NCT02589613

Brief Summary

The objective is to investigate neuro-anatomical correlates of the regulation of energy intake by means of functional MRI. Administration of glucose as well as fructose is followed by functional brain MRI, and findings are correlated with serum glucagon-like peptide 1 (GLP-1) levels as an endogenous satiety signal in obese humans.

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

Timeline
Completed

Started Oct 2013

Shorter than P25 for not_applicable

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

October 1, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 20, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 28, 2015

Completed
Last Updated

October 28, 2015

Status Verified

October 1, 2015

Enrollment Period

8 months

First QC Date

October 20, 2015

Last Update Submit

October 26, 2015

Conditions

Exploratory Behavior

Outcome Measures

Primary Outcomes (1)

  • Functional magnetic resonance imaging (fMRI) in healthy, obese volunteers while they performed a working memory task: changes in cerebral blood flow

    changes from baseline to one hour after treatment

Secondary Outcomes (3)

  • Changes in plasma insulin

    changes from baseline to one hour after treatment

  • Changes in plasma glucose

    changes from baseline to one hour after treatment

  • Changes in plasma GLP-1

    changes from baseline to one hour after treatment

Study Arms (3)

PLACEBO

PLACEBO COMPARATOR

Single intragastric instillation of 300ml tap water via nasogastric tube

Dietary Supplement: tap water

GLUCOSE

ACTIVE COMPARATOR

Single intragastric instillation of 75g Glucose in 300ml tap water via nasogastric tube

Dietary Supplement: Glucose

FRUCTOSE

ACTIVE COMPARATOR

Single intragastric instillation of 25g Fructose in 300ml tap water via nasogastric tube

Dietary Supplement: Fructose

Interventions

tap waterDIETARY_SUPPLEMENT

300ml tap water via nasogastric tube

PLACEBO
GlucoseDIETARY_SUPPLEMENT

300ml tap water with 75g Glucose via nasogastric tube

GLUCOSE
FructoseDIETARY_SUPPLEMENT

300ml tap water with 25g Fructose via nasogastric tube

FRUCTOSE

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • right-handed healthy males, no drugs, non-smoking

You may not qualify if:

  • drug abuse, smoker, left-handed, claustrophobia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Exploratory Behavior

Interventions

GlucoseFructose

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydratesKetoses

Study Officials

  • Christoph Beglinger, MD

    University of Basel

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2015

First Posted

October 28, 2015

Study Start

October 1, 2013

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

October 28, 2015

Record last verified: 2015-10