NCT03075371

Brief Summary

The goal of the present study is to investigate metabolic gut-brain signaling and the neural correlates of distraction from visual food cues in patients with Anorexia nervosa and healthy controls.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2014

Longer than P75 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

September 1, 2014

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

February 28, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 9, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

October 3, 2019

Status Verified

October 1, 2019

Enrollment Period

4.3 years

First QC Date

February 28, 2017

Last Update Submit

October 2, 2019

Conditions

Anorexia NervosaHealthy

Outcome Measures

Primary Outcomes (2)

  • Resting state brain activity using fMRI

    Functional brain imaging will be employed to assess metabolic gut-brain signaling during a single blind, randomized cross-over design of gastric glucose vs. water infusion.

    35 min

  • Experimental fMRI task

    Participants will be asked to either view food or nonfood images or to down-regulate their emotional response by distracting themselves from the stimuli by solving an arithmetic task.

    20 min

Secondary Outcomes (2)

  • Analysis of hormonal satiety signaling

    30 min before scanning, 30 min after intragastric feeding, 60 min after intragastric feeding

  • Self-report questionnaire regarding eating behavior (Dutch Eating Behavior Questionnaire)

    30 min

Study Arms (2)

intragastric glucose administration

ACTIVE COMPARATOR
Other: Glucose

intragastric water administration

PLACEBO COMPARATOR
Other: Placebo

Interventions

GlucoseOTHER

75 g of glucose dissolved in 300 ml of water

intragastric glucose administration
PlaceboOTHER

300 ml of tap water

intragastric water administration

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients that meet the diagnostic criteria for AN (DSM-V criteria)
  • Medically stable patients with a BMI \< 17.5 kg/m² and \> 13 kg/m²; Healthy controls with a BMI \<25 kg/m² and \>18.5 kg/m²
  • Over Age of 18 years
  • no other lifetimes or current medical illness that could potentially affect appetite or body weight
  • right-handedness
  • normal or corrected-to-normal vision

You may not qualify if:

  • history of head injury or surgery
  • history of neurological disorder
  • severe psychiatric comorbidity (psychosis, bipolar disorder, substance abuse)
  • smoking
  • borderline personality disorder
  • current psychotropic medication
  • inability to undergo fMRI scanning (e.g. metallic implants, claustrophobia, Pacemakers)
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Heidelberg

Heidelberg, Germany

Location

Related Publications (3)

  • Stopyra MA, Friederich HC, Lavandier N, Monning E, Bendszus M, Herzog W, Simon JJ. Homeostasis and food craving in obesity: a functional MRI study. Int J Obes (Lond). 2021 Nov;45(11):2464-2470. doi: 10.1038/s41366-021-00920-4. Epub 2021 Aug 17.

    PMID: 34404907DERIVED

  • Stopyra MA, Friederich HC, Monning E, Lavandier N, Bendszus M, Herzog W, Simon JJ. The influence of homeostatic mechanisms on neural regulation of food craving in anorexia nervosa. Psychol Med. 2021 Apr;51(6):1011-1019. doi: 10.1017/S0033291719003970. Epub 2020 Jan 14.

    PMID: 31931900DERIVED

  • Stopyra MA, Friederich HC, Sailer S, Pauen S, Bendszus M, Herzog W, Simon JJ. The effect of intestinal glucose load on neural regulation of food craving. Nutr Neurosci. 2021 Feb;24(2):109-118. doi: 10.1080/1028415X.2019.1600275. Epub 2019 Apr 15.

    PMID: 30983543DERIVED

MeSH Terms

Conditions

Anorexia Nervosa

Interventions

Glucose

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydrates

Study Officials

  • Joe Simon, Dr. Dipl. Psych.

    University Hospital Heidelberg

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 28, 2017

First Posted

March 9, 2017

Study Start

September 1, 2014

Primary Completion

December 1, 2018

Study Completion

February 1, 2019

Last Updated

October 3, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)