NCT01674946

Brief Summary

The purpose of this study is do determine the functional significance of the G protein-coupled receptor TGR5 in the secretion of GI satiation peptides by using natural bile acids and oleanolic acid (triterpenoid compound of plant origin) as TGR5 agonists.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2011

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

September 1, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 29, 2012

Completed
Last Updated

August 29, 2012

Status Verified

August 1, 2012

Enrollment Period

3 months

First QC Date

August 24, 2012

Last Update Submit

August 24, 2012

Conditions

Echolocation

Keywords

GI-physiologyCDCAbile acidsTGR5satiation peptides

Outcome Measures

Primary Outcomes (1)

  • Gastrointestinal satiation peptide secretion

    Assessment of plasma GLP-1, PYY and CCK release to BA and OA stimulation

    3 hours blood sampling

Secondary Outcomes (3)

  • Serum bile acids

    3 hours blood sampling

  • Appetite perceptions during 3 hours using visual analogue scales

    3 hours

  • Glucose and insulin secretion

    3 hours blood sampling

Study Arms (6)

ID saline

PLACEBO COMPARATOR

ID saline by feeding tube

Other: saline

ID saline + CDCA (5 mmol/L)

ACTIVE COMPARATOR

CDCA = chenodeoxycholic acid (primary bile acid)

Other: salineOther: bile acid (CDCA, chenodeoxycholic acid)

ID + CDCA (15 mmol/L)

ACTIVE COMPARATOR

CDCA = chenodeoxycholic acid (primary bile acid)

Other: salineOther: bile acid (CDCA, chenodeoxycholic acid)

ID saline + oleanolic acid (1 mmol/L)

ACTIVE COMPARATOR
Other: salineOther: oleanolic acid

ID saline + CDCA (5 mmol/L) + oleic acid

ACTIVE COMPARATOR
Other: salineOther: bile acid (CDCA, chenodeoxycholic acid)Dietary Supplement: oleic acid

ID saline + oleic acid (20 mmol/L)

PLACEBO COMPARATOR
Other: salineDietary Supplement: oleic acid

Interventions

salineOTHER

intraduodenal perfusion

ID + CDCA (15 mmol/L)ID salineID saline + CDCA (5 mmol/L)ID saline + CDCA (5 mmol/L) + oleic acidID saline + oleanolic acid (1 mmol/L)ID saline + oleic acid (20 mmol/L)
bile acid (CDCA, chenodeoxycholic acid)OTHER

intraduodenal perfusion

Also known as: primary bile acid
ID + CDCA (15 mmol/L)ID saline + CDCA (5 mmol/L)ID saline + CDCA (5 mmol/L) + oleic acid
oleanolic acidOTHER

intraduodenal perfusion

Also known as: triterpenoid compound of plant origin
ID saline + oleanolic acid (1 mmol/L)
oleic acidDIETARY_SUPPLEMENT

intraduodenal perfusion

Also known as: fatty acid
ID saline + CDCA (5 mmol/L) + oleic acidID saline + oleic acid (20 mmol/L)

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 months

You may not qualify if:

  • Smoking
  • Substance abuse
  • Regular intake of medication
  • Medical of 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

Echolocation

Interventions

Sodium ChlorideBile Acids and SaltsChenodeoxycholic AcidOleanolic AcidOleic AcidFatty Acids

Condition Hierarchy (Ancestors)

Animal CommunicationBehavior, AnimalBehavior

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsSteroidsFused-Ring CompoundsPolycyclic CompoundsDeoxycholic AcidCholic AcidsCholanesPentacyclic TriterpenesTriterpenesTerpenesHydrocarbonsOrganic ChemicalsSapogeninsOleic AcidsFatty Acids, MonounsaturatedFatty Acids, UnsaturatedLipids

Study Officials

  • Christoph Beglinger, MD

    University Hospital Basel, Phase 1 Research Unit, Basel Switzerland

    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

August 24, 2012

First Posted

August 29, 2012

Study Start

September 1, 2011

Primary Completion

December 1, 2011

Study Completion

May 1, 2012

Last Updated

August 29, 2012

Record last verified: 2012-08

Locations

CH(1)