NCT01302574

Brief Summary

The purpose of this study is to determine the functional significance of sweet taste receptors in the secretion of gastrointestinal (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
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 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

January 1, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 24, 2011

Completed
Last Updated

February 24, 2011

Status Verified

February 1, 2011

Enrollment Period

2 months

First QC Date

February 22, 2011

Last Update Submit

February 23, 2011

Conditions

Taste Disorder, Secondary, Sweet

Keywords

T1R2/T1R3gastric emptyinggutlactisolenutrient sensing

Outcome Measures

Primary Outcomes (1)

  • Gastrointestinal peptide secretion

    2 hours blood sampling

Secondary Outcomes (2)

  • Appetite perceptions

    4 hours

  • Gastric emptying rate

    4 hours

Study Arms (2)

mixed liquid meal

PLACEBO COMPARATOR

500 mL mixed liquid meal + 50 mg 13C-sodium-acetate

Dietary Supplement: lactisole

mixed liquid meal + lactisole

ACTIVE COMPARATOR

500 mL mixed liquid meal + 50 mg 13C-sodium-acetate + 450 ppm lactisole

Dietary Supplement: lactisole

Interventions

lactisoleDIETARY_SUPPLEMENT

Lactisole-liquid meal: Lactisole (450 ppm) will be mixed with a liquid meal. Liquid meal only: The comparator will be the liquid meal alone.

Also known as: Dietary supplement
mixed liquid mealmixed liquid meal + 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 years old
  • 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

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

Study Record Dates

First Submitted

February 22, 2011

First Posted

February 24, 2011

Study Start

January 1, 2010

Primary Completion

March 1, 2010

Study Completion

June 1, 2010

Last Updated

February 24, 2011

Record last verified: 2011-02

Locations

CH(1)