NCT01516021

Brief Summary

The aim of the current study was to investigate the effect of a high versus a low fat meal (operationalized by high and low fat yoghurt) on homeostatic and gustatory brain regions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2011

Shorter than P25 for not_applicable

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, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2012

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 24, 2012

Completed
Last Updated

January 24, 2012

Status Verified

January 1, 2012

Enrollment Period

2 months

First QC Date

January 9, 2012

Last Update Submit

January 18, 2012

Conditions

Fat Processing in the Brain

Keywords

Fat ingestionhypothalamusinsulafMRICBF

Outcome Measures

Primary Outcomes (1)

  • Changes in Cerebral Blood Flow due to the high or low fat yoghurt intake after 30 minutes and 120 minutes compared to a baseline measurement 30 minutes before yoghurt intake.

    We were interested in differential brain activations due to the high or low fat meal. To assess this, the mentioned time points are suitable. The Cerebral Blood Flow is measured using Arterial Spin Labeling sequences in a functional magnetic resonance tomography.

    30 minutes before as well as 30 minutes and 120 minutes after fat intake

Study Arms (2)

high fat yoghurt intake

EXPERIMENTAL

500 ml of a high fat yoghurt

Dietary Supplement: intake of high or low fat yoghurt

low fat yoghurt intake

EXPERIMENTAL
Dietary Supplement: intake of high or low fat yoghurt

Interventions

intake of high or low fat yoghurtDIETARY_SUPPLEMENT

intake of 500 ml of a high fat yoghurt on one day and intake of 500 ml of a low fat yoghurt on the other day

high fat yoghurt intakelow fat yoghurt intake

Eligibility Criteria

Age25 Years - 32 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • male
  • healthy

You may not qualify if:

  • lactose intolerance
  • fMRI contraindications (metal implants,...)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Clinic of Tuebingen, MEG Center

Tübingen, 72076, Germany

Location

Related Publications (1)

  • Frank S, Linder K, Kullmann S, Heni M, Ketterer C, Cavusoglu M, Krzeminski A, Fritsche A, Haring HU, Preissl H, Hinrichs J, Veit R. Fat intake modulates cerebral blood flow in homeostatic and gustatory brain areas in humans. Am J Clin Nutr. 2012 Jun;95(6):1342-9. doi: 10.3945/ajcn.111.031492. Epub 2012 May 9.

    PMID: 22572644DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 9, 2012

First Posted

January 24, 2012

Study Start

January 1, 2011

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

January 24, 2012

Record last verified: 2012-01

Locations

DE(1)