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The Influence of Sweet Substrates on Hunger, Gastrointestinal Hormones and the Migrating Motor Complex

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ClinicalTrials.gov Identifier: NCT02891525
Recruitment Status : Completed
First Posted : September 7, 2016
Last Update Posted : September 7, 2016
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: 50g glucose Dietary Supplement: 25g fructose Dietary Supplement: 220mg acesulfame-K Dietary Supplement: 250mL tap water Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Effect of Caloric and Non-caloric Sweeteners on Hunger, Gastrointestinal Hormones as Well as on Antral and Duodenal Motility
Study Start Date : March 2015
Actual Primary Completion Date : February 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

Arm Intervention/treatment
Active Comparator: 50g glucose intragastric
50g glucose dissolved in 250mL tap water given via nasogastric tube
Dietary Supplement: 50g glucose
Active Comparator: 25g fructose intragastric
25g glucose dissolved in 250mL tap water given via nasogastric tube
Dietary Supplement: 25g fructose
Active Comparator: 220mg acesulfame-K intragastric
220mg acesulfame-K dissolved in 250mL tap water given via nasogastric tube
Dietary Supplement: 220mg acesulfame-K
Placebo Comparator: 250mL tap water intragastric
250mL tap water given via nasogastric tube
Dietary Supplement: 250mL tap water



Primary Outcome Measures :
  1. Change in gastrointestinal motility measured by antroduodenal high-resolution manometry [ Time Frame: 3 hours after administration, continuous measurement with high resolution manometry ]

Secondary Outcome Measures :
  1. Change in gut hormone release measured by specific radioactive immunoassays [ Time Frame: 3 hours after administration, blood sample every 15 min ]
  2. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02891525


Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
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Principal Investigator: Jan Tack, Prof. Universitaire Ziekenhuizen Leuven
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT02891525    
Other Study ID Numbers: GIMotilitySweetTaste
First Posted: September 7, 2016    Key Record Dates
Last Update Posted: September 7, 2016
Last Verified: June 2016