Novel Approach to Assess Metabolic Flexibility in a Respiratory Chamber (METFLEX)
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Louisiana
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Baton Rouge, Louisiana, Forente stater, 70808-4124
- Pennington Biomedical Research Center
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: High Fat Meal First
Arm 1 participants randomized to receive high fat meal first, and low fat meal second
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60% fat meal
20% fat meal
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Eksperimentell: High Fat Meal Second
Arm 2 participants randomized to receive low fat meal first, and high fat meal second
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60% fat meal
20% fat meal
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Overnight Respiratory Exchange Ratio
Tidsramme: 12 hours
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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 |
Tiltaksbeskrivelse |
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
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Peak Increase in Respiratory Exchange Ratio
Tidsramme: 4 h
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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
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Time to Peak Respiratory Exchange Ratio
Tidsramme: 12 h
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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
|
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Time to Nadir Respiratory Exchange Ratio
Tidsramme: 12 h
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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
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Slope of Respiratory Exchange Ratio
Tidsramme: 12 h
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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
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Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- PBRC 2018-029
Legemiddel- og utstyrsinformasjon, studiedokumenter
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