatment: Dietary supplement: 3 dates per day consumption

• Study Type: Interventional
• Enrollment (Estimated): 130
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: CHAYMA BEL HADJ SLIMAN, Hospital-University Physician; Phone Number: +21655204179; Email: bhschaima@yahoo.com

Study Locations

• Tunisia
  • Tunis, Tunisia, 1
    • La Rabta Hospital , Endocrinology Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Type 2 diabetic patients; Adults aged 18-65 years with type 2 diabetes diagnosed for at least one year, well-controlled on oral antidiabetic therapy for at least 3 months (baseline HbA1c < 8%), with a disease duration of less than 15 years, available for an 8-week study period, and providing written informed consent.	Dietary supplement: 3 dates per day consumption; The intervention is date fruit consumption (3 dates per day) incorporated into the daily diet of patients with type 2 diabetes, following an isocaloric substitution plan for a duration of 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in HbA1c		between M3 (Week 12) and M0 (baseline),)
Change in Fasting blood glucose		Between M3 ( week 12) and M0 (baseline)
change in oxidative stress markers	MDA (malondialdehyde) SOD ( Superoxide Dismutase) pentosidine TAC (Total Antioxidant Capacity)	Between M3 ( week 12) and M0 (baseline)
change in lipid profile	Total Cholesterol Triglycerides HDL cholesterol LDL Cholesterol	Between M3 ( week 12) and M0 (baseline)
change in Insulin resistance (HOMA-IR)	Δ (M2-M0), calculated from fasting insulin and glucose (standard formula).	Between M3 ( week 12) and M0 (baseline)

Secondary Outcome Measures

Outcome Measure	Time Frame
Weight's variation	Between M3 ( week 12) and M0 (baseline)
change in Body Mass Index	Between M3 ( week 12) and M0 (baseline)
change in blood pressure	Between M3 ( week 12) and M0 (baseline)

Collaborators and Investigators

• Sponsor: University Tunis El Manar

Study record dates

Study Major Dates

• Study Start (Estimated): July 15, 2026
• Primary Completion (Estimated): February 20, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: March 8, 2026
• First Submitted That Met QC Criteria: March 8, 2026
• First Posted (Actual): March 12, 2026

Study Record Updates

• Last Update Posted (Actual): March 12, 2026
• Last Update Submitted That Met QC Criteria: March 8, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Antioxidants; Insulin Resistance; Prospective Studies; Oxidative Stress; Diabetes Mellitus, Type 2; Blood Pressure; Blood Glucose; Body Mass Index; Dietary Intervention; Polyphenols; Metabolic Control; Nutritional Status; Lipid Profile; Waist Circumference; Dates (Phoenix dactylifera); Glycated Hemoglobin A (HbA1c)
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Hyperinsulinism; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Insulin Resistance
• Other Study ID Numbers: RE002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No