Type 2 DiabetesNCT06135935
Postprandial Glucose Response Using Mass-Market No-Added-Sugar Ice Cream
A study testing No-added-sugar ice cream and Conventional products in people with Type 2 Diabetes, run by Dasman Diabetes Institute at 1 site in Kuwait.
Trial summary
KDD is developing a new line of no-added-sugar products in line with its metabolic reengineering initiative and its metabolic matrix. The recipes fundamentally do not alter total saturated fat or protein levels and mainly offer the benefit of no added sugar and a significant reduction in net carbohydrates as well… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- No-added-sugar ice cream and Conventional products
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteKuwait
- Study dates
- 12 Nov 2023to 30 Jan 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes
- Aged over 18 years
- HbA1c 6.5-8.5% (48-69 mmol/L)
Who cannot join
- Lactose intolerant
- Not liking chocolate ice cream
Trial locations and contacts
1 site in 1 country.
Kuwait1 site, 1 recruiting
- Recruiting
Ebaa Al Ozairi
Kuwait City, Dasman, 15462
Ebaa Al Ozairi, MD, 22242999 ext. 3111, ebaa.alozairi@dasmaninstitute.org
Ebaa Al Ozairi, MD
About this study
Official title: Postprandial Glycaemic Changes When Patients With Type 2 Diabetes Consume the New KDD Products
KDD is developing a new line of no-added-sugar products in line with its metabolic reengineering initiative and its metabolic matrix. The recipes fundamentally do not alter total saturated fat or protein levels and mainly offer the benefit of no added sugar and a significant reduction in net carbohydrates as well glycaemic index.
Read the detailed description
The consumption of highly ultra-processed foods has been identified as having detrimental effects on human metabolic health, leading to various adverse health outcomes. The Metabolic Matrix represents a highly quantified, science-based tool for reengineering products with the aim of promoting positive metabolic outcomes. This approach may also contribute to creating shared value by solving important social problems such as obesity and type 2 diabetes by scalable products that are profitable.
KDD is committed to addressing the pandemic of metabolic diseases in Kuwait and would like to develop products that benefit the collective metabolic health of the Kuwait population. KDD is working with partners to assist in its ground-breaking work and to support its efforts with a strong evidence-base rooted in leading-edge science in metabolic health and nutrition. We hypothesise that no-added sugar-flavored ice cream have a substantially different postprandial glycaemic response compared to conventional products in patients with type 2 diabetes.
- Conditions
- Type 2 Diabetes
- Being tested
- No-added-sugar ice cream, Conventional products
- Keywords
- Type 2 diabetes, no added sugar-flavored ice cream, conventional ice cream, postprandial glycemic response
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No-added-sugar ice creamOther
The initial focus of this clinical trial will be the impact on postprandial glycaemia of 300g of ice cream, since, from a nutrition perspective, the flavored milks and ice creams are very similar in composition.
Conventional productsOther
The overconsumption of sugar-added conventional products leads to an increased risk of poor control of glycaemic levels.
| Study group | Role | What they receive |
|---|---|---|
| No-added-sugar ice cream | Experimental | KDD is developing a new line of no-added-sugar products in line with its metabolic reengineering initiative and its metabolic matrix. Four new flavored milks and four new ice creams all have no added sugar. Flavors include chocolate, vanilla, strawberry, and banana. The recipes fundamentally do not alter total saturated fat or protein levels and mainly offer the benefit of no added sugar and a significant reduction in net carbohydrates as well glycemic index. Receives: Other: No-added-sugar ice cream |
| conventional products | Active comparator | KDD has been a leading manufacturer of food and beverages with added sugar (conventional products). The majority of people with type 2 diabetes consume their food products. Receives: Other: Conventional products |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome will be area under curve for the plasma glucose response over 120 minutes after consumption of the ice creams.
The aim of this study is to test the postprandial glycemic response after consuming the new no added sugar-flavored ice cream compared to conventional products in patients with type 2 diabetes.
Measured: 8 months
Secondary outcomes (2)
Plasma insulin responses over 120 minutes after consumption of the ice creams.
Measured: 8 months
CGM monitor readouts over 24 hours after consumption of the ice creams.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start12 Nov 2023
- Primary completion12 Dec 2023 (estimated)
- Study completion30 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- In this double blind randomized controlled cross over design trial, patients will be randomized to receiving new KDD product or analog first. On the subsequent visit the opposite product will be provided.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dasman Diabetes Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Ebaa Al Ozairi, Dasman Diabetes Institute
- Investigators
- Ebaa Al Ozairi, MD, Principal investigator, Dasman Diabetes Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06135935
- Sponsor's protocol ID
- RA HM 2023-002
- Status last verified
- Nov 2023
- First submitted
- 12 Nov 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Al-Ozairi E, Mandani Y, Alfaleh G, Raj J, Alshammari S, Le Roux CW. Reformulating ice cream to improve postprandial glucose response: an opportunity for industry to create shared value. Front Nutr. 2024 Jul 16;11:1349392. doi: 10.3389/fnut.2024.1349392. eCollection 2024.
PubMed 39081682
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postprandial Glycaemic Changes When Patients With Type 2 Diabetes Consume the New KDD Products
- ClinicalTrials.gov ID
- NCT06135935
- Acronym / sponsor ID
- RA HM 2023-002
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 diabetes, no added sugar-flavored ice cream, conventional ice cream, postprandial glycemic response
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Dasman Diabetes InstituteUniversity, hospital or other
- Study start
- 12 Nov 2023 (actual)
- Primary completion
- 12 Dec 2023 (estimated)
- Study completion
- 30 Jan 2024 (estimated)
- First posted
- 18 Nov 2023 (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.
KDD is developing a new line of no-added-sugar products in line with its metabolic reengineering initiative and its metabolic matrix. The recipes fundamentally do not alter total saturated fat or protein levels and mainly offer the benefit of no added sugar and a significant reduction in net carbohydrates as well glycaemic index.
Detailed description
The consumption of highly ultra-processed foods has been identified as having detrimental effects on human metabolic health, leading to various adverse health outcomes. The Metabolic Matrix represents a highly quantified, science-based tool for reengineering products with the aim of promoting positive metabolic outcomes. This approach may also contribute to creating shared value by solving important social problems such as obesity and type 2 diabetes by scalable products that are profitable.
KDD is committed to addressing the pandemic of metabolic diseases in Kuwait and would like to develop products that benefit the collective metabolic health of the Kuwait population. KDD is working with partners to assist in its ground-breaking work and to support its efforts with a strong evidence-base rooted in leading-edge science in metabolic health and nutrition. We hypothesise that no-added sugar-flavored ice cream have a substantially different postprandial glycaemic response compared to conventional products in patients with type 2 diabetes.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- In this double blind randomized controlled cross over design trial, patients will be randomized to receiving new KDD product or analog first. On the subsequent visit the opposite product will be provided.
| Arm | Type | Receives |
|---|---|---|
| No-added-sugar ice cream | Experimental | Other: No-added-sugar ice creamKDD is developing a new line of no-added-sugar products in line with its metabolic reengineering initiative and its metabolic matrix. Four new flavored milks and four new ice creams all have no added sugar. Flavors include chocolate, vanilla, strawberry, and banana. The recipes fundamentally do not alter total saturated fat or protein levels and mainly offer the benefit of no added sugar and a significant reduction in net carbohydrates as well glycemic index. |
| conventional products | Active comparator | Other: Conventional productsKDD has been a leading manufacturer of food and beverages with added sugar (conventional products). The majority of people with type 2 diabetes consume their food products. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Type 2 diabetes
- Aged over 18 years
- HbA1c 6.5-8.5% (48-69 mmol/L)
Key exclusion criteria (2 listed)
- Lactose intolerant
- Not liking chocolate ice cream
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 |
|---|---|---|
| No-added-sugar ice creamThe initial focus of this clinical trial will be the impact on postprandial glycaemia of 300g of ice cream, since, from a nutrition perspective, the flavored milks and ice creams are very similar in composition. | Other | No-added-sugar ice cream |
| Conventional productsThe overconsumption of sugar-added conventional products leads to an increased risk of poor control of glycaemic levels. | Other | conventional products |
Primary outcome
The primary outcome will be area under curve for the plasma glucose response over 120 minutes after consumption of the ice creams.
Time frame: 8 months
The aim of this study is to test the postprandial glycemic response after consuming the new no added sugar-flavored ice cream compared to conventional products in patients with type 2 diabetes.
2 secondary outcomes
Plasma insulin responses over 120 minutes after consumption of the ice creams.
Time frame: 8 months
CGM monitor readouts over 24 hours after consumption of the ice creams.
Time frame: 8 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Derived from this study: PubMed 39081682Al-Ozairi E, Mandani Y, Alfaleh G, Raj J, Alshammari S, Le Roux CW. Reformulating ice cream to improve postprandial glucose response: an opportunity for industry to create shared value. Front Nutr. 2024 Jul 16;11:1349392. doi: 10.3389/fnut.2024.1349392. eCollection 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Type 2 Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
Ebaa Al Ozairi, MD principal investigator
Dasman Diabetes Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No-added-sugar ice cream and Conventional products in people with Type 2 Diabetes, run by Dasman Diabetes Institute at 1 site in Kuwait.
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 3 inclusion and 2 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 18 Nov 2023. 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 Kuwait. 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 Ebaa Al Ozairi (22242999 ext. 3111, ebaa.alozairi@dasmaninstitute.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome will be area under curve for the plasma glucose response over 120 minutes after consumption of the ice creams. (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06135935, which also lists 1 linked publication.
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 18 Nov 2023.