- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04097171
The Effect of Diet Composition on Performance, Expenditure, Blood Lipids, and Appetite Hormones in Highly Trained Cyclists (DCAP)
The Effect of Diet Composition on Performance, Energy Expenditure, Blood Lipids and Lipoproteins, and Cognitive Function and Mood States in Highly Trained Cyclists
Studieoversigt
Detaljeret beskrivelse
Traditionally, a high carbohydrate diet is recommended for elite endurance athletes and sub-elite, highly trained recreational athletes competing in endurance events. However, recently the ketogenic diet (extremely low carbohydrate content) has become popular in these populations. The effect on endurance exercise performance, energy expenditure, postprandial blood profiles, and cognitive function and mood states requires further investigation.
In this study, highly trained recreational cyclists and triathletes will adhere to each diet (high-carbohydrate and ketogenic) for 14 days in a crossover design. Experimental trials at baseline and after each diet will evaluate endurance cycling performance (time trial), resting energy expenditure, the thermic effect of food of test meals corresponding in composition to each diet, postprandial responses of blood lipids, glucose and appetite hormones, and cognitive function and mood states.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Texas
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Fort Worth, Texas, Forenede Stater, 76129
- Texas Christian University
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- >100-150km of cycling per week
- VO2max > 80th percentile for sex and age (adjusted for cycle ergometry)
- apparently healthy
Exclusion Criteria:
- weight loss supplements/medications/diet
- extreme dietary patterns (e.g. extremely high or low carbohydrate)
- nicotine use
- heavy alcohol use (>7 drinks/week female; >14 drinks/week male)
- food allergies
- diabetes
- heart disease
- stroke
- liver/kidney/thyroid disease
- anemia
- eating disorders
- uncontrolled hypertension
- pulmonary/orthopedic/musculoskeletal problems that prevent exercise
- surgery that affects swallowing and digestion
- claustrophobia
Studieplan
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 |
|---|---|
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Eksperimentel: High Carbohydrate Diet
Participants will consume a high carbohydrate diet (65-75% of total energy intake).
Protein intake will be standardized at 15% of total energy intake.
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Participants will consume each diet for 14 days in a crossover design.
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Eksperimentel: Ketogenic Diet
Participants will consume a low carbohydrate diet (<5-10% of total energy intake).
Protein intake will be standardized at 15% of total energy intake.
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Participants will consume each diet for 14 days in a crossover design.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Endurance Cycling Performance
Tidsramme: 180 min after the meal begins
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Time to completion in a 30-kilometer simulated time trial
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180 min after the meal begins
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Respiratory Exchange Ratio
Tidsramme: Change from baseline at 30 min, 60 min, 90 min, 120 min, 150 min, 180 min, 192 min, 204 min, 216 min, 228 min and 240 min after the meal begins
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Indirect calorimetry fasted, postprandial, and during exercise
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Change from baseline at 30 min, 60 min, 90 min, 120 min, 150 min, 180 min, 192 min, 204 min, 216 min, 228 min and 240 min after the meal begins
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Muscle Fuel Rating
Tidsramme: Change from baseline at 180 min and 240 min after the meal begins
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Ultrasound echogenicity of Rectus Femoris
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Change from baseline at 180 min and 240 min after the meal begins
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Oxygen consumption (VO2)
Tidsramme: At 192 min, 204 min, 216 min, 228 min and 240 min after the meal begins
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Indirect calorimetry during exercise
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At 192 min, 204 min, 216 min, 228 min and 240 min after the meal begins
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Rating of Perceived Exertion (RPE)
Tidsramme: At 192 min, 204 min, 216 min, 228 min and 240 min after the meal begins
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6-20 Borg's scale during exercise
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At 192 min, 204 min, 216 min, 228 min and 240 min after the meal begins
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Thermic Effect of Food (postprandial energy expenditure)
Tidsramme: Change from baseline at 30 min, 60 min, 90 min, 120 min, 150 min, 180 min after the meal begins
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Fasted vs. postprandial indirect calorimetry
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Change from baseline at 30 min, 60 min, 90 min, 120 min, 150 min, 180 min after the meal begins
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Subjective appetite ratings
Tidsramme: Change from baseline at 60 min, 120 min, 180 min after the meal begins
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Visual Analog Scale (Scale 1: Perception of Hunger [0-100 mm]; Scale 2: Perception of Fullness [0-100 mm]; Scale 3: Desire to Eat [0-100 mm]
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Change from baseline at 60 min, 120 min, 180 min after the meal begins
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Appetite hormones including ghrelin, leptin, insulin, and Peptide-YY
Tidsramme: Change from baseline at 30 min, 60 min, 120 min, 180 min and 240 min
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Fasted, postprandial & post exercise blood concentration of appetite hormones
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Change from baseline at 30 min, 60 min, 120 min, 180 min and 240 min
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Blood glucose
Tidsramme: Change from baseline at 180 min and 240 min after the meal begins; on day 7 of each diet
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Fasted, postprandial & post exercise blood concentration of glucose
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Change from baseline at 180 min and 240 min after the meal begins; on day 7 of each diet
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Blood pressure
Tidsramme: Change from baseline at 180 min after the meal begins
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Fasted, postprandial & post exercise
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Change from baseline at 180 min after the meal begins
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Cognitive function
Tidsramme: At 180 min and 240 min after the meal begins
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Stroop test
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At 180 min and 240 min after the meal begins
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Mood state questionnaire
Tidsramme: At 180 min and 240 min after the meal begins
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Abbreviated Profile of Mood States; 40-item scale; Likert scale from 0 = "not at all" to 4 = "extremely"
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At 180 min and 240 min after the meal begins
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Resting Metabolic Rate
Tidsramme: At baseline before meal begins
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Indirect calorimetry in fasted state
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At baseline before meal begins
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Blood lipids including (triglycerides, total cholesterol, low density lipoprotein, and high-density lipoprotein)
Tidsramme: Change from baseline at 30 min, 60 min, 120 min, 180 min, 192 min, 204 min, 216 min, 228 min and 240 min after the meal begins
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Fasted and postprandial in mg/dL
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Change from baseline at 30 min, 60 min, 120 min, 180 min, 192 min, 204 min, 216 min, 228 min and 240 min after the meal begins
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- CT2019MS3
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
IPD-delingsadgangskriterier
IPD-deling Understøttende informationstype
- Studieprotokol
- Statistisk analyseplan (SAP)
- Analytisk kode
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