Novel Approach to Assess Metabolic Flexibility in a Respiratory Chamber (METFLEX)
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
Louisiana
-
Baton Rouge, Louisiana, Verenigde Staten, 70808-4124
- Pennington Biomedical Research Center
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Fundamentele wetenschap
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: High Fat Meal First
Arm 1 participants randomized to receive high fat meal first, and low fat meal second
|
60% fat meal
20% fat meal
|
|
Experimenteel: High Fat Meal Second
Arm 2 participants randomized to receive low fat meal first, and high fat meal second
|
60% fat meal
20% fat meal
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Overnight Respiratory Exchange Ratio
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Sleep Respiratory Exchange Ratio
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- PBRC 2018-029
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .