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Novel Approach to Assess Metabolic Flexibility in a Respiratory Chamber (METFLEX)

21. august 2021 opdateret af: David McDougal, Pennington Biomedical Research Center
The overarching aim of this study: To determine the effect of different meal compositions (high- vs. low-fat) on metabolic flexibility as it relates to meal-stimulated change in respiratory quotient (ΔRQ1) and sleep (ΔRQ2) metabolic flexibility, as well as the time course changes in respiratory quotient, RQ (i.e., peak RQ, time to peak RQ, nadir RQ, time to nadir, slope).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

10

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Louisiana
      • Baton Rouge, Louisiana, Forenede Stater, 70808-4124
        • Pennington Biomedical Research Center

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 40 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Eligibility criteria include:

    • Healthy male or female
    • Ages 18-40 y
    • BMI between 20 kg/m2 and 30 kg/m2 (±0.5 kg/m2 will be accepted)
    • Are willing to consume pre-prepared meals
    • Are willing to maintain current physical activity, sleep schedule, and dietary habits during the study.
    • Medically cleared for participation in the study by Medical Investigator

Exclusion Criteria:

  • Participants are ineligible to participate (or will be excluded from participating in this study) if they meet any of the following criteria:

    • Unstable weight in the last 3 months [gain or loss >7 lb (or 3.2 kg)]
    • Currently working shift work
    • Smoking or use of tobacco products within the last 3 months
    • Amenorrhea (or absence of regular monthly cycles)
    • History of clinically diagnosed diabetes or a fasting blood glucose >126 mg/dL
    • Average screening blood pressure >140/90 mmHg
    • Previous bariatric surgery (or other surgeries) for obesity or weight loss
    • Use of medications affecting metabolism or sleep
    • History of neurological disease
    • History of cardiovascular disease (or other chronic diseases)
    • Pregnant, planning to become pregnant, or breastfeeding
    • Adherence to special restrained diets (e.g., low-carbohydrate, low-fat, or vegetarian/vegan diets) over 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: Crossover opgave
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: High Fat Meal First
Arm 1 participants randomized to receive high fat meal first, and low fat meal second
Andet: High fat meal
60% fat meal
Andet: Low fat meal
20% fat meal
Eksperimentel: High Fat Meal Second
Arm 2 participants randomized to receive low fat meal first, and high fat meal second
Andet: High fat meal
60% fat meal
Andet: Low fat meal
20% fat meal

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overnight Respiratory Exchange Ratio
Tidsramme: 12 hours

12-h mean of respiratory exchange ratio following each meal type.

measurement interval = 12h following start of meal (7pm)

The respiratory exchange ratio refers to the proportion of macronutrients being oxidized. A respiratory exchange ratio value of 1.0 indicates only carbohydrates are being oxidized, while a ratio value of 0.7 indicates only fats are being oxidized. Intermediate values, such as 0.85, indicates that both carbohydrate and fats are being oxidized.
12 hours

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Sleep Respiratory Exchange Ratio
Tidsramme: 3 h

mean of respiratory exchange ratio following each meal type during sleep period, 2am-5am., 2am-5am.

measurement interval = 3h (2am-5am)

The respiratory exchange ratio refers to the proportion of macronutrients being oxidized. A respiratory exchange ratio value of 1.0 indicates only carbohydrates are being oxidized, while a ratio value of 0.7 indicates only fats are being oxidized. Intermediate values, such as 0.85, indicates that both carbohydrate and fats are being oxidized.
3 h
Peak Increase in Respiratory Exchange Ratio
Tidsramme: 4 h

mean of peak increase in respiratory exchange ratio (Peak values - baseline values) following each meal type

Peak values were defined as the peak respiratory exchange ratio value measured during the post-meal period, 6pm-10pm.

Baseline values were measured 1h prior to meal (5:00-5:45pm)

measurement interval of peak values= 4h (6pm-10pm)

A larger value in this measurement indicates that more carbohydrate than fats were being oxidized as fuel during the measurement period.
4 h
Peak Decrease in Respiratory Exchange Ratio
Tidsramme: 12 h

mean of peak decrease in respiratory exchange ratio (baseline values -nadir values) following each meal type

Peak values were defined as the peak respiratory exchange ratio value measured during the post-meal period, 6pm-10pm.

Baseline values were measured 1h prior to meal (5:00-5:45pm)

measurement interval of nadir values= 12h (6pm-6am)

A larger value in this measurement indicates that more fats than carbohydrate were being oxidized as fuel during the measurement period.
12 h
Time to Peak Respiratory Exchange Ratio
Tidsramme: 12 h

Average time from meal to peak respiratory exchange ratio value

This measurement indicates how long on average it took form the onset of the meal, 6pm, for the participants to achieve their highest/peak respiratory exchange ratio value.
12 h
Time to Nadir Respiratory Exchange Ratio
Tidsramme: 12 h

Average time from meal to nadir respiratory exchange ratio value

This measurement indicates how long on average it took form the onset of the meal, 6pm, for the participants to achieve their lowest/nadir respiratory exchange ratio value.
12 h
Slope of Respiratory Exchange Ratio
Tidsramme: 12 h

This value indicates the speed and magnitude of the participants change in respiratory exchange ratio between the peak and nadir values.

A more negative value in this measurement indicates either a short time interval between the highest and lowest respiratory exchange ratio values measured and/or a large difference between the highest and lowest values of respiratory exchange ratio values measured.
12 h

Samarbejdspartnere og efterforskere

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

Sponsor

Pennington Biomedical Research Center

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)

14. januar 2019

Primær færdiggørelse (Faktiske)

31. december 2019

Studieafslutning (Faktiske)

31. december 2020

Datoer for studieregistrering

Først indsendt

11. februar 2019

Først indsendt, der opfyldte QC-kriterier

11. februar 2019

Først opslået (Faktiske)

15. februar 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. september 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. august 2021

Sidst verificeret

1. august 2021

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • PBRC 2018-029

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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