NCT01304823

Brief Summary

The purpose of this study is to determine the functional significance of sweet taste receptors in the secretion of GI satiation peptides by using a specific sweet taste receptor antagonist to block sweet taste perception in the gastrointestinal tract.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2010

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

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

June 1, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 25, 2011

Completed
Last Updated

July 16, 2015

Status Verified

July 1, 2015

Enrollment Period

2 months

First QC Date

February 22, 2011

Last Update Submit

July 15, 2015

Conditions

Taste Disorder, Primary, Sweet

Keywords

T1R2/T1R3gastric emptyinggutlactisolenutrient sensing

Outcome Measures

Primary Outcomes (1)

  • Gastrointestinal peptide secretion

    Assessment of venous GLP-1 and PYY release to meal stimulation with and without sweet receptor blockade

    4 hours blood sampling

Secondary Outcomes (1)

  • Appetite perceptions during 4 hours using VAS

    4 hours

Study Arms (5)

glucose

ACTIVE COMPARATOR

intraduodenal perfusion of glucose (29.3 g glucose per 100 mL; rate: 2.5 mL/min for 180 min; caloric load: 3.0 kcal/min)

Dietary Supplement: lactisole

glucose + lactisole

ACTIVE COMPARATOR

intraduodenal perfusion of glucose (29.3 g glucose per 100 mL; rate: 2.5 mL/min for 180 min; caloric load: 3.0 kcal/min) + 450 ppm lactisole

Dietary Supplement: lactisole

mixed liquid meal

ACTIVE COMPARATOR

intraduodenal perfusion of a mixed liquid meal (20.20 g carbohydrate, 4.92 g fat and 6.25 g protein per 100 mL; rate: 2.5 mL/min for 180 min; caloric load: 3.0 kcal/min)

Other: mixed liquid meal

mixed liquid meal + lactisole

ACTIVE COMPARATOR

intraduodenal perfusion of a mixed liquid meal (20.20 g carbohydrate, 4.92 g fat and 6.25 g protein per 100 mL; rate: 2.5 mL/min for 180 min; caloric load: 3.0 kcal/min) + 450 ppm lactisole

Other: mixed liquid meal

saline + lactisole

PLACEBO COMPARATOR

saline (0.9 %; rate: 2.5 mL/min for 180 min) + 450 ppm lactisole

Dietary Supplement: lactisole

Interventions

lactisoleDIETARY_SUPPLEMENT

flavoring agent/sweet taste antagonist

Also known as: Dietary supplement
glucoseglucose + lactisolesaline + lactisole
mixed liquid mealOTHER

Ensure Plus

Also known as: Dietary supplement
mixed liquid mealmixed liquid meal + lactisole

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy subjects
  • BMI of 19.0-24.5
  • Age 18-40
  • stable body weight for at least 3 month

You may not qualify if:

  • smoking
  • substance abuse
  • regular intake of medication
  • medical or psychiatric illness
  • gastrointestinal disorders or food allergies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Basel, Phase 1 Research Unit

Basel, 4031, Switzerland

Location

Related Publications (2)

  • Steinert RE, Meyer-Gerspach AC, Beglinger C. The role of the stomach in the control of appetite and the secretion of satiation peptides. Am J Physiol Endocrinol Metab. 2012 Mar 15;302(6):E666-73. doi: 10.1152/ajpendo.00457.2011. Epub 2012 Jan 3.

    PMID: 22215654RESULT

  • Steinert RE, Gerspach AC, Gutmann H, Asarian L, Drewe J, Beglinger C. The functional involvement of gut-expressed sweet taste receptors in glucose-stimulated secretion of glucagon-like peptide-1 (GLP-1) and peptide YY (PYY). Clin Nutr. 2011 Aug;30(4):524-32. doi: 10.1016/j.clnu.2011.01.007. Epub 2011 Feb 15.

    PMID: 21324568RESULT

MeSH Terms

Conditions

Taste Disorders

Interventions

lactisoleDietary Supplements

Condition Hierarchy (Ancestors)

Sensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Christoph Beglinger, MD

    Phase 1 Research Unit, University Hospital Basel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2011

First Posted

February 25, 2011

Study Start

June 1, 2010

Primary Completion

August 1, 2010

Study Completion

January 1, 2011

Last Updated

July 16, 2015

Record last verified: 2015-07

Locations

CH(1)