- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00978900
Effects of Artificial Sweetener on Gastrointestinal (GI) Peptide Secretion
September 16, 2009 updated by: University Hospital, Basel, Switzerland
Carbohydrates and Non Caloric Sweeteners: Differential Effects on Appetite and Secretion of Gastrointestinal Satiety Peptide
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Artificial Sweeteners significantly lower energy density of foods and beverages.
They are used by diabetics as sugar substitutes as well as by consumers as aids for dietary control.
Despite numerous studies which show mainly no influence of artificial sweeteners on glucose metabolism and food intake, discrepancies consist about the real effects of artificial sweeteners.
Studies by Blundell and Hill in 1986 have however shown that the consumption of artificial sweeteners resulted in an increase of appetite ratings; the efficiency of AS has therefore been questioned.
With respect to the world wide increase in the prevalence in obesity, it seems important to clarify whether artificial sweeteners can help regulate body weight or not.
This study will explore the effect of artificial sweeteners on the release of the gastrointestinal satiety hormones PYY, GLP-1, GIP and ghrelin.
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Smoking
- Substance abuse
- Regular intake of medications (except for oral contraceptives)
- Medical or psychiatric illness
- history of gastrointestinal disorders
- food allergies
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Water
|
|
Active Comparator: Fructose
|
sweetening agent dissolved in tap water, administered via intragastric tube
|
Active Comparator: Acesulfame K
|
sweetening agent dissolved in tap water, administered via intragastric tube
|
Active Comparator: Sucralose
|
sweetening agent dissolved in tap water, administered via intragastric tube
|
Active Comparator: Aspartame
|
sweetening agent dissolved in tap water, administered via intragastric tube
|
Active Comparator: Glucose
|
sweetening agent dissolved in tap water, administered via intragastric tube
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Gastrointestinal peptide secretion
Time Frame: 2 hour blood sampling
|
2 hour blood sampling
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Christoph Beglinger, MD, Clinical Research Center, University Hospital Basel
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2008
Primary Completion (Actual)
March 1, 2009
Study Completion (Actual)
July 1, 2009
Study Registration Dates
First Submitted
September 16, 2009
First Submitted That Met QC Criteria
September 16, 2009
First Posted (Estimate)
September 17, 2009
Study Record Updates
Last Update Posted (Estimate)
September 17, 2009
Last Update Submitted That Met QC Criteria
September 16, 2009
Last Verified
September 1, 2009
More Information
Terms related to this study
Other Study ID Numbers
- EKBB 69/04
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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