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

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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