NCT00978900

Brief Summary

The purpose of this study is to examine the influence of artificial sweeteners (aspartame, acesulfame K, sucralose) and carbohydrate sugars (glucose, fructose) on the release of gastrointestinal satiety hormones in humans.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Dec 2008

Typical duration for phase_1 healthy

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

December 1, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 17, 2009

Completed
Last Updated

September 17, 2009

Status Verified

September 1, 2009

Enrollment Period

3 months

First QC Date

September 16, 2009

Last Update Submit

September 16, 2009

Conditions

Healthy

Keywords

satiety peptidesGLP-1PYYghrelinappetite profileSweetening Agents

Outcome Measures

Primary Outcomes (1)

  • Gastrointestinal peptide secretion

    2 hour blood sampling

Study Arms (6)

Acesulfame K

ACTIVE COMPARATOR
Dietary Supplement: Artificial sweeteners; Carbohydrate Sugars

Sucralose

ACTIVE COMPARATOR
Dietary Supplement: Artificial sweeteners; Carbohydrate Sugars

Aspartame

ACTIVE COMPARATOR
Dietary Supplement: Artificial sweeteners; Carbohydrate Sugars

Glucose

ACTIVE COMPARATOR
Dietary Supplement: Artificial sweeteners; Carbohydrate Sugars

Fructose

ACTIVE COMPARATOR
Dietary Supplement: Artificial sweeteners; Carbohydrate Sugars

Water

PLACEBO COMPARATOR
Dietary Supplement: Water

Interventions

Artificial sweeteners; Carbohydrate SugarsDIETARY_SUPPLEMENT

sweetening agent dissolved in tap water, administered via intragastric tube

Acesulfame KAspartameFructoseGlucoseSucralose
WaterDIETARY_SUPPLEMENT
Water

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy subject with a body-mass index of 19.0-24.5
  • Normal eating habits
  • Age 18-40 years
  • Stable body weight for at least three months

You may not qualify if:

  • Smoking
  • Substance abuse
  • Regular intake of medications (except for oral contraceptives)
  • Medical or psychiatric illness
  • history of gastrointestinal disorders
  • food allergies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Sweetening AgentsWater

Intervention Hierarchy (Ancestors)

Flavoring AgentsFood AdditivesFood IngredientsSpecialty Uses of ChemicalsChemical Actions and UsesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesHydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Officials

  • Christoph Beglinger, MD

    Clinical Research Center, University Hospital Basel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 16, 2009

First Posted

September 17, 2009

Study Start

December 1, 2008

Primary Completion

March 1, 2009

Study Completion

July 1, 2009

Last Updated

September 17, 2009

Record last verified: 2009-09