Effect of a low-sugar hazelnut chocolate spread on glucose response in Type 1 Diabetes
The Effect of Omega Galil Hazelnut Chocolate Spread "O'Sweet Spread" With 80% Reduced Sucrose on Glucose Response of People With TID - a Randomized, Double-blind, Active Control Trial
This study tests whether a low-sugar hazelnut chocolate spread can help people with Type 1 Diabetes manage their blood sugar levels better after eating.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 35 Years |
| Sex | All |
| Sponsor | Rabin Medical Center Academic / other |
| Locations | 1 site (Petach-Tikva) |
| Trial ID | NCT06334302 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of Omega Galil's O'Sweet Spread, which contains 80% less sucrose, on postprandial glucose levels in individuals with Type 1 Diabetes. The spread utilizes a novel technology that combines sugar with oil to enhance sweetness perception while reducing sugar content. Participants will consume the spread and their glucose responses will be monitored, comparing it to a standard hazelnut cocoa spread. The study aims to determine if this innovative product can improve glycemic control in patients with Type 1 Diabetes.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18-35 with Type 1 Diabetes for more than one year, normal weight, and using Continuous Glucose Monitoring.
Not a fit: Patients with gastrointestinal conditions, chronic illnesses, or those on medications other than insulin may not benefit from this study.
Why it matters
Potential benefit: If successful, this could lead to better glucose management for patients with Type 1 Diabetes, potentially reducing the risk of postprandial hyperglycemia.
How similar studies have performed: While the approach of reducing sugar content in food products is common, the specific application of this novel technology in Type 1 Diabetes management is relatively untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * T1D patients with diabetes duration \>1 year * 18-35 years of age * Normal weight (BMI 20- 30 kg/m2) * Non-smoker * Hemoglobin A1C \<9% * Patient treated with Continuous Glucose Monitoring system (CGM's) Exclusion Criteria: * Acute Upper Respiratory Tract Infection (URTI) within 2 weeks of enrollment * A gastro-intestinal condition that could disrupt intestinal absorption or motility, and thereby impair postprandial glucose absorption (e.g. diabetic gastroparesis, celiac disease, or malabsorption). * A chronic illness in the past 5 years, including among others inflammatory, metabolic, neoplastic, and congenital disease. * Use of medications other than insulin (e.g. Antibiotics/antifungal, analgesics) during the study and 2 weeks before enrollment; * Neuro-psychiatric disorders * Known food allergies or intolerances * Self-reported sinus, taste or smell dysfunction * Pregnant or lactating women
Where this trial is running
Petach-Tikva
- Schneider Children Medical Center of Israel — Petach-Tikva, Israel (Recruiting)
Study contacts
- Principal investigator: Michal Gavan, PHd — Schneider Children's Medical Center
- Study coordinator: Alona Hamou, Msc
- Email: alonah@clalit.org.il
- Phone: 972-3-9253778
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.