Type 2 Diabetes
Conditions
Keywords
Type 2 diabetes, no added sugar-flavored ice cream, conventional ice cream, postprandial glycemic response
Brief 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 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.
Interventions
OTHERNo-added-sugar ice cream
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.
The overconsumption of sugar-added conventional products leads to an increased risk of poor control of glycaemic levels.
Sponsors
Dasman Diabetes Institute
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SCREENING
Masking
SINGLE (Subject)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Type 2 diabetes 2. Aged over 18 years 3. HbA1c 6.5-8.5% (48-69 mmol/L)
Exclusion criteria
1. Lactose intolerant 2. Not liking chocolate ice cream
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary outcome will be area under curve for the plasma glucose response over 120 minutes after consumption of the ice creams. | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Plasma insulin responses over 120 minutes after consumption of the ice creams. | 8 months |
| CGM monitor readouts over 24 hours after consumption of the ice creams. | 8 months |
Countries
Kuwait
Contacts
Primary ContactEbaa Al Ozairi
Outcome results
None listed