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

November 12, 2023 updated by: Dr. Ebaa Al Ozairi, Dasman Diabetes Institute

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Kuwait
    • Dasman
      • Kuwait City, Dasman, Kuwait, 15462
        • Recruiting
        • Ebaa Al Ozairi
        • Contact:
        • Principal Investigator:
          • Ebaa Al Ozairi, MD
        • Sub-Investigator:
          • Ghanima Alfaleh, MD
        • Sub-Investigator:
          • Carel Le Roux, MD, Ph.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Active Comparator: 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.
Other: Conventional products
The overconsumption of sugar-added conventional products leads to an increased risk of poor control of glycaemic levels.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Plasma insulin responses over 120 minutes after consumption of the ice creams.
Time Frame: 8 months
8 months
CGM monitor readouts over 24 hours after consumption of the ice creams.
Time Frame: 8 months
8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dasman Diabetes Institute

Investigators

  • Principal Investigator: Ebaa Al Ozairi, MD, Dasman Diabetes Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 12, 2023

Primary Completion (Estimated)

December 12, 2023

Study Completion (Estimated)

January 30, 2024

Study Registration Dates

First Submitted

November 12, 2023

First Submitted That Met QC Criteria

November 12, 2023

First Posted (Estimated)

November 16, 2023

Study Record Updates

Last Update Posted (Estimated)

November 16, 2023

Last Update Submitted That Met QC Criteria

November 12, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RA HM 2023-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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