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Fatty Acid Biomarkers of Carbohydrate Intake (CARBIO)

14. november 2018 opdateret af: Uppsala University

Circulating Fatty Acids as Biomarkers of Dietary Carbohydrates: a Randomized Trial

The overall aim is to investigate if circulating fatty acids and lipids are influenced by alterations in carbohydrate amount and quality.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

In this isocaloric clinical cross-over trial, the investigators aim to investigate if circulating fatty acids and lipids are influenced by alterations in carbohydrate amount and quality. The investigators intend to evaluate if changes in carbohydrate quantity and quality (including sugar) influence circulating even-chain saturated fatty acids or if fatty acid-derived indices of desaturation and de novo lipogenesis are more sensitive biomarkers of carbohydrate intake. By performing untargeted lipidomic analyses, the investigators aim to search for novel lipid biomarkers of carbohydrate quantity and quality. The investigators also want to evaluate the influence of moderate alterations of carbohydrate and sugar intake on lipoproteins, insulin sensitivity, inflammatory proteins.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

19

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Sverige
      • Uppsala, Sverige, 75185
        • Uppsala Univeristy Hospital

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

20 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • BMI 20-38

Exclusion Criteria:

  • abnormal lab tests (assessed by screening and judged by a physician), diabetes, cardiovascular, kidney, liver or malignant disease, and weight-loss (±3kg) the preceding 3 months of screening. Extreme diets, i.e. very-low carbohydrate diets, intermittent fasting, vegan diets or allergic to gluten

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: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Fat - Sugar - Fiber
Intervention: consuming diets rich in fat, rich in sugar, and rich in fibers during treatment periods 1, 2, and 3, respectively. Treatment periods are separated by one week of habitual diet.
Andet: Low carbohydrate diet
Diet low in carbohydrates (38%E), but higher in total and saturated fat.
Andet: High carbohydrate, high sugar diet
Diet high in carbohydrates (53%E) and sugars, but low in wholegrain, rye and wheat fibre.
Andet: High carbohydrate, low sugar diet
Diet high in carbohydrates (53%E), wholegrain, rye and wheat fibre, but low in sugars.
Aktiv komparator: Fat - Fiber - Sugar
Intervention: consuming diets rich in fat, rich in fiber, and rich sugar during treatment periods 1, 2, and 3, respectively. Treatment periods are separated by one week of habitual diet.
Andet: Low carbohydrate diet
Diet low in carbohydrates (38%E), but higher in total and saturated fat.
Andet: High carbohydrate, high sugar diet
Diet high in carbohydrates (53%E) and sugars, but low in wholegrain, rye and wheat fibre.
Andet: High carbohydrate, low sugar diet
Diet high in carbohydrates (53%E), wholegrain, rye and wheat fibre, but low in sugars.
Aktiv komparator: Sugar - Fiber - Fat
Intervention: Consuming diets rich in sugar, rich in fiber, and rich in fat during treatment periods 1, 2, and 3, respectively. Treatment periods are separated by one week of habitual diet.
Andet: Low carbohydrate diet
Diet low in carbohydrates (38%E), but higher in total and saturated fat.
Andet: High carbohydrate, high sugar diet
Diet high in carbohydrates (53%E) and sugars, but low in wholegrain, rye and wheat fibre.
Andet: High carbohydrate, low sugar diet
Diet high in carbohydrates (53%E), wholegrain, rye and wheat fibre, but low in sugars.
Aktiv komparator: Sugar - Fat - Fiber
Intervention: Consuming diets rich in sugar, rich in fat, and rich in fiber during treatment periods 1, 2, and 3, respectively. Treatment periods are separated by one week of habitual diet.
Andet: Low carbohydrate diet
Diet low in carbohydrates (38%E), but higher in total and saturated fat.
Andet: High carbohydrate, high sugar diet
Diet high in carbohydrates (53%E) and sugars, but low in wholegrain, rye and wheat fibre.
Andet: High carbohydrate, low sugar diet
Diet high in carbohydrates (53%E), wholegrain, rye and wheat fibre, but low in sugars.
Aktiv komparator: Fiber - Sugar - Fat
Intervention: Consuming diets rich in fiber, rich in sugar, and rich in fat during treatment periods 1, 2, and 3, respectively. Treatment periods are separated by one week of habitual diet.
Andet: Low carbohydrate diet
Diet low in carbohydrates (38%E), but higher in total and saturated fat.
Andet: High carbohydrate, high sugar diet
Diet high in carbohydrates (53%E) and sugars, but low in wholegrain, rye and wheat fibre.
Andet: High carbohydrate, low sugar diet
Diet high in carbohydrates (53%E), wholegrain, rye and wheat fibre, but low in sugars.
Aktiv komparator: Fiber - Fat - Sugar
Intervention: consuming diets rich in fiber, rich in fat, and rich in fiber during treatment periods 1, 2, and 3, respectively. Treatment periods are separated by one week of habitual diet.
Andet: Low carbohydrate diet
Diet low in carbohydrates (38%E), but higher in total and saturated fat.
Andet: High carbohydrate, high sugar diet
Diet high in carbohydrates (53%E) and sugars, but low in wholegrain, rye and wheat fibre.
Andet: High carbohydrate, low sugar diet
Diet high in carbohydrates (53%E), wholegrain, rye and wheat fibre, but low in sugars.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Palmitic acid in different plasma fractions
Tidsramme: 14-20 days
Measured by liquid gas chromatography (GC)
14-20 days

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Even-chain saturated fatty acids (i.e. 14:0, 18:0) and monounsaturated fatty acids
Tidsramme: 14-20 days
Measured by liquid GC
14-20 days

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Desaturation indices end lipogenic indices
Tidsramme: 14-20 days
These indices are product-to-precursor fatty acids measured by GC
14-20 days

Samarbejdspartnere og efterforskere

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

Sponsor

Uppsala University

Efterforskere

  • Ledende efterforsker: Ulf Riserus, PhD, Uppsala 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 (Faktiske)

25. oktober 2017

Primær færdiggørelse (Faktiske)

1. juni 2018

Studieafslutning (Faktiske)

1. juni 2018

Datoer for studieregistrering

Først indsendt

22. september 2017

Først indsendt, der opfyldte QC-kriterier

22. september 2017

Først opslået (Faktiske)

27. september 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. november 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. november 2018

Sidst verificeret

1. november 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CARBIO

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Betingelser

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