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Use of Stable Carbon And Nitrogen Isotopes to Improve Dietary Assessment for Cardiovascular Disease (I-CAN)

18. juni 2021 opdateret af: Cheryl A. Anderson, MPH, PhD, University of California, San Diego
In this research study, the investigators will use a novel approach to measure what people eat. The goal is to find out whether stable isotopes that can be measured in blood, hair, and fingernails are better at measuring what people eat than the surveys that are currently used. To meet the goal, the investigators will do three things. First, the investigators will feed study participants known amounts of foods and nutrients. Second, after study participants have eaten the food, the investigators will measure stable isotopes in samples of study participants' blood, hair, and fingernails. Third, the investigators will determine how well these samples reflect what was eaten. The investigators will also give surveys to study participants to determine how well the surveys reflect what was eaten. This will allow the investigators to do a relative comparison of the measurements from isotopes and surveys.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This is a controlled feeding study in which the relative validity of stable carbon and nitrogen isotope ratio analysis as a biomarker of dietary intake is compared to controlled feedings and multiple 24-hour recalls. Participants will be randomly assigned to a sequence of diets to be fed on four occasions. Participants will undergo 24 hours of controlled feeding on four non-consecutive days over a month-long period. On the day after feeding, participants will complete 24-hour dietary recalls, and provide blood, hair, and fingernail samples for isotope ratio analyses. The investigators will use a crossover design and the diets will be either high or low in C4 plants (i.e., corn and cane products). A 24-hour urine collection will be done at home during each 24-hour feeding period. Participants will have height and weight measured at the screening visit. Weight will also be measured at each study visit. Additionally, data will be collected via questionnaires administered at each study visit.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

10

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Forenede Stater
    • California
      • San Diego, California, Forenede Stater, 92093
        • University of California, San Diego

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

21 år til 74 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • men and women;
  • aged 21 and 74 years;
  • no history of chronic disease and in general good health;
  • able to provide primary study outcome; and
  • willing to tolerate study diets designed for controlled feeding.

Exclusion Criteria:

  • recent dietary changes, restrictions, allergies or preferences;
  • health conditions that require management beyond the scope of the study (e.g. heart failure, kidney disease, liver disease, gastrointestinal disorder);
  • history of drug or alcohol abuse;
  • plans to leave the San Diego area before study completion; and
  • lack of suitability per investigators' discretion.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 50g added sugar
Crossover design and each participant receives all 4 experimental arms/doses in random order
Kosttilskud: one 24 hr cycle of meals at a 2000 kcal level
50g added sugar
Eksperimentel: 90g added sugar
Crossover design and each participant receives all 4 experimental arms/doses in random order
Kosttilskud: one 24 hr cycle of meals at a 2000 kcal level + one serving sugar sweetened beverage
90 grams added sugar
Eksperimentel: 130g added sugar
Crossover design and each participant receives all 4 experimental arms/doses in random order
Kosttilskud: one 24 hr cycle of meals at a 2000 kcal level + two servings sugar sweetened beverage
130 grams added sugar
Eksperimentel: 170g added sugar
Crossover design and each participant receives all 4 experimental arms/doses in random order
Kosttilskud: one 24 hr cycle of meals at a 2000 kcal level + three serving sugar sweetened beverage
170 grams added sugar

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Carbon isotope values from blood
Tidsramme: 30 days
The ratio of carbon 13 to carbon 12 in human blood will be determined.
30 days

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Carbon isotope values from hair
Tidsramme: 30 days
The ratio of carbon 13 to carbon 12 in human hair samples will be determined.
30 days
Carbon isotope values from fingernails
Tidsramme: 30 days
The ratio of carbon 13 to carbon 12 in human fingernail samples will be determined.
30 days
Nitrogen isotope values from blood
Tidsramme: 30 days
The ratio of nitrogen-15 to nitrogen 14 in human blood will be determined.
30 days
Nitrogen isotope values from hair
Tidsramme: 30 days
The ratio of nitrogen-15 to nitrogen 14 in human hair will be determined.
30 days
Nitrogen isotope values from fingernails
Tidsramme: 30 days
The ratio of nitrogen-15 to nitrogen 14 in human fingernails will be determined.
30 days

Samarbejdspartnere og efterforskere

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

Sponsor

University of California, San Diego

Efterforskere

  • Ledende efterforsker: Cheryl A. Anderson, PhD, University of California, San Diego

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 (Forventet)

1. august 2021

Primær færdiggørelse (Forventet)

1. februar 2022

Studieafslutning (Forventet)

1. februar 2022

Datoer for studieregistrering

Først indsendt

21. februar 2020

Først indsendt, der opfyldte QC-kriterier

18. juni 2021

Først opslået (Faktiske)

22. juni 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. juni 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. juni 2021

Sidst verificeret

1. juni 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 16IRG27770080

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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