The Acute Effect of D-allulose Consumption on Postprandial Glycaemia

NCT06330636 | Completed

• 1 other identifier: 336-0723
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The rare sugar D-Allulose, when consumed in a drink before eating has been shown to reduce the blood glucose response to high carbohydrate drinks or meals in people who are healthy, or have elevated fasting blood glucose concentration. However, the effectiveness of D-allulose to suppress blood glucose concentration when added into carbohydrate containing food products has not been previously reported and as the potential use of allulose is as a sucrose replacer in foods, rather than drinks, it is important that effects and efficacy are tested in this format. The study aimed to extend understanding of the acute effects of D-allulose consumption in humans by testing whether post-eating blood glucose concentration can be modified by the presence of D-allulose in a high carbohydrate breakfast and collecting data on any adverse gastrointestinal effects of consuming D-allulose.

Conditions

Sugar; Blood, High

Keywords

glycaemia response; D-allulose; dietary carbohydrates

Outcome Measures

Primary Outcomes (2)

• Incremental area under the curve (iAUC) 180 Glucose Test

  Incremental area under the curve (180min) for blood glucose on test day

  180 minutes after breakfast ingestion

• iAUC 180 Glucose Placebo

  Incremental area under the curve (180min) for blood glucose on placebo day

  180 minutes after breakfast ingestion

Secondary Outcomes (15)

• Glycaemia Test

  180 minutes after breakfast ingestion

• Glycaemia Placebo

  180 minutes after breakfast ingestion

• Insulinemia Test

  180 minutes after breakfast ingestion

• Insulinemia Placebo

  180 minutes after breakfast ingestion

• iAUC 180 Insulin Test

  180 minutes after breakfast ingestion

Study Arms (2)

D-Allulose

EXPERIMENTAL

15g D-Allulose added to a high glycaemic index oat porridge

Other: D-Allulose

Saccharin

PLACEBO COMPARATOR

Sodium saccharin (1x 'Sweetex' tablet) added to a high glycaemic index oat porridge

Other: Sodium Saccharin

Interventions

D-Allulose OTHER

Test breakfast

Also known as: Test Day

D-Allulose

Sodium Saccharin OTHER

placebo breakfast

Also known as: Control Day

Saccharin

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participant is willing and able to give informed consent for participation in the study
• Not currently taking any medications (using contraceptive medication is acceptable)
• Aged between 18 and 40 years
• Healthy weight or overweight (Body Mass Index 19-30 kg/m2)

You may not qualify if:

• Reporting functional gastrointestinal problems, such as irritable bowel syndrome, gastroparesis or reflux
• History of inflammatory bowel diseases such as Crohn's disease or Ulcerative colitis
• Diabetes mellitus
• Surgical resection of gastrointestinal tract.
• Food allergies, intolerances or acceptability issues related to the standard meal, including veganism, lactose intolerance and coeliac disease.
• Following a restricted habitual diet e.g. low carbohydrate, high protein or meal replacement diet
• Following a restrictive dietary pattern e.g. intermittent fasting
• Currently following a reduced-energy diet to control body weight
• Pregnant or breast feeding
• History or current psychiatric illness
• History or current neurological condition (e.g. epilepsy)
• Taking regular medication, including over the counter and prescription drugs; Oral contraception medication and intermittent use of over the counter pain relief is acceptable.
• Having taken part in a research study in the last 3 months involving invasive procedures or an inconvenience allowance

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (1)

David Greenfield Human Physiology Laboratories

Nottingham, Notts, NG72UH, United Kingdom

Location

MeSH Terms

Conditions

Hyperglycemia

Interventions

Saccharin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Benzothiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Liz Simpson, PhD

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Allocation coded A and B, with independent researcher determining allocation and making up the test breakfasts for the study team.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomised, placebo controlled cross over design

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: March 26, 2024
• Study Start: September 11, 2023
• Primary Completion: March 28, 2024
• Study Completion: June 24, 2024
• Last Updated: June 25, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Once published in the public domain. Availability will be for a period of 7 years from publication, after which time all data will be destroyed
• Access Criteria: Access will be subject to ethical constraints, the preservation of intellectual property (IP), and written acknowledgement that it is a research collaboration, with data ownership residing with the original research teams.

Locations

GB (1)