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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Type1diabetes
• Intervention / Treatment: Other: Omega Galil Hazelnut Chocolate Spread "O'Sweet Spread"; Other: Active Control-Nutella hazelnut cocoa spread

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alona Hamou, Msc; Phone Number: 972-3-9253778; Email: alonah@clalit.org.il

Study Locations

• Israel
  • Petach-Tikva, Israel
    • Recruiting
    • Schneider Children Medical Center of Israel
    • Contact: Alona Hamou, MSc; Phone Number: 972-545-950-277; Email: alonah@clalit.org.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Other: 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; Other Names: "O'Sweet Spread"
Active Comparator: 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	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; Other Names: Nutella hazelnut cocoa spread

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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	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)

Collaborators and Investigators

• Sponsor: Rabin Medical Center
• Collaborators: Omega 3 Galilee
• Investigators: Principal Investigator: Michal Gavan, PHd, Schneider Children's Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2024
• Primary Completion (Estimated): April 25, 2024
• Study Completion (Estimated): April 25, 2024

Study Registration Dates

• First Submitted: March 21, 2024
• First Submitted That Met QC Criteria: March 21, 2024
• First Posted (Actual): March 28, 2024

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: RMC0362-23ctil

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No