The Effect of Omega Galil Hazelnut Chocolate Spread "O'Sweet Spread" With 80% Reduced Sucrose on Glucose Response of People With TID

NCT ID: NCT06334302

Last Updated: 2024-04-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-25
• Study Completion Date: 2024-04-25

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).

Conditions

Type1diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Omega Galil O'Sweet hazelnut cocoa spread

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

Group Type: EXPERIMENTAL

Omega Galil Hazelnut Chocolate Spread "O'Sweet Spread"

Intervention Type: 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

Nutella hazelnut cocoa spread

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

Group Type: ACTIVE_COMPARATOR

Active Control-Nutella hazelnut cocoa spread

Intervention Type: 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

Interventions

Omega Galil Hazelnut Chocolate Spread "O'Sweet Spread"

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

Intervention Type: OTHER

Active Control-Nutella hazelnut cocoa spread

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

Intervention Type: OTHER

Other Intervention Names

"O'Sweet Spread"; Nutella hazelnut cocoa spread

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Omega 3 Galilee

UNKNOWN

Sponsor Role: collaborator

Rabin Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michal Gavan, PHd

Role: PRINCIPAL_INVESTIGATOR

Schneider Children's Medical Center

Locations

Schneider Children Medical Center of Israel

Petah Tikva, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Alona Hamou, Msc

Role: CONTACT

alonah@clalit.org.il

972-3-9253778

Facility Contacts

Alona Hamou, MSc

Role: primary

alonah@clalit.org.il

972-545-950-277

Other Identifiers

RMC0362-23ctil

Identifier Type: -

Identifier Source: org_study_id