Effect of the Quality of Dietary Proteins on the Sleep Young Elite Athletes and the Obese Adolescent
Protmorpheus
2 other identifiers
interventional
48
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 5, 2019
CompletedFirst Posted
Study publicly available on registry
August 1, 2019
CompletedStudy Start
First participant enrolled
November 4, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2022
CompletedNovember 14, 2019
November 1, 2019
1.3 years
April 5, 2019
November 13, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Change from pre-intervention
Secondary Outcomes (11)
change in biochemical marker related to sleep
day4 day7
Change in biochemical markers related food intake
day4 day7
change in biochemical markers related to inflammation
day4 day7
Resting metabolic rate kcal per day
day 7
muscular fatigue
day 7
- +6 more secondary outcomes
Study Arms (3)
cohorte 1
EXPERIMENTALTryptophan (Trp) / Large neutral amino acids (Lnaa) ratio = 0.11
cohorte 2
EXPERIMENTALTryptophan (Trp) / Large neutral amino acids (Lnaa) ratio = 0.07
cohort 3
EXPERIMENTALTryptophan (Trp) / Large neutral amino acids (Lnaa) ratio = 0.04
Interventions
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.
Eligibility Criteria
You may qualify if:
- young athletes OR adolescent with BMI \> 90 percentiles
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU de Clermont-Ferrand
Clermont-Ferrand, 63000, France
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Livia Fantini
University Hospital, Clermont-Ferrand
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- double blind
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 5, 2019
First Posted
August 1, 2019
Study Start
November 4, 2019
Primary Completion
March 1, 2021
Study Completion
March 1, 2022
Last Updated
November 14, 2019
Record last verified: 2019-11