NCT05810337

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 18, 2023

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2023

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

March 30, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 12, 2023

Completed
Last Updated

April 12, 2023

Status Verified

March 1, 2023

Enrollment Period

14 days

First QC Date

March 30, 2023

Last Update Submit

March 30, 2023

Conditions

Appetitive BehaviorGlucose Metabolism Disorders

Keywords

Blood glucoseAppetiteEnergy intake

Outcome Measures

Primary Outcomes (2)

  • Change in blood glucose

    Capillary blood glucose from fingerprick and measured using glucose monitor

    -5 to 180 minutes (measured from baseline up to 90min every 15min and from 90-180min every 30min)

  • Change in appetite

    Feelings of hunger, desire to eat, fullness and alertness measured using Visual Analogue Scale (VAS)

    -5 to 180 minutes (measured from baseline up to 90min every 15min and from 90-180min every 30min)

Secondary Outcomes (1)

  • 24 hour energy intake

    0 - 24 hours

Study Arms (2)

Splenda drink

EXPERIMENTAL

Drink containing 4.5g Splenda dissolved on 250ml water.

Dietary Supplement: Splenda drinkDietary Supplement: High carbohydrate breakfast

Maltodextrin drink

PLACEBO COMPARATOR

Drink containing 4.5g maltodextrin dissolved on 250ml water.

Dietary Supplement: Maltodextrin drinkDietary Supplement: High carbohydrate breakfast

Interventions

Splenda drinkDIETARY_SUPPLEMENT

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

Splenda drink
Maltodextrin drinkDIETARY_SUPPLEMENT

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

Maltodextrin drink
High carbohydrate breakfastDIETARY_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 drinkSplenda drink

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King's College London

London, SE1 9NH, United Kingdom

Location

MeSH Terms

Conditions

Appetitive BehaviorGlucose Metabolism Disorders

Condition Hierarchy (Ancestors)

Behavior, AnimalBehaviorMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Christopher Corpe, Dr.

    King's College London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nutrition Sciences Lecturer, Principal investigator

Study Record Dates

First Submitted

March 30, 2023

First Posted

April 12, 2023

Study Start

January 18, 2023

Primary Completion

February 1, 2023

Study Completion

March 13, 2023

Last Updated

April 12, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)