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Effect of the Quality of Dietary Proteins on the Sleep Young Elite Athletes and the Obese Adolescent (Protmorpheus)

Primary Purpose

Obese Adolescent, Elite Adolescent Athletes

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
tryptophan
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obese Adolescent focused on measuring sleep, adolescent, tryptophan, athletes, obeses

Eligibility Criteria

14 Years - 18 Years (Child, Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de Clermont-FerrandRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

cohorte 1

cohorte 2

cohort 3

Arm Description

Tryptophan (Trp) / Large neutral amino acids (Lnaa) ratio = 0.11

Tryptophan (Trp) / Large neutral amino acids (Lnaa) ratio = 0.07

Tryptophan (Trp) / Large neutral amino acids (Lnaa) ratio = 0.04

Outcomes

Primary Outcome Measures

Change effect of a supplementation with proteins of different Trp/Lnaa ratio on sleep of elite adolescent athletes with mild sleep disturbances
Efficiency of sleep (ratio of time spent in bed / sleep time)

Secondary Outcome Measures

change in biochemical marker related to sleep
measured by blood test : GH, GHRH, TSH, Sérotonine (5HT), Kynurénine, Tryptophane
Change in biochemical markers related food intake
measured by blood test : Insuline, Leptine, Ghreline, Adiponectine, GLP-1, PYY3-36, Nesfatine, Irisine
change in biochemical markers related to inflammation
measured blood test : CRP-us, IL1b, IL6, TNF-alpha, IL4, IL10, sTNFR1 and sTNFR2
Resting metabolic rate kcal per day
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.
muscular fatigue
force measurement : Time in second spent on 60% of MVIC (Maximal Voluntary Isometric Contraction (MVIC) of the knee flexors)
Cognitive performances
Measures by cognitive tests : Stroop test
Cognitive performances
Measures by cognitive tests :Trail marking test
Cognitive performances
Measures by cognitive tests : Barrage test
Cognitive performances
Measures by cognitive tests : PASAT
Cognitive performances
Measures by cognitive tests : Symbol digit test
Energy intake
Energy intake and proportion of the energy derived from each class of macronutrient (carbohydrate, fat, and protein) measured on meals offered "ad-libitum"

Full Information

First Posted
April 5, 2019
Last Updated
November 13, 2019
Sponsor
University Hospital, Clermont-Ferrand
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1. Study Identification

Unique Protocol Identification Number
NCT04041934
Brief Title
Effect of the Quality of Dietary Proteins on the Sleep Young Elite Athletes and the Obese Adolescent
Acronym
Protmorpheus
Official Title
Effect of the Quality of Dietary Proteins on the Sleep Young Elite Athletes and the Obese Adolescent
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 4, 2019 (Actual)
Primary Completion Date
March 1, 2021 (Anticipated)
Study Completion Date
March 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obese Adolescent, Elite Adolescent Athletes
Keywords
sleep, adolescent, tryptophan, athletes, obeses

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Tryptophan (Trp) / Large neutral amino acids (Lnaa) ratio of proteins taken varies-double-blind between sessions
Masking
ParticipantInvestigator
Masking Description
double blind
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
cohorte 1
Arm Type
Experimental
Arm Description
Tryptophan (Trp) / Large neutral amino acids (Lnaa) ratio = 0.11
Arm Title
cohorte 2
Arm Type
Experimental
Arm Description
Tryptophan (Trp) / Large neutral amino acids (Lnaa) ratio = 0.07
Arm Title
cohort 3
Arm Type
Experimental
Arm Description
Tryptophan (Trp) / Large neutral amino acids (Lnaa) ratio = 0.04
Intervention Type
Dietary Supplement
Intervention Name(s)
tryptophan
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change effect of a supplementation with proteins of different Trp/Lnaa ratio on sleep of elite adolescent athletes with mild sleep disturbances
Description
Efficiency of sleep (ratio of time spent in bed / sleep time)
Time Frame
Change from pre-intervention
Secondary Outcome Measure Information:
Title
change in biochemical marker related to sleep
Description
measured by blood test : GH, GHRH, TSH, Sérotonine (5HT), Kynurénine, Tryptophane
Time Frame
day4 day7
Title
Change in biochemical markers related food intake
Description
measured by blood test : Insuline, Leptine, Ghreline, Adiponectine, GLP-1, PYY3-36, Nesfatine, Irisine
Time Frame
day4 day7
Title
change in biochemical markers related to inflammation
Description
measured blood test : CRP-us, IL1b, IL6, TNF-alpha, IL4, IL10, sTNFR1 and sTNFR2
Time Frame
day4 day7
Title
Resting metabolic rate kcal per day
Description
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.
Time Frame
day 7
Title
muscular fatigue
Description
force measurement : Time in second spent on 60% of MVIC (Maximal Voluntary Isometric Contraction (MVIC) of the knee flexors)
Time Frame
day 7
Title
Cognitive performances
Description
Measures by cognitive tests : Stroop test
Time Frame
day 7
Title
Cognitive performances
Description
Measures by cognitive tests :Trail marking test
Time Frame
day 7
Title
Cognitive performances
Description
Measures by cognitive tests : Barrage test
Time Frame
day 7
Title
Cognitive performances
Description
Measures by cognitive tests : PASAT
Time Frame
day 7
Title
Cognitive performances
Description
Measures by cognitive tests : Symbol digit test
Time Frame
day 7
Title
Energy intake
Description
Energy intake and proportion of the energy derived from each class of macronutrient (carbohydrate, fat, and protein) measured on meals offered "ad-libitum"
Time Frame
day 7

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lise Laclautre
Phone
334.73.754.963
Email
promo_interne_drci@chu-clermontferrand.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Livia Fantini
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre
Email
promo_interne_drci@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Livia Fantini

12. IPD Sharing Statement

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Effect of the Quality of Dietary Proteins on the Sleep Young Elite Athletes and the Obese Adolescent

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