- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02853773
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
Status
Afsluttet
Betingelser
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.
Sponsor
Samarbejdspartnere
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
Nøgleord
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 .
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