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Effects of Consuming Artificial Sweeteners and Sugar on Cerebral and Physiological Responses (SUGART)

24. oktober 2017 opdateret af: Luc Tappy, MD, University of Lausanne

Acute Effects of Artificial Sweeteners and Sugar on the Brain Dynamics to Food Image Viewing. An Exploratory, Monocentric, Randomized Controlled Trial in Healthy Young Men

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.

Studieoversigt

Detaljeret beskrivelse

This study is made on a randomized controlled crossover design including three conditions (water, sugar, artificial sweeteners). Measurements will be performed in fasting and fed conditions. The test-meal will comprise either an artificially or sugar-sweetened beverage or water (control). The spatio-temporal brain dynamics to the viewing of food pictures will be assessed by means of electroencephalography (EEG) recordings and electrical neuroimaging analyses. Venous blood and urine will be collected. Blood pressure, cardiac frequency and bio-impedance measurements will be performed. Food intake behavior will be assessed by means of questionnaires and a free-choice buffet. Each tested condition (water, sugar, artificial sweeteners) will be preceded by a run-in period during which the participants' diet will be controlled (2-day isoenergetic diet).

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

18

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Vaud
      • Lausanne, Vaud, Schweiz, 1005
        • Department of Physiology

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 40 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Han

Beskrivelse

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Artificial sweetener
Effects of co-ingestion of artificially sweetened beverage on the response to a test meal
participants will ingest a test meal containing 55% carbohydrate, 30% fat and 15% protein with artificially sweetened drinks
participants will ingest a test meal containing 55% carbohydrate, 30% fat and 15% protein with sugary drinks drinks
Aktiv komparator: Sugar
Effects of co-ingestion of sugar-sweetened beverage on the response to a test meal
participants will ingest a test meal containing 55% carbohydrate, 30% fat and 15% protein with artificially sweetened drinks
participants will ingest a test meal containing 55% carbohydrate, 30% fat and 15% protein with sugary drinks drinks
Aktiv komparator: Water
Effects of co-ingestion of water on the response to a test meal
participants will ingest a test meal containing 55% carbohydrate, 30% fat and 15% protein with waters

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Spatio-temporal brain dynamics
Tidsramme: differences observed between 60 min before and 60 min after ingestion of a test meal
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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Changes in concentration of blood insulin
Tidsramme: -120 min before ingestion of a test meal, and 30, 60, 90, 150, and 210 min after ingestion of a test meal
Blood substrate concentration will be measured in fasting conditions and after ingestion of a test meal
-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
Tidsramme: -120 min before ingestion of a test meal, and 30, 60, 90, 150, and 210 min after ingestion of a test meal
Blood substrate concentration will be measured in fasting conditions and after ingestion of a test meal
-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
Tidsramme: -120 min before ingestion of a test meal, and 30, 60, 90, 150, and 210 min after ingestion of a test meal
Blood substrate concentration will be measured in fasting conditions and after ingestion of a test meal
-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
Tidsramme: 240 min after ingestion of a test meal
Food intake behavior will be assessed by monitoring spontaneous food intake when offered a free-choice buffet.
240 min after ingestion of a test meal

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Luc Tappy, Professor, Department of Physiology, University of Lausanne, Switzerland

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. februar 2016

Primær færdiggørelse (Faktiske)

29. september 2017

Studieafslutning (Faktiske)

29. september 2017

Datoer for studieregistrering

Først indsendt

8. februar 2016

Først indsendt, der opfyldte QC-kriterier

29. juli 2016

Først opslået (Skøn)

3. august 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. oktober 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. oktober 2017

Sidst verificeret

1. juli 2016

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 353/15

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Normale emner

Kliniske forsøg med ingestion of a test meal with sweetener

Abonner