La Rabta Hospital , Endocrinology Department
Tunis, 1, Tunisia
NCT Number: NCT07467967
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.
Trial opening soon.
Get Notified18 year–65 year
All sexes
Interventional
Not applicable
Tunis, 1, Tunisia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Non-inclusion Criteria:
Exclusion criteria
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.
Time frame: between M3 (Week 12) and M0 (baseline),)
Time frame: Between M3 ( week 12) and M0 (baseline)
Time frame: Between M3 ( week 12) and M0 (baseline)
MDA (malondialdehyde)
SOD ( Superoxide Dismutase)
pentosidine
TAC (Total Antioxidant Capacity)
Time frame: Between M3 ( week 12) and M0 (baseline)
Total Cholesterol Triglycerides HDL cholesterol LDL Cholesterol
Time frame: Between M3 ( week 12) and M0 (baseline)
Δ (M2-M0), calculated from fasting insulin and glucose (standard formula).
Time frame: Between M3 ( week 12) and M0 (baseline)
Time frame: Between M3 ( week 12) and M0 (baseline)
Time frame: Between M3 ( week 12) and M0 (baseline)
Contact information is provided by the study sponsor or research team.
University Tunis El Manar
Other
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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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