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

Sponsor
Dasman Diabetes Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT06135935
Collaborator
(none)
12
1
2
2.6
4.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: No-added-sugar ice cream
  • Other: Conventional products
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
12 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
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.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.
Masking:
Single (Participant)
Primary Purpose:
Screening
Official Title:
Postprandial Glycaemic Changes When Patients With Type 2 Diabetes Consume the New KDD Products
Actual Study Start Date :
Nov 12, 2023
Anticipated Primary Completion Date :
Dec 12, 2023
Anticipated Study Completion Date :
Jan 30, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Plasma insulin responses over 120 minutes after consumption of the ice creams. [8 months]

  2. CGM monitor readouts over 24 hours after consumption of the ice creams. [8 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ebaa Al Ozairi Kuwait City Dasman Kuwait 15462

Sponsors and Collaborators

  • Dasman Diabetes Institute

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr. Ebaa Al Ozairi, CMO, Dasman Diabetes Institute
ClinicalTrials.gov Identifier:
NCT06135935
Other Study ID Numbers:
  • RA HM 2023-002
First Posted:
Nov 18, 2023
Last Update Posted:
Nov 18, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dr. Ebaa Al Ozairi, CMO, Dasman Diabetes Institute
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 18, 2023