Type1diabetesNCT06334302
The Effect of Omega Galil Hazelnut Chocolate Spread "O'Sweet Spread" With 80% Reduced Sucrose on Glucose Response of People With TID
A study testing Omega Galil Hazelnut Chocolate Spread "O'Sweet Spread" in people with Type1diabetes, run by Rabin Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Type1diabetes
- What is being tested?
- Omega Galil Hazelnut Chocolate Spread "O'Sweet Spread"
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- 25 Mar 2024to 25 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Schneider Children Medical Center of Israel
Petah Tikva
Alona Hamou, MSc, 972-545-950-277, alonah@clalit.org.il
About this study
Official title: 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.
Read more
The proposed randomized, double blind, cross-over, active control, clinical trial aims to:
- 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.
- 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
- Being tested
- Omega Galil Hazelnut Chocolate Spread "O'Sweet Spread", Active Control-Nutella hazelnut cocoa spread
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega Galil Hazelnut Chocolate Spread "O'Sweet Spread"Other
Also called "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
Active Control-Nutella hazelnut cocoa spreadOther
Also called 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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Active Control-Nutella hazelnut cocoa spread |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delta postprandial glucose level
The difference between pre-meal and peak postprandial glucose level in each of the two 2 hours' meal tests.
Measured: first meal teat visit 1 (day 1) and second meal test visit 2 (2 weeks)
Secondary outcomes (8)
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).
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: first meal teat visit 1 (day 1) and second meal test visit 2 (2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start25 Mar 2024
- Primary completion25 Apr 2024 (estimated)
- Study completion25 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type1diabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Omega 3 Galilee
- Responsible party
- Sponsor
- Investigators
- Michal Gavan, PHd, Principal investigator, Schneider Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06334302
- Sponsor's protocol ID
- RMC0362-23ctil
- Status last verified
- Mar 2024
- First submitted
- 21 Mar 2024
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06334302
- Acronym / sponsor ID
- RMC0362-23ctil
- Conditions
- Type1diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Collaborators
- Omega 3 Galilee
- Study start
- 25 Mar 2024 (actual)
- Primary completion
- 25 Apr 2024 (estimated)
- Study completion
- 25 Apr 2024 (estimated)
- First posted
- 28 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- compare the acceptance ("Not sweet enough, just right or too sweet") Labeled Magnitude score of O'Sweet compared to the control spread (Nutella).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omega Galil O'Sweet hazelnut cocoa spread | Experimental | 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 |
| Nutella hazelnut cocoa spread | Active comparator | Other: Active Control-Nutella hazelnut cocoa spreadNutella 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 |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- T1D patients with diabetes duration >1 year
- 18-35 years of age
- Normal weight (BMI 20- 30 kg/m2)
- Non-smoker
- Hemoglobin A1C <9%
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega Galil Hazelnut Chocolate Spread "O'Sweet Spread"Also: "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 | Omega Galil O'Sweet hazelnut cocoa spread |
| Active Control-Nutella hazelnut cocoa spreadAlso: Nutella hazelnut cocoa spreadNutella 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 | Nutella hazelnut cocoa spread |
Primary outcome
Delta postprandial glucose level
Time frame: first meal teat visit 1 (day 1) and second meal test visit 2 (2 weeks)
The difference between pre-meal and peak postprandial glucose level in each of the two 2 hours' meal tests.
8 secondary outcomes
Incremental area under the curve (iAUC)
Time frame: first meal teat visit 1 (day 1) and second meal test visit 2 (2 weeks)
Peak postprandial glucose level
Time frame: 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 frame: first meal teat visit 1 (day 1) and second meal test visit 2 (2 weeks)
Percentage of subjects who reached the desired glucose target
Time frame: first meal teat visit 1 (day 1) and second meal test visit 2 (2 weeks)
The percentage of time spent above 180 mg/dl
Time frame: first meal teat visit 1 (day 1) and second meal test visit 2 (2 weeks)
The percentage of time spent above 250 mg/dl
Time frame: first meal teat visit 1 (day 1) and second meal test visit 2 (2 weeks)
The percentage of time spent above 350 md/dl
Time frame: first meal teat visit 1 (day 1) and second meal test visit 2 (2 weeks)
Labeled Magnitude Scale (gLMS)
Time frame: first meal teat visit 1 (day 1) and second meal test visit 2 (2 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michal Gavan, PHd principal investigator
Schneider Children's Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omega Galil Hazelnut Chocolate Spread "O'Sweet Spread" in people with Type1diabetes, run by Rabin Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alona Hamou, Msc (972-3-9253778, alonah@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delta postprandial glucose level (time frame: first meal teat visit 1 (day 1) and second meal test visit 2 (2 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2024.