Properties of Dietary Fibre and Energy Intake (ProVe)
23. december 2011 opdateret af: Wageningen University
Properties of Dietary Fibre and Energy Intake: an Intervention to Study the Effect of Physicochemical Properties of Dietary Fibre on Energy Intake and Underlying Mechanisms
Dietary fibers likely have a role in body weight management.
They may increase satiety and, as a consequence, reduce energy intake during the next meal.
There are, however, many different types of dietary fiber, which have diverse physical properties and can therefore impact these outcomes differently.
It is, however, unclear whether dietary fibers with different properties lead to differences in energy intake during the next meal.
The objective of this study is to study the effect of pectin in 4 different physicochemical states on ad libitum energy intake and possible underlying mechanisms; i.e. gastrointestinal hormones, gastric emptying rate, feelings of satiety and the method of fiber supplementation.
We hypothesize that viscous and gelling fibers will reduce ad libitum energy intake compared to low viscous and low gelling fibers.
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
29
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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Wageningen, Holland, 6702
- Wageningen University
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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 30 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Han
Beskrivelse
Inclusion Criteria:
- Age 18-30 year
- BMI 18.5-25 kg/m2
- Healthy as judged by the participant
Exclusion Criteria:
- Females
- Weight loss or weight gain of more than 5 kg during the last 2 months
- Using an energy restricted diet during the last 2 months
- Lack of appetite for any reason
- Restrained eater: >2.89, measured by DEBQ (35).
- Smoking
- Heavy alcohol use: >5 drinks/day (36).
- Reported stomach or bowel disease
- Reported diabetes
- Reported thyroid disease or any other endocrine disorder
- Reported intolerance for pectin, bread, gluten, dairy or not liking of the research foods
- Anemia: Hb<8.0 mmol/l
- Fasting glucose levels >5.8 mmol/l
- Blood donation from 6 weeks prior to the study until the end of the study
- Experienced any problems with drawing blood in the past
- Antecubital veins not considered suitable for blood drawing by means of a catheter
- Thesis students or employees of the division of Human Nutrition
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: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Placebo komparator: control
No additions of fiber to a breakfast meal
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liquid breakfast without addition of fiber
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Aktiv komparator: low viscous, low gelling
low viscous, low gelling fibre added to breakfast meal
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10g of low viscous, low gelling pectin dissolved in a liquid breakfast
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Aktiv komparator: high viscous, low gelling
high viscous, low gelling fibre added to breakfast meal
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10g of high viscous, low gelling pectin dissolved in a liquid breakfast
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Aktiv komparator: low viscous, high gelling
low viscous, high gelling fibre added to breakfast meal
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10g of low viscous, high gelling pectin dissolved in a liquid breakfast
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Aktiv komparator: high viscous, high gelling
high viscous, high gelling fibre added to breakfast meal
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10g of high viscous, high gelling pectin dissolved in a liquid breakfast
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Aktiv komparator: fibre supplement
high viscous, high gelling fibre is added, not to the breakfast meal, but as supplement
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10g of high viscous, high gelling pectin provided as a dietary supplement, a liquid breakfast is served seperately
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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energy intake
Tidsramme: 3 hours
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3 hours after ingesting the test breakfast ad libitum energy intake is measured.
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3 hours
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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appetite sensations
Tidsramme: 3 hours
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appetite is measured by VAS scales over a period of 3 hours after ingestion of a test breakfast
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3 hours
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satiety hormones
Tidsramme: 3 hours
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satiety hormones (ghrelin, PYY, GLP-1, CCK) are measured over a period of 3 hours after ingestion of a test breakfast
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3 hours
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gastric emptying rate
Tidsramme: 3 hours
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gastric emptying rate is measured over a period of 3 hours after ingestion of a test breakfast
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3 hours
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method of supplementation
Tidsramme: 3 hours
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One of the fibers will be offered as tablets that will be ingested with a glass of water right after the test meal.
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3 hours
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Edith Feskens, PHd, Wageningen University
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. december 2010
Primær færdiggørelse (Faktiske)
1. maj 2011
Studieafslutning (Faktiske)
1. maj 2011
Datoer for studieregistrering
Først indsendt
8. december 2010
Først indsendt, der opfyldte QC-kriterier
8. december 2010
Først opslået (Skøn)
9. december 2010
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
26. december 2011
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
23. december 2011
Sidst verificeret
1. december 2011
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- METC-10/22
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 .