Clinical trial NCT06334302: The Effect of Omega Galil Hazelnut Chocolate Spread "O'Sweet Spread" With 80% Reduced Sucrose on Glucose Response of People With TID
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type1diabetes
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
Collaborators: name: Omega 3 Galilee
First posted: 2024-03-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: Omega Galil has developed a novel fatty sweetener that allows the use of up to 80% less sugar (particularly sucrose) and yet achieves a natural sweet flavor, using a novel technology of milling the natural sucrose crystals together with oil and thus creating a micro-suspension of sugar in oil or fat. The suspension increases the surface area of the sugar particles and thus a lower quantity of sugar is required in order to reach an enhanced perception of sweetness at the sweet taste receptors in the mouth. Omega Galil provides fatty food products that use up to 80% less sucrose, while tasting as sweet as regular sugar sweetened foods, with no aftertastes of sugar substitutes, and no chemical modifications or additives.

Postprandial glucose (PPG) excursions in Type 1 Diabetes happen mainly due to a delay in subcutaneous insulin absorption and action, but also among other factors, depend on the meal composition. The glycemic index (GI) ranks foods based on acute glycemic response over a 2-h period of 50 g of available carbohydrates (CHO) of a test food compared with the reference standard glucose. Glycemic Load (GL) is a GI-weighted measure of carbohydrate content, which estimates the impact of carbohydrate intake using the GI while taking into account the amount of carbohydrates that are eaten in a serving. Several studies have demonstrated differences in PPG after consumption of low versus high GI meals, with rapid glucose spikes following high GI meals . Helping people with T1D achieve a diet with a lower glycemic load can improve both their quality of life and their diabetes-associated complications.

The proposed randomized, double blind, cross-over, active control, clinical trial aims to:

1. compare the glycemic response of T1D subjects to 20 grams of the O'Sweet sugar-reduced spread containing 8% sugar and a total of 1.6 grams of sucrose per meal, with their glycemic response to 20 grams of control Nutella spread, containing 56% sugar and a total of 11 grams sucrose per meal.
2. compare the acceptance ("Not sweet enough, just right or too sweet") Labeled Magnitude score of O'Sweet compared to the control spread (Nutella).


Eligibility 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

Primary outcomes:
measure: Delta postprandial glucose level
timeFrame: first meal teat visit 1 (day 1) and second meal test visit 2 (2 weeks)
Secondary outcomes:
measure: Incremental area under the curve (iAUC)
timeFrame: first meal teat visit 1 (day 1) and second meal test visit 2 (2 weeks)
measure: Peak postprandial glucose level
timeFrame: first meal teat visit 1 (day 1) and second meal test visit 2 (2 weeks)
measure: Time in range (TIR) of 70-180 mg/dl
timeFrame: first meal teat visit 1 (day 1) and second meal test visit 2 (2 weeks)
measure: Percentage of subjects who reached the desired glucose target
timeFrame: first meal teat visit 1 (day 1) and second meal test visit 2 (2 weeks)
measure: The percentage of time spent above 180 mg/dl
timeFrame: first meal teat visit 1 (day 1) and second meal test visit 2 (2 weeks)
measure: The percentage of time spent above 250 mg/dl
timeFrame: first meal teat visit 1 (day 1) and second meal test visit 2 (2 weeks)
measure: The percentage of time spent above 350 md/dl
timeFrame: first meal teat visit 1 (day 1) and second meal test visit 2 (2 weeks)
measure: Labeled Magnitude Scale (gLMS)
timeFrame: first meal teat visit 1 (day 1) and second meal test visit 2 (2 weeks)
Other outcomes:
Locations:
city: Petach-Tikva
country: Israel
facility: Schneider Children Medical Center of Israel
Study officials:
affiliation: Schneider Children's Medical Center
name: Michal Gavan, PHd
role: PRINCIPAL_INVESTIGATOR
References: