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

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of Caloric and Non-caloric Sweeteners on Hunger, Gastrointestinal Hormones as Well as on Antral and Duodenal Motility

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: 50g glucose
* Dietary Supplement: 25g fructose
* Dietary Supplement: 220mg acesulfame-K
* Dietary Supplement: 250mL tap water


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 50g glucose intragastric<br>50g glucose dissolved in 250mL tap water given via nasogastric tube | Dietary Supplement: 50g glucose<br> <br> |
| Active Comparator: 25g fructose intragastric<br>25g glucose dissolved in 250mL tap water given via nasogastric tube | Dietary Supplement: 25g fructose<br> <br> |
| Active Comparator: 220mg acesulfame-K intragastric<br>220mg acesulfame-K dissolved in 250mL tap water given via nasogastric tube | Dietary Supplement: 220mg acesulfame-K<br> <br> |
| Placebo Comparator: 250mL tap water intragastric<br>250mL tap water given via nasogastric tube | Dietary Supplement: 250mL tap water<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in gastrointestinal motility measured by antroduodenal high-resolution manometry |  | 3 hours after administration, continuous measurement with high resolution manometry | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in gut hormone release measured by specific radioactive immunoassays |  | 3 hours after administration, blood sample every 15 min | 
| Change in subjective hunger and satiety scores measured by visual analogue scales of 100 mm |  | 3 hours after administration, assessment every 5 min |