NCT06135935

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable type-2-diabetes

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 12, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

November 12, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2024

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

1 month

First QC Date

November 12, 2023

Last Update Submit

November 12, 2023

Conditions

Type 2 Diabetes

Keywords

Type 2 diabetesno added sugar-flavored ice creamconventional ice creampostprandial glycemic response

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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

Study Arms (2)

No-added-sugar ice cream

EXPERIMENTAL

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

conventional products

ACTIVE COMPARATOR

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

Interventions

No-added-sugar ice creamOTHER

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.

No-added-sugar ice cream
Conventional productsOTHER

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

conventional products

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes
  • Aged over 18 years
  • HbA1c 6.5-8.5% (48-69 mmol/L)

You may not qualify if:

  • Lactose intolerant
  • Not liking chocolate ice cream

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ebaa Al Ozairi

Kuwait City, Dasman, 15462, Kuwait

RECRUITING

Related Publications (1)

  • 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.

    PMID: 39081682DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Ebaa Al Ozairi, MD

    Dasman Diabetes Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ebaa Al Ozairi

CONTACT

22242999ebaa.alozairi@dasmaninstitute.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SCREENING
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
CMO

Study Record Dates

First Submitted

November 12, 2023

First Posted

November 18, 2023

Study Start

November 12, 2023

Primary Completion

December 12, 2023

Study Completion

January 30, 2024

Last Updated

November 18, 2023

Record last verified: 2023-11

Locations

KU(1)