An interventional study of 3 dates per day consumption in Diabete Type 2, sponsored by University Tunis El Manar. Not yet recruiting at 1 site in Tunisia. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-03-12.
Sponsored by University Tunis El Manar · Not applicable, Interventional, and Prevention
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.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's planned enrollment of 130 is above the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →University Tunis El Manar is the lead sponsor of 74 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Non-inclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Change in HbA1c
Time frame: between M3 (Week 12) and M0 (baseline),)
Change in Fasting blood glucose
Time frame: Between M3 ( week 12) and M0 (baseline)
change in oxidative stress markers
MDA (malondialdehyde) SOD ( Superoxide Dismutase) pentosidine TAC (Total Antioxidant Capacity)
Time frame: Between M3 ( week 12) and M0 (baseline)
change in lipid profile
Total Cholesterol Triglycerides HDL cholesterol LDL Cholesterol
Time frame: Between M3 ( week 12) and M0 (baseline)
change in Insulin resistance (HOMA-IR)
Δ (M2-M0), calculated from fasting insulin and glucose (standard formula).
Time frame: Between M3 ( week 12) and M0 (baseline)
Weight's variation
Time frame: Between M3 ( week 12) and M0 (baseline)
change in Body Mass Index
Time frame: Between M3 ( week 12) and M0 (baseline)
change in blood pressure
Time frame: Between M3 ( week 12) and M0 (baseline)
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Jul 2026; primary completion for Feb 2027, 7 months later.
Of 2,066 non-industry interventional studies with no phase under Diabetes Mellitus, Type 2, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 40. This study's planned 7 months is below that.
Counting every sponsor, half of 2,243 studies reached it within 21 months; a quarter within 10 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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University Tunis El Manar