NCT02891525

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable healthy

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 7, 2016

Completed
Last Updated

September 7, 2016

Status Verified

June 1, 2016

Enrollment Period

11 months

First QC Date

September 1, 2016

Last Update Submit

September 1, 2016

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Change in gastrointestinal motility measured by antroduodenal high-resolution manometry

    3 hours after administration, continuous measurement with high resolution manometry

Secondary Outcomes (2)

  • 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

Study Arms (4)

50g glucose intragastric

ACTIVE COMPARATOR

50g glucose dissolved in 250mL tap water given via nasogastric tube

Dietary Supplement: 50g glucose

25g fructose intragastric

ACTIVE COMPARATOR

25g glucose dissolved in 250mL tap water given via nasogastric tube

Dietary Supplement: 25g fructose

220mg acesulfame-K intragastric

ACTIVE COMPARATOR

220mg acesulfame-K dissolved in 250mL tap water given via nasogastric tube

Dietary Supplement: 220mg acesulfame-K

250mL tap water intragastric

PLACEBO COMPARATOR

250mL tap water given via nasogastric tube

Dietary Supplement: 250mL tap water

Interventions

50g glucoseDIETARY_SUPPLEMENT
50g glucose intragastric
25g fructoseDIETARY_SUPPLEMENT
25g fructose intragastric
220mg acesulfame-KDIETARY_SUPPLEMENT
220mg acesulfame-K intragastric
250mL tap waterDIETARY_SUPPLEMENT
250mL tap water intragastric

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Meyer-Gerspach AC, Biesiekierski JR, Deloose E, Clevers E, Rotondo A, Rehfeld JF, Depoortere I, Van Oudenhove L, Tack J. Effects of caloric and noncaloric sweeteners on antroduodenal motility, gastrointestinal hormone secretion and appetite-related sensations in healthy subjects. Am J Clin Nutr. 2018 May 1;107(5):707-716. doi: 10.1093/ajcn/nqy004.

    PMID: 29722834DERIVED

MeSH Terms

Interventions

GlucoseFructoseacetosulfame

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydratesKetoses

Study Officials

  • Jan Tack, Prof.

    Universitaire Ziekenhuizen KU Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2016

First Posted

September 7, 2016

Study Start

March 1, 2015

Primary Completion

February 1, 2016

Last Updated

September 7, 2016

Record last verified: 2016-06