Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Omega 3 Galilee | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omega Galil O'Sweet hazelnut cocoa spread | Experimental | Omega Galil O'Sweet hazelnut cocoa spread is composed of 8% sucrose, 26% MCT oil, 6% cocoa butter, 6% cocoa powder, 10% Hazelnut paste, 24% fibers, 13% rice flour. It contains a total of 27.3 gram carbohydrates/ 100gram, 520 kcals/100 grams, and very low estimated GL according to healthy adults |
|
| Nutella hazelnut cocoa spread | Active Comparator | Nutella hazelnut cocoa spread is composed of 56% sugar, 30% vegetable fat, 13% Hazelnut paste, milk powder (8.7%), and cocoa powder (7.4%), containing a total of 57.5 grams carbohydrates /100grams, 532 kcals/100 grams, and an estimated GL of 4 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omega Galil Hazelnut Chocolate Spread "O'Sweet Spread" | Other | Omega Galil O'Sweet hazelnut cocoa spread is composed of 8% sucrose, 26% MCT oil, 6% cocoa butter, 6% cocoa powder, 10% Hazelnut paste, 24% fibers, 13% rice flour. It contains a total of 27.3 gram carbohydrates/ 100gram, 520 kcals/100 grams, and very low estimated GL according to healthy adults |
| Measure | Description | Time Frame |
|---|---|---|
| Delta postprandial glucose level | The difference between pre-meal and peak postprandial glucose level in each of the two 2 hours' meal tests. | first meal teat visit 1 (day 1) and second meal test visit 2 (2 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Incremental area under the curve (iAUC) | Incremental area under the curve (iAUC) using continuous glucose sensor data > 180 mg/dl between the beginning of the meal and 2 hours postprandial (defined as the postprandial period). | first meal teat visit 1 (day 1) and second meal test visit 2 (2 weeks) |
| Peak postprandial glucose level |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alona Hamou, Msc | Contact | 972-3-9253778 | alonah@clalit.org.il |
| Name | Affiliation | Role |
|---|---|---|
| Michal Gavan, PHd | Schneider Children's Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Schneider Children Medical Center of Israel | Recruiting | Petah Tikva | Israel |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Active Control-Nutella hazelnut cocoa spread | Other | Nutella hazelnut cocoa spread is composed of 56% sugar, 30% vegetable fat, 13% Hazelnut paste, milk powder (8.7%), and cocoa powder (7.4%), containing a total of 57.5 grams carbohydrates /100grams, 532 kcals/100 grams, and an estimated GL of 4 |
|
|
The peak postprandial glucose level during the 2-hour postprandial period |
| first meal teat visit 1 (day 1) and second meal test visit 2 (2 weeks) |
| Time in range (TIR) of 70-180 mg/dl | Time in range (TIR) of 70-180 mg/dl during the postprandial period | first meal teat visit 1 (day 1) and second meal test visit 2 (2 weeks) |
| Percentage of subjects who reached the desired glucose target | The percentage of subjects who reached the desired glucose target (70-180 mg/dl) during the postprandial period (70% of the time) | first meal teat visit 1 (day 1) and second meal test visit 2 (2 weeks) |
| The percentage of time spent above 180 mg/dl | The percentage of time spent above 180 mg/dl | first meal teat visit 1 (day 1) and second meal test visit 2 (2 weeks) |
| The percentage of time spent above 250 mg/dl | The percentage of time spent above 250 mg/dl | first meal teat visit 1 (day 1) and second meal test visit 2 (2 weeks) |
| The percentage of time spent above 350 md/dl | The percentage of time spent above 350 md/dl | first meal teat visit 1 (day 1) and second meal test visit 2 (2 weeks) |
| Labeled Magnitude Scale (gLMS) | Acceptance of the sweetness level Labeled Magnitude Scale (gLMS) | first meal teat visit 1 (day 1) and second meal test visit 2 (2 weeks) |