- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04041934
Effect of the Quality of Dietary Proteins on the Sleep Young Elite Athletes and the Obese Adolescent (Protmorpheus)
Adolescence is characterized by major transitions in sleep and circadian rhythm. This rapid pivotal period increases the risks of sleep debt and poor sleep quality, leading to pronounced diurnal fatigue and drowsiness . Some adolescent's populations are more vulnerable than others to poor sleep. Obesity and elite sports involvement are two factors that have been distinctly associated with disturbed sleep. Several studies show that obesity was associated with a decrease in sleep efficiency and increased arousals . On the other hand, recent studies point out that sleep problem is widespread in young athletes which substantially increase the risks of injury, burnout and concussions .
Despite the importance of sleep in holistic development, physical (i.e. recovery, metabolism, muscle growth, weight control), cognitive (i.e. learning, memory, decision-making, Vigilance) and athletic performances (Fullagar et al., 2015).
A wide range of recent papers emphasize that some nutrients take part in the regulation of internal clock and sleep quality. The effect of tryptophan (Trp) on sleep was lifted on the basis of the serotonergic hypothesis. Serotonin (5-HT) is synthesized from Trp circulating in the brain following two-step procedure in raphe neurons. Serotonin, in turn, is a precursor of melatonin and both molecules contribute to the regulation of sleep-wake behaviors. However, Trp is an essential amino acid, which means that it cannot be synthesized by the organism, and must exclusively be provided via degradation of proteins from the diet. The passage of tryptophan to the brain is assured through carrier disposed at the blood-brain barrier level. However, carrier transport depends on other competitive amino acids (LNAAs: leucine, isoleucine, valine, phenylalanine, and tyrosine). Therefore, increased brain uptake of tryptophan does not depend only on Trp concentrations but rather on the blood Trp / LNAA ratio.
PROTMORPHEUS trial, was designed to examine how supplementation with proteins of different Trp/LNAA ratio affect sleep on adolescents (obese, athletes) with mild sleep disturbances.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Double-blind controlled pre-post trial where each subject acts as his own control.
Three measurement sessions will be performed for each teenager. Each session will be conducted over a week. Each teenager will participate in three protein enrichment sessions: PROT1 session, PROT2 session, and Tryptophan ratio (Trp) / neutral amino acids (AAN) reference session (PROT REF) (PROT1: ratio = 0.07, PROT2 session: ratio = 0.11 and PROT REF session: ratio = 0.04). During these sessions the protein intake will be doubled with regard to recommended dietary intakes through the consumption of protein shakes (from 0.8 g per kg of body weight to 1.6 g per kg).
At each session:
- 2 EEG sleep assessments
- 2 evaluations of the biological profile from fasting blood samples
- 2 evaluations of melatonin peak from salivary specimens
- 1 assessment of physical activity and sedentary lifestyle
- 1 evaluation of the metabolic response to submaximal exercise
- 1 assessment of muscle strength and fatigue
1 assessment of cognitive performance Control of food intake (3 days at RDI + 3 days with doubled protein intake) will be achieved by preparing meals and weighing food. An evaluation of the ad libitum food intake of the 7th day will be carried out by the weighing method.
- peripheral quantitative computed tomography (pQCT) of the muscular cross-section (thigh and forearm) at the beginning of the study
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Clermont-Ferrand, France, 63000
- Recruiting
- CHU de Clermont-Ferrand
-
Principal Investigator:
- Livia Fantini
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- young athletes OR adolescent with BMI > 90 percentiles
Exclusion Criteria:
- Disorders and / or pathology of sleep and chronic diseases of the digestive tract
- Medical or surgical history not compatible with the study, any other chronic illness or injury that may interfere with the subject's abilities
- Take medication that may interfere with the results of the study (corticosteroids ...) or sleeping pills
- Surgical intervention in the previous 3 months
- Regular consumption of tobacco, cannabis or alcohol
- Special diet
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: cohorte 1
Tryptophan (Trp) / Large neutral amino acids (Lnaa) ratio = 0.11
|
Each experimental session will be carried out over a week.
Adolescents will take part randomly in three sessions.
In order to limit inter-individual differences, the diet of the first 3 days will be fixed to the RDA followed by 3 days where dietary intake will be supplemented with different protein (PROT REF : ratio = 0,04 PROT1 : ratio = 0,07, session PROT2 : ratio = 0,11).
Tryptophan (Trp) / Large neutral amino acids (Lnaa) ratio of proteins taken varies-double-blind between sessions.
All proteins had the same dose and packages.
Neither the researcher nor the participants were aware of the quality of the protein.
|
Experimental: cohorte 2
Tryptophan (Trp) / Large neutral amino acids (Lnaa) ratio = 0.07
|
Each experimental session will be carried out over a week.
Adolescents will take part randomly in three sessions.
In order to limit inter-individual differences, the diet of the first 3 days will be fixed to the RDA followed by 3 days where dietary intake will be supplemented with different protein (PROT REF : ratio = 0,04 PROT1 : ratio = 0,07, session PROT2 : ratio = 0,11).
Tryptophan (Trp) / Large neutral amino acids (Lnaa) ratio of proteins taken varies-double-blind between sessions.
All proteins had the same dose and packages.
Neither the researcher nor the participants were aware of the quality of the protein.
|
Experimental: cohort 3
Tryptophan (Trp) / Large neutral amino acids (Lnaa) ratio = 0.04
|
Each experimental session will be carried out over a week.
Adolescents will take part randomly in three sessions.
In order to limit inter-individual differences, the diet of the first 3 days will be fixed to the RDA followed by 3 days where dietary intake will be supplemented with different protein (PROT REF : ratio = 0,04 PROT1 : ratio = 0,07, session PROT2 : ratio = 0,11).
Tryptophan (Trp) / Large neutral amino acids (Lnaa) ratio of proteins taken varies-double-blind between sessions.
All proteins had the same dose and packages.
Neither the researcher nor the participants were aware of the quality of the protein.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change effect of a supplementation with proteins of different Trp/Lnaa ratio on sleep of elite adolescent athletes with mild sleep disturbances
Time Frame: Change from pre-intervention
|
Efficiency of sleep (ratio of time spent in bed / sleep time)
|
Change from pre-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in biochemical marker related to sleep
Time Frame: day4 day7
|
measured by blood test : GH, GHRH, TSH, Sérotonine (5HT), Kynurénine, Tryptophane
|
day4 day7
|
Change in biochemical markers related food intake
Time Frame: day4 day7
|
measured by blood test : Insuline, Leptine, Ghreline, Adiponectine, GLP-1, PYY3-36, Nesfatine, Irisine
|
day4 day7
|
change in biochemical markers related to inflammation
Time Frame: day4 day7
|
measured blood test : CRP-us, IL1b, IL6, TNF-alpha, IL4, IL10, sTNFR1 and sTNFR2
|
day4 day7
|
Resting metabolic rate kcal per day
Time Frame: day 7
|
Resting metabolic rate.
Resting metabolic rate (RMR) will be measured under fasted state, using indirect calorimetry (MetaMax 3b, Cortex Biophysik, Leipzig, Germany).
In agreement with the manufacturer's recommendations gas analysis will be calibrated before the test.
The test will be held in a thermoneutral environment (22-25 °C).
Participants will extend in a supine position for 45 min before starting the measurements.
After achieving a steady state, O2 consumption and CO2 production standardized for temperature, barometric pressure and humidity will be recorded at 1 min intervals for 20-45 min and will be averaged over the whole measurement period.
After that, RMR (in kcal/day) and respiratory quotient (ratio of CO2/O2) will be calculated.
|
day 7
|
muscular fatigue
Time Frame: day 7
|
force measurement : Time in second spent on 60% of MVIC (Maximal Voluntary Isometric Contraction (MVIC) of the knee flexors)
|
day 7
|
Cognitive performances
Time Frame: day 7
|
Measures by cognitive tests : Stroop test
|
day 7
|
Cognitive performances
Time Frame: day 7
|
Measures by cognitive tests :Trail marking test
|
day 7
|
Cognitive performances
Time Frame: day 7
|
Measures by cognitive tests : Barrage test
|
day 7
|
Cognitive performances
Time Frame: day 7
|
Measures by cognitive tests : PASAT
|
day 7
|
Cognitive performances
Time Frame: day 7
|
Measures by cognitive tests : Symbol digit test
|
day 7
|
Energy intake
Time Frame: day 7
|
Energy intake and proportion of the energy derived from each class of macronutrient (carbohydrate, fat, and protein) measured on meals offered "ad-libitum"
|
day 7
|
Collaborators and Investigators
Investigators
- Principal Investigator: Livia Fantini, University Hospital, Clermont-Ferrand
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RBHP 2018 FANTINI
- 2018-A02680-55 (Other Identifier: 2018-A02680-55)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obese Adolescent
-
Istanbul University - Cerrahpasa (IUC)RecruitingAdolescent Obesity | Obese | Child Obesity | Exercise CapacityTurkey
-
University of CoimbraRecruitingAdolescent Behavior | Adolescent - Emotional ProblemPortugal
-
National Institute of Environmental Health Sciences...RecruitingAdolescent Health | Pediatrics | Adolescent Development | Reproductive Physiological ProcessesUnited States
-
Zagazig UniversityCompletedAbdominal Surgery | Obese PatientsEgypt
-
University Hospital, GhentCompleted
-
Bristol-Myers SquibbCompletedObese But Otherwise Healthy ParticipantsUnited States
-
Beth Israel Deaconess Medical CenterCompletedObese | Lean | Obese DiabeticsUnited States
-
Hospital Clinic of BarcelonaTerminatedObese Pregnant WomenSpain
-
Sabrin Mohamed Taha AbdelwahabCompletedObese Women With PCOSEgypt
Clinical Trials on tryptophan
-
Indiana University School of MedicineCompleted
-
The Hospital for Sick ChildrenCompleted
-
Massachusetts General HospitalCompletedFasting Glucose | Metformin Response | Tryptophan Concentration | Metformin Concentration | Diet TolerabilityUnited States
-
University of GroningenCompleted
-
McMaster UniversityCanadian Institutes of Health Research (CIHR); National Research Agency, FranceCompletedDiet ModificationCanada
-
Maastricht University Medical CenterTop Institute Food and NutritionCompleted
-
Rambam Health Care CampusBeersheva Mental Health CenterCompleted
-
Fundació Sant Joan de DéuInstituto de Salud Carlos IIICompleted
-
Qilu Hospital of Shandong UniversityRecruiting