Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06334302
Status:
RECRUITING
Last Update Posted:
2024-04-12
First Post:
2024-03-21
Brief Title:
The Effect of Omega Galil Hazelnut Chocolate Spread OSweet Spread With 80 Reduced Sucrose on Glucose Response of People With TID
Sponsor:
Rabin Medical Center
Organization:
Rabin Medical Center
Study Overview
Official Title:
The Effect of Omega Galil Hazelnut Chocolate Spread OSweet Spread With 80 Reduced Sucrose on Glucose Response of People With TID - a Randomized Double-blind Active Control Trial
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 OSweet sugar-reduced spread containing 8 sugar and a total of 16 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 OSweet compared to the control spread Nutella
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 OSweet sugar-reduced spread containing 8 sugar and a total of 16 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 OSweet compared to the control spread Nutella
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None