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

NCT ID: NCT06135935

Last Updated: 2023-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-12

Study Completion Date

2024-01-30

Brief Summary

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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

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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

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

No-added-sugar ice cream

Intervention Type OTHER

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

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.

Group Type ACTIVE_COMPARATOR

Conventional products

Intervention Type OTHER

The overconsumption of sugar-added conventional products leads to an increased risk of poor control of glycaemic levels.

Interventions

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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.

Intervention Type OTHER

Conventional products

The overconsumption of sugar-added conventional products leads to an increased risk of poor control of glycaemic levels.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dasman Diabetes Institute

OTHER

Sponsor Role lead

Responsible Party

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Dr. Ebaa Al Ozairi

CMO

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ebaa Al Ozairi, MD

Role: PRINCIPAL_INVESTIGATOR

Dasman Diabetes Institute

Locations

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Ebaa Al Ozairi

Kuwait City, Dasman, Kuwait

Site Status RECRUITING

Countries

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Kuwait

Central Contacts

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Ebaa Al Ozairi

Role: CONTACT

22242999 ext. 3111

Facility Contacts

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Ebaa Al Ozairi, MD

Role: primary

22242999 ext. 3111

References

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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.

Reference Type DERIVED
PMID: 39081682 (View on PubMed)

Other Identifiers

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RA HM 2023-002

Identifier Type: -

Identifier Source: org_study_id

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