Diabete Type 2NCT07467967
Impact of Date Consumption on Metabolic Control and Oxidative Stress in Patients With Type 2 Diabetes
A study testing 3 dates per day consumption in people with Diabete Type 2, run by University Tunis El Manar at 1 site in Tunisia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabete Type 2
- What is being tested?
- 3 dates per day consumption
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteTunisia
- Study dates
- 15 Jul 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 15Show fewer
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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
- Being tested
- 3 dates per day consumption
- 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
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3 dates per day consumptionDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: 3 dates per day consumption |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c
Measured: between M3 (Week 12) and M0 (baseline),)
Change in Fasting blood glucose
Measured: Between M3 ( week 12) and M0 (baseline)
change in oxidative stress markers
MDA (malondialdehyde)
SOD ( Superoxide Dismutase)
pentosidine
TAC (Total Antioxidant Capacity)
Measured: Between M3 ( week 12) and M0 (baseline)
change in lipid profile
Total Cholesterol Triglycerides HDL cholesterol LDL Cholesterol
Measured: Between M3 ( week 12) and M0 (baseline)
change in Insulin resistance (HOMA-IR)
Δ (M2-M0), calculated from fasting insulin and glucose (standard formula).
Measured: Between M3 ( week 12) and M0 (baseline)
Secondary outcomes (3)
Weight's variation
Measured: Between M3 ( week 12) and M0 (baseline)
change in Body Mass Index
Measured: Between M3 ( week 12) and M0 (baseline)
change in blood pressure
Measured: Between M3 ( week 12) and M0 (baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start15 Jul 2026 (estimated)
- Primary completion20 Feb 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabete Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Tunis El Manar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chayma Bel Hadj Sliman, University Tunis El Manar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07467967
- Sponsor's protocol ID
- RE002
- Status last verified
- Mar 2026
- First submitted
- 8 Mar 2026
- Last updated
- 12 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Date Consumption on Metabolic Control and Oxidative Stress in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT07467967
- Acronym / sponsor ID
- RE002
- Conditions
- Diabete Type 2
- Keywords
- Dates (Phoenix dactylifera), Antioxidants, Polyphenols, Oxidative Stress, Diabetes Mellitus, Type 2, Blood Glucose, Glycated Hemoglobin A (HbA1c), Insulin Resistance
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- University Tunis El ManarUniversity, hospital or other
- Study start
- 15 Jul 2026 (estimated)
- Primary completion
- 20 Feb 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Type 2 diabetic patients | Experimental | Dietary Supplement: 3 dates per day consumptionAdults 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3 dates per day consumptionThe 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. | Dietary supplement | Type 2 diabetic patients |
Primary outcome
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
Time frame: Between M3 ( week 12) and M0 (baseline)
MDA (malondialdehyde) SOD ( Superoxide Dismutase) pentosidine TAC (Total Antioxidant Capacity)
change in lipid profile
Time frame: Between M3 ( week 12) and M0 (baseline)
Total Cholesterol Triglycerides HDL cholesterol LDL Cholesterol
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).
3 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Diabete Type 2
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3 dates per day consumption in people with Diabete Type 2, run by University Tunis El Manar at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact CHAYMA BEL HADJ SLIMAN, Hospital-University Physician (+21655204179, bhschaima@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c (time frame: between M3 (Week 12) and M0 (baseline),)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.