Splenda: Effects on Blood Glucose Concentration, Appetite Scores and Subsequent Energy Intake

NCT ID: NCT05810337

Last Updated: 2023-04-12

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-18

Study Completion Date

2023-03-13

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study investigates the effects of Splenda, an artificial sweetener powder containing sucralose, on post-prandial blood glucose levels, appetite scores and subsequent energy intake.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Participants are randomly assigned to receive either the placebo drink (4.5g maltodextrin dissolved in 250ml water) or the Splenda drink (4.5g Splenda dissolved in 250ml water) taken alongside a high calorie breakfast.

Blood glucose measurements will be obtained through finger-pricking and appetite will be measured using self-reported visual analogue scores rating hunger, desire to eat, fullness and alertness for up to 3 hours after breakfast. Energy intake will be measured using a 24 hour food diary.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Appetitive Behavior Glucose Metabolism Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Splenda drink

Drink containing 4.5g Splenda dissolved on 250ml water.

Group Type EXPERIMENTAL

Splenda drink

Intervention Type DIETARY_SUPPLEMENT

4.5g Splenda containing 1% sucralose, 95% maltodextrin, dissolved in 250ml water and consumed with a high carbohydrate breakfast.

High carbohydrate breakfast

Intervention Type DIETARY_SUPPLEMENT

Meal consisting of 30g cereal with 100ml skimmed milk, 1.5 slices white toast with 12g margarine, providing 386kcal, 61.4g carbohydrate, 10.4g protein and 10.1g fat.

Maltodextrin drink

Drink containing 4.5g maltodextrin dissolved on 250ml water.

Group Type PLACEBO_COMPARATOR

Maltodextrin drink

Intervention Type DIETARY_SUPPLEMENT

4.5g maltodextrin dissolved in 250ml water and consumed with a high carbohydrate breakfast.

High carbohydrate breakfast

Intervention Type DIETARY_SUPPLEMENT

Meal consisting of 30g cereal with 100ml skimmed milk, 1.5 slices white toast with 12g margarine, providing 386kcal, 61.4g carbohydrate, 10.4g protein and 10.1g fat.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Splenda drink

4.5g Splenda containing 1% sucralose, 95% maltodextrin, dissolved in 250ml water and consumed with a high carbohydrate breakfast.

Intervention Type DIETARY_SUPPLEMENT

Maltodextrin drink

4.5g maltodextrin dissolved in 250ml water and consumed with a high carbohydrate breakfast.

Intervention Type DIETARY_SUPPLEMENT

High carbohydrate breakfast

Meal consisting of 30g cereal with 100ml skimmed milk, 1.5 slices white toast with 12g margarine, providing 386kcal, 61.4g carbohydrate, 10.4g protein and 10.1g fat.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Healthy male and female adults (18-64 years)

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

King's College London

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dr Christopher Corpe

Nutrition Sciences Lecturer, Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Christopher Corpe, Dr.

Role: PRINCIPAL_INVESTIGATOR

King's College London

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

King's College London

London, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KCLMScNutr2023

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.