- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02891525
The Influence of Sweet Substrates on Hunger, Gastrointestinal Hormones and the Migrating Motor Complex
September 1, 2016 updated by: Universitaire Ziekenhuizen KU Leuven
The Effect of Caloric and Non-caloric Sweeteners on Hunger, Gastrointestinal Hormones as Well as on Antral and Duodenal Motility
In this study, the investigators aimed at evaluating the role of sweet taste receptors in the gastrointestinal tract (GIT).
Intragastric administration of glucose, fructose or acesulfame-K were compared with placebo administration for their effects on gastrointestinal motility, gut hormone release (motilin, ghrelin, glucagon-like peptide-1 (GLP-1) and insulin) and hunger feelings.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Not Applicable
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 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- BMI<30 kg/m² for the lean volunteers
- Female or male subjects aged 18 to 60
- Subject is capable and willing to give informed consent
- Female volunteers of child bearing potential must use oral, injected or implanted hormonal methods of contraception
Exclusion Criteria:
- Female volunteer is pregnant or breastfeeding
- GI diseases, major abdominal surgery
- Volunteers that have food allergies, especially fructose intolerance
- Major psychiatric illnesses
- Volunteers that use drugs affecting the GI tract or the central nervous system
- Volunteers suffering from an endocrine disease such as diabetes, Cushing's disease, Addison's disease, hypothalamic tumor
- Volunteers that have undergone surgical procedure for weight loss
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: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 50g glucose intragastric
50g glucose dissolved in 250mL tap water given via nasogastric tube
|
|
Active Comparator: 25g fructose intragastric
25g glucose dissolved in 250mL tap water given via nasogastric tube
|
|
Active Comparator: 220mg acesulfame-K intragastric
220mg acesulfame-K dissolved in 250mL tap water given via nasogastric tube
|
|
Placebo Comparator: 250mL tap water intragastric
250mL tap water given via nasogastric tube
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in gastrointestinal motility measured by antroduodenal high-resolution manometry
Time Frame: 3 hours after administration, continuous measurement with high resolution manometry
|
3 hours after administration, continuous measurement with high resolution manometry
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in gut hormone release measured by specific radioactive immunoassays
Time Frame: 3 hours after administration, blood sample every 15 min
|
3 hours after administration, blood sample every 15 min
|
Change in subjective hunger and satiety scores measured by visual analogue scales of 100 mm
Time Frame: 3 hours after administration, assessment every 5 min
|
3 hours after administration, assessment every 5 min
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jan Tack, Prof., Universitaire Ziekenhuizen KU Leuven
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
March 1, 2015
Primary Completion (Actual)
February 1, 2016
Study Registration Dates
First Submitted
September 1, 2016
First Submitted That Met QC Criteria
September 1, 2016
First Posted (Estimate)
September 7, 2016
Study Record Updates
Last Update Posted (Estimate)
September 7, 2016
Last Update Submitted That Met QC Criteria
September 1, 2016
Last Verified
June 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- GIMotilitySweetTaste
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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