Postprandial Glucose Response Using Mass-Market No-Added-Sugar Ice Cream

Not Applicable

Recruiting

• Conditions: Type 2 Diabetes
• Interventions: Other: Conventional products; Other: No-added-sugar ice cream

• Registration Number: NCT06135935
• Lead Sponsor: Dasman Diabetes Institute

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.

Study Timeline

• Status Verified: 2023-11
• Study Start: 2023-11-12
• Study First Submitted: 2023-11-12
• Study First Submitted QC: 2023-11-12
• Last Update Submitted: 2023-11-12
• Study First Posted: 2023-11-18
• Last Update Posted: 2023-11-18
• Primary Completion: 2023-12-12
• Study Completion: 2024-01-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
conventional products	Conventional products	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.
No-added-sugar ice cream	No-added-sugar ice cream	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
CGM monitor readouts over 24 hours after consumption of the ice creams.	8 months
Plasma insulin responses over 120 minutes after consumption of the ice creams.	8 months

Trial Locations

Locations (1)

Ebaa Al Ozairi; 🇰🇼 Kuwait City, Dasman, Kuwait