NCT02853773

Brief Summary

This study aims at investigating the acute influence of artificially sweetened beverages consumption (as compared with sugar-sweetened beverages and water consumption) on brain responses to the viewing of food images, on physiological responses (gut-derived hormones and lipid metabolites) and on the food intake behavior.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2016

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

February 8, 2016

Completed
6 months until next milestone

First Posted

Study publicly available on registry

August 3, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2017

Completed
Last Updated

October 26, 2017

Status Verified

July 1, 2016

Enrollment Period

1.7 years

First QC Date

February 8, 2016

Last Update Submit

October 24, 2017

Conditions

Normal Subjects

Keywords

sweetenerssugarEEGfood viewingfood intake

Outcome Measures

Primary Outcomes (1)

  • Spatio-temporal brain dynamics

    Spatio-temporal brain dynamics to the viewing of food will be assessed by means of electroencephalography recordings.

    differences observed between 60 min before and 60 min after ingestion of a test meal

Secondary Outcomes (4)

  • Changes in concentration of blood insulin

    -120 min before ingestion of a test meal, and 30, 60, 90, 150, and 210 min after ingestion of a test meal

  • Changes in concentration of blood triglyceride

    -120 min before ingestion of a test meal, and 30, 60, 90, 150, and 210 min after ingestion of a test meal

  • Changes in concentration of blood Fibroblast Growth Factor (FGF)-21

    -120 min before ingestion of a test meal, and 30, 60, 90, 150, and 210 min after ingestion of a test meal

  • spontaneous food intake

    240 min after ingestion of a test meal

Study Arms (3)

Artificial sweetener

EXPERIMENTAL

Effects of co-ingestion of artificially sweetened beverage on the response to a test meal

Other: ingestion of a test meal with sweetener

Sugar

ACTIVE COMPARATOR

Effects of co-ingestion of sugar-sweetened beverage on the response to a test meal

Other: ingestion of a test meal with sweetener

Water

ACTIVE COMPARATOR

Effects of co-ingestion of water on the response to a test meal

Other: ingestion of a test meal with water

Interventions

ingestion of a test meal with sweetenerOTHER

participants will ingest a test meal containing 55% carbohydrate, 30% fat and 15% protein with artificially sweetened drinks

Artificial sweetener
ingestion of a test meal with waterOTHER

participants will ingest a test meal containing 55% carbohydrate, 30% fat and 15% protein with waters

Water

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy
  • Caucasian
  • Right-handed
  • Weak to normal physical activity (\< 3hours per week)
  • Normal-weight (19\<BMI\<25 kg/m2)
  • Regular consumption of sugar-sweetened beverages (\>33cl per week)

You may not qualify if:

  • Consumption of artificially sweetened beverages exceeding 33cl per week
  • Diabetes
  • Cardiovascular, kidney, hepatic and/or psychological disorders
  • Blood pressure at rest \> 140/90mmHg
  • Body weight \< 50kg
  • Hemoglobin \< 13.5g/dl
  • Ferritin \< 50microg/l
  • Drug consumption
  • Alcohol consumption (\>10g/day)
  • Smoking
  • Any particular diet (e.g. vegetarianism), food allergy and/or intolerance
  • Body weight gain or loss of \>3kg during the last 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Physiology

Lausanne, Canton of Vaud, 1005, Switzerland

Location

MeSH Terms

Interventions

Sweetening AgentsWater

Intervention Hierarchy (Ancestors)

Flavoring AgentsFood AdditivesFood IngredientsSpecialty Uses of ChemicalsChemical Actions and UsesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesHydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Officials

  • Luc Tappy, Professor

    Department of Physiology, University of Lausanne, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full professor

Study Record Dates

First Submitted

February 8, 2016

First Posted

August 3, 2016

Study Start

February 1, 2016

Primary Completion

September 29, 2017

Study Completion

September 29, 2017

Last Updated

October 26, 2017

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)