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

NCT06334302 | Recruiting

• 1 other identifier: RMC0362-23ctil
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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. 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. 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Incremental area under the curve (iAUC)

  first meal teat visit 1 (day 1) and second meal test visit 2 (2 weeks)

• Peak postprandial glucose level

  first meal teat visit 1 (day 1) and second meal test visit 2 (2 weeks)

• Time in range (TIR) of 70-180 mg/dl

  first meal teat visit 1 (day 1) and second meal test visit 2 (2 weeks)

• Percentage of subjects who reached the desired glucose target

  first meal teat visit 1 (day 1) and second meal test visit 2 (2 weeks)

• The percentage of time spent above 180 mg/dl

  first meal teat visit 1 (day 1) and second meal test visit 2 (2 weeks)

Study Arms (2)

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

Other: Omega Galil Hazelnut Chocolate Spread "O'Sweet Spread"

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

Other: Active Control-Nutella hazelnut cocoa spread

Interventions

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

Also known as: "O'Sweet Spread"

Omega Galil O'Sweet hazelnut cocoa spread

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

Also known as: Nutella hazelnut cocoa spread

Nutella hazelnut cocoa spread

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• T1D patients with diabetes duration \>1 year
• years of age
• Normal weight (BMI 20- 30 kg/m2)
• Non-smoker
• Hemoglobin A1C \<9%
• Patient treated with Continuous Glucose Monitoring system (CGM's)

You may not qualify if:

• 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

Sponsors & Collaborators

• Rabin Medical Center: lead
• Omega 3 Galilee: collaborator

Study Sites (1)

Schneider Children Medical Center of Israel

Petah Tikva, Israel

RECRUITING

Study Officials

• Michal Gavan, PHd

  Schneider Children's Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alona Hamou, Msc

CONTACT

972-3-9253778; alonah@clalit.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: March 28, 2024
• Study Start: March 25, 2024
• Primary Completion: April 25, 2024
• Study Completion: April 25, 2024
• Last Updated: April 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)