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Completed

NCT Number: NCT02891525

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

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.

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Key information

Conditions

Healthy

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

50g glucose

Dietary Supplement

25g fructose

Dietary Supplement

220mg acesulfame-K

Dietary Supplement

250mL tap water

Dietary Supplement

Primary outcomes

  1. Change in gastrointestinal motility measured by antroduodenal high-resolution manometry

    Time frame: 3 hours after administration, continuous measurement with high resolution manometry

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
First posted
Sep 7, 2016
Registry last updated
Sep 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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