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NCT Number: NCT07467967

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

La Rabta Hospital , Endocrinology Department

Tunis, 1, Tunisia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in HbA1c

    Time frame: between M3 (Week 12) and M0 (baseline),)

  2. Change in Fasting blood glucose

    Time frame: Between M3 ( week 12) and M0 (baseline)

  3. change in oxidative stress markers

    Time frame: Between M3 ( week 12) and M0 (baseline)

    MDA (malondialdehyde)

    SOD ( Superoxide Dismutase)

    pentosidine

    TAC (Total Antioxidant Capacity)

  4. change in lipid profile

    Time frame: Between M3 ( week 12) and M0 (baseline)

    Total Cholesterol Triglycerides HDL cholesterol LDL Cholesterol

  5. change in Insulin resistance (HOMA-IR)

    Time frame: Between M3 ( week 12) and M0 (baseline)

    Δ (M2-M0), calculated from fasting insulin and glucose (standard formula).

Secondary outcomes

  1. Weight's variation

    Time frame: Between M3 ( week 12) and M0 (baseline)

  2. change in Body Mass Index

    Time frame: Between M3 ( week 12) and M0 (baseline)

  3. change in blood pressure

    Time frame: Between M3 ( week 12) and M0 (baseline)

Study contacts

Contact information is provided by the study sponsor or research team.

CHAYMA BEL HADJ SLIMAN, Hospital-University Physician

CONTACT

[email protected]

+21655204179

Sponsors and collaborators

Lead sponsor

University Tunis El Manar

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 12, 2026
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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