- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00768417
Availability of Lipids in Almonds in Healthy Individuals
15. november 2013 opdateret af: Richard Mattes, Purdue University
Mastication of Almonds: Effects of Lipid Bioaccessibility, Appetite, and Hormone Response
Evidence indicates that almond consumption is associated with multiple health benefits.
However, nuts are commonly excluded from diets on the basis that their high energy content may induce weight gain.
Evidence from numerous studies show that this is not the case, yet the mechanism responsible for the less than predicted effect on weight is unknown.
This study aimed to examine the effects of increased mastication on lipid bioavailability and satiety related peptide released in humans.
Its purpose is to provide valuable mechanistic data to support the results from previous completed clinical studies.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This cross-over study consisted of three study periods of four consecutive days separated by at least one week.
During each day of the three study periods, participants were required to consume 55g of almonds split up into 5 g portions.
They were required to chew the almonds 10, 25, or 40 times before swallowing, depending on the treatment.
During each treatment period, all participants followed the same procedures over the four days.
On day one after an overnight fast, participants reported to the laboratory and were presented with 11, 5 gram portions of almonds to chew 10, 25, or 40 times, depending on treatment arm.
The participant remained in the laboratory for 4 hours post-almond consumption for measurements of blood and appetite.
For the remainder of the 4 days, participants consumed all meals in the laboratory and collected all stools passed.
On a separate occasion, recovered particle sizes of masticated almonds were measured by a mechanical sieving process.
Individuals chewed almond samples either 10, 25 or 40 times and expectorated them into sieves.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
20
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Indiana
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West Lafayette, Indiana, Forenede Stater, 47907
- Purdue University, Laboratory forSensory and Ingestive Studies
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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 50 år (Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
University and community sample
Beskrivelse
Inclusion Criteria:
- 18-50 years of age
- BMI 20-25 kg/m2
- Full set of healthy teeth
- Weight stable (<3 kg change in past 3 mo)
Exclusion Criteria:
- Smoker
- Eating Disorders or high level of restraint
- Endocrine disorders
- Pregnant or lactating
- Allergic to nuts
- Taking medication likely to confound study outcomes (meds affecting appetite)
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Case-Crossover
- Tidsperspektiver: Tværsnit
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Participants
Participants completed all 3-arms of this cross-over design study.
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Participants were required to chew 55g grams of almonds per day for four days in 11, 5 gram portions.
Almonds were to be chewed 10 times before swallowing.
Andre navne:
Participants were required to chew 55g grams of almonds per day for four days in 11, 5 gram portions.
Almonds were to be chewed 25 times before swallowing.
Andre navne:
Participants were required to chew 55g grams of almonds per day for four days in 11, 5 gram portions.
Almonds were to be chewed 40 times before swallowing.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Lipid available for absorption as measured by stool collections, appetite measures, blood analysis
Tidsramme: 3, 4 day periods
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3, 4 day periods
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Particle size distribution as measured by mechanical sieving process
Tidsramme: 3 separate sessions
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3 separate sessions
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Richard D Mattes, MPH, PhD, RD, Purdue University
- Studieleder: Bridget A Cassady, B.S., Purdue University
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. april 2006
Primær færdiggørelse (Faktiske)
1. august 2007
Studieafslutning (Faktiske)
1. august 2007
Datoer for studieregistrering
Først indsendt
7. oktober 2008
Først indsendt, der opfyldte QC-kriterier
7. oktober 2008
Først opslået (Skøn)
8. oktober 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
18. november 2013
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
15. november 2013
Sidst verificeret
1. november 2013
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 0511003189
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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