- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02090478
The Effect of Dietary Sugar Consumption on Sweet Taste Perception
14. marts 2014 opdateret af: Paul Wise, Monell Chemical Senses Center
The purpose of the study is to determine how reducing the amount of simple sugars in the diet affects sweet taste perception. Healthy adult subjects will be assigned to either follow their usual diet, or to replace sugar calories with fats or starch.
The investigators hypothesize that eating less sugar will:
- cause foods and drinks with a given amount of sugar to taste sweeter
- cause people to prefer lower levels of sugar in foods and drinks
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
50
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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Pennsylvania
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Philadelphia, Pennsylvania, Forenede Stater, 19014
- Monell Chemical Senses Center
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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 60 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Good general heath (by self report)
- Consume at least 2 sugar-containing soft drinks/day on average)
- Able to control diet (select their own foods)
Exclusion Criteria:
- Major illness of any kind within the last six months, or any chronic illness
- Daily use of medication, except for birth control, vitamins, and aspirin
- Regularly consume non-nutritive sweeteners
- Pregnant women
- Gained or lost 10% or more of their body weight in 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: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Sham-komparator: No change in dietary sugar levels
Group met with a dietician as often as the control group to discuss diet, but the dietician gave them advice geared toward no change in dietary sugar levels
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Subjects in the control group will meet with a dietician and discuss diet records, but the dietician will not instruct the control subjects to reduce the number of calories from simple sugars in the diet
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Eksperimentel: Low sugar group
Subjects met with a dietician who discussed diet records.
After the first month (baseline, regular diet), the dietician made suggestions geared toward reducing calories from simple sugars by 40%.
This will be achieved by replacing sugar calories with complex carbohydrates and fats, while maintaining energy balance (same number of calories as the baseline month).
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All subjects followed their usual diet during month 1.
For months 2-4: sham diet intervention for the control group, 40% reduction in sugar calories for the experimental group.
All subjects were allowed to chose any diet they wished during month 5.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Change in Sweet Taste Intensity over Five Months
Tidsramme: Monthly (for five months)
|
Subjects rated the sweetness of pudding and beverage samples that varied in sucrose concentration during each study month to determine how perception changes over time with diet manipulations
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Monthly (for five months)
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Change in Pleasantness Over Five Months
Tidsramme: Monthly (five month participation duration total)
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Subjects rated hedonic value (degree to which the sample was pleasant) for model pudding and beverages that differed in concentration of sucrose once each month over five months to determine how perception changed over time with the diet manipulation
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Monthly (five month participation duration total)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Sucrose detection thresholds
Tidsramme: Every month (for five months)
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Test of the minimum concentration of sucrose solution that subjects can discriminate from water.
Forced-choice, ascending concentration method.
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Every month (for five months)
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Body mass index
Tidsramme: Every month (five months total)
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BMI, calculated based on weight and height.
This was measured both to balance treatment groups and to ensure that assigned diets maintained adequate energy balance (no change in BMI over the study was the ideal outcome for all groups)
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Every month (five months total)
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Diet records
Tidsramme: Every month (five month total)
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Subject reported in detail the types and quantities of the foods and beverages they ate.
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Every month (five month total)
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
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
1. oktober 2010
Primær færdiggørelse (Faktiske)
1. juni 2011
Datoer for studieregistrering
Først indsendt
13. marts 2014
Først indsendt, der opfyldte QC-kriterier
14. marts 2014
Først opslået (Skøn)
18. marts 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
18. marts 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
14. marts 2014
Sidst verificeret
1. marts 2014
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- IND039A01WISE
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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