NCT01088841

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Apr 2009

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

April 1, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

March 16, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 17, 2010

Completed
Last Updated

February 23, 2011

Status Verified

February 1, 2011

Enrollment Period

9 months

First QC Date

March 16, 2010

Last Update Submit

February 22, 2011

Conditions

Appetite and General Nutritional DisordersHormone Replacement

Outcome Measures

Primary Outcomes (1)

  • Gastrointestinal peptide secretion

    2 hours blood sampling

Study Arms (4)

75 g glucose + 150 ppm lactisole

ACTIVE COMPARATOR
Dietary Supplement: lactisole

75 g glucose + 300 ppm lactisole

ACTIVE COMPARATOR
Dietary Supplement: lactisole

75 g glucose + 450 ppm lactisole

ACTIVE COMPARATOR
Dietary Supplement: lactisole

75 g glucose

PLACEBO COMPARATOR
Dietary Supplement: lactisole

Interventions

lactisoleDIETARY_SUPPLEMENT

lactisole (flavoring agent/sweet taste antagonist) dissolved with 75 g glucose in 300 mL tap water; administered via intragastric tube

Also known as: Glucose, water
75 g glucose75 g glucose + 150 ppm lactisole75 g glucose + 300 ppm lactisole75 g glucose + 450 ppm lactisole

Eligibility Criteria

Age18 Years - 40 Years
Sexall
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, Clinical Research Center

Basel, 4031, Switzerland

Location

MeSH Terms

Interventions

lactisoleGlucoseWater

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydratesHydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Officials

  • Christoph Beglinger, MD

    Clinical Research Center, 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

Study Record Dates

First Submitted

March 16, 2010

First Posted

March 17, 2010

Study Start

April 1, 2009

Primary Completion

January 1, 2010

Study Completion

March 1, 2010

Last Updated

February 23, 2011

Record last verified: 2011-02

Locations

CH(1)