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

Type 2 Diabetes Clinical Trial

Official title:

Postprandial Glycaemic Changes When Patients With Type 2 Diabetes Consume the New KDD Products

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06135935
• Other study ID #: RA HM 2023-002
• Status: Recruiting
• Phase: N/A
• Start date: November 12, 2023
• Est. completion date: January 30, 2024

Study information

• Verified date: November 2023
• Source: Dasman Diabetes Institute
• Contact: Ebaa Al Ozairi
• Phone: 22242999
• Email: ebaa.alozairi[@]dasmaninstitute.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 glycaemic index.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: January 30, 2024
• Est. primary completion date: December 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Other:
• No-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.
• Conventional products
The overconsumption of sugar-added conventional products leads to an increased risk of poor control of glycaemic levels.

Locations

Country	Name	City	State
Kuwait	Ebaa Al Ozairi	Kuwait City	Dasman

Sponsors (1)

Lead Sponsor	Collaborator
Dasman Diabetes Institute

Country where clinical trial is conducted

Kuwait, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	8 months
Secondary	Plasma insulin responses over 120 minutes after consumption of the ice creams.		8 months
Secondary	CGM monitor readouts over 24 hours after consumption of the ice creams.		8 months