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

NCT07467967 | Not Yet Recruiting

• 1 other identifier: RE002
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabete Type 2

Keywords

Dates (Phoenix dactylifera); Antioxidants; Polyphenols; Oxidative Stress; Diabetes Mellitus, Type 2; Blood Glucose; Glycated Hemoglobin A (HbA1c); Insulin Resistance; Metabolic Control; Body Mass Index; Waist Circumference; Blood Pressure; Lipid Profile; Prospective Studies; Nutritional Status; Dietary Intervention

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• 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)

Study Arms (1)

Type 2 diabetic patients

EXPERIMENTAL

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

Interventions

3 dates per day consumption DIETARY_SUPPLEMENT

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.

Type 2 diabetic patients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Patients on insulin therapy
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Tunis El Manar: lead

Study Sites (1)

La Rabta Hospital , Endocrinology Department

Tunis, 1, Tunisia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance

Condition Hierarchy (Ancestors)

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

Central Study Contacts

CHAYMA BEL HADJ SLIMAN, Hospital-University Physician

CONTACT

+21655204179; bhschaima@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Hospital-University Physician

Study Record Dates

• First Submitted: March 8, 2026
• First Posted: March 12, 2026
• Study Start (Estimated): July 15, 2026
• Primary Completion (Estimated): February 20, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 12, 2026

Record last verified: 2026-03

Locations

TU (1)