NCT02745730

Brief Summary

Resting state functional magnetic resonance imaging (rsfMRl) of the brain is used to measure pleasantness after consumption of four different milkshakes with added sugars or sweeteners.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2016

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

March 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 4, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 20, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

November 21, 2016

Status Verified

November 1, 2016

Enrollment Period

3 months

First QC Date

April 4, 2016

Last Update Submit

November 18, 2016

Conditions

Pleasure

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in the connectivity in the default mode and salience network: glucose and fructose vs. sucralose and allulose.

    Six minutes before (baseline) and 12 minutes after (response) test product intake

Secondary Outcomes (2)

  • 2. Change from baseline in the connectivity in the default mode and salience network: glucose vs. fructose.

    Six minutes before (baseline) and 12 minutes after (response) test product intake

  • 3. Change from baseline in the connectivity in the default mode and salience network: allulose vs. sucralose.

    Six minutes before (baseline) and 12 minutes after (response) test product intake

Other Outcomes (2)

  • 4. Change from baseline in the connectivity in the default mode and salience network: glucose vs allulose; glucose vs sucralose; fructose vs sucralose and fructose vs allulose.

    Six minutes before (baseline) and 12 minutes after (response) test product intake

  • Changes from baseline in the BOLD signal

    Six minutes before (baseline) and 12 minutes after (response) test product intake

Study Arms (4)

Glucose

ACTIVE COMPARATOR

Shake sweetened with glucose

Other: Glucose

Fructose

ACTIVE COMPARATOR

Shake sweetened with fructose

Other: Fructose

Sucralose

EXPERIMENTAL

Shake sweetened with sucralose

Other: Sucralose

Allulose

EXPERIMENTAL

Shake sweetened with allulose

Other: Allulose

Interventions

GlucoseOTHER
Glucose
FructoseOTHER
Fructose
SucraloseOTHER
Sucralose
AlluloseOTHER
Allulose

Eligibility Criteria

Age18 Years - 25 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Signed informed consent
  • Age between 18 and 25 years
  • BMI between 20 and 23 kg/m2
  • Weight above 70 kg
  • Length between 170 and 190 centimetres

You may not qualify if:

  • Diabetes or history of other disturbances of glucose metabolism (eg impaired glucose tolerance, hypoglycaemia).
  • Any genetic or psychiatric disease (e.g. fragile X syndrome, major depression) affecting brain
  • Any know food allergy or intolerance
  • Any significant chronic disease
  • Renal or hepatic disease
  • Recent weight changes or attempts to lose weight (\> 3 kg weight gain or loss, within the last 3 months)
  • Smoking (current or last 6 months)
  • Alcohol consumption of more than 21 units per week or use of recreational drugs at present or in the last year
  • Recent blood donation (within the last 2 months)
  • Recent participation in other biomedical research projects (within the last 3 months), participation in 3 or more biomedical research projects in one year
  • Contra-indication to MRI scanning:
  • Claustrophobia
  • Pacemakers and defibrillators
  • Nerve stimulators
  • Intracranial clips
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leids Universitair Medisch Centrum

Leiden, South Holland, Netherlands

Location

Related Publications (2)

  • Lodi A, Zarantonello L, Bisiacchi PS, Cenci L, Paoli A. Ketonemia and Glycemia Affect Appetite Levels and Executive Functions in Overweight Females During Two Ketogenic Diets. Obesity (Silver Spring). 2020 Oct;28(10):1868-1877. doi: 10.1002/oby.22934. Epub 2020 Sep 1.

    PMID: 32875733DERIVED

  • Van Opstal AM, Hafkemeijer A, van den Berg-Huysmans AA, Hoeksma M, Mulder TPJ, Pijl H, Rombouts SARB, van der Grond J. Brain activity and connectivity changes in response to nutritive natural sugars, non-nutritive natural sugar replacements and artificial sweeteners. Nutr Neurosci. 2021 May;24(5):395-405. doi: 10.1080/1028415X.2019.1639306. Epub 2019 Jul 10.

    PMID: 31288630DERIVED

MeSH Terms

Interventions

GlucoseFructosetrichlorosucrosepsicose

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydratesKetoses

Study Officials

  • Jeroen van der Grond, Dr.

    Leiden University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2016

First Posted

April 20, 2016

Study Start

March 1, 2016

Primary Completion

June 1, 2016

Study Completion

October 1, 2016

Last Updated

November 21, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)