NCT04041934

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 1, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

November 4, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

November 14, 2019

Status Verified

November 1, 2019

Enrollment Period

1.3 years

First QC Date

April 5, 2019

Last Update Submit

November 13, 2019

Conditions

Keywords

sleepadolescenttryptophanathletesobeses

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

EXPERIMENTAL

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

Dietary Supplement: tryptophan

cohorte 2

EXPERIMENTAL

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

Dietary Supplement: tryptophan

cohort 3

EXPERIMENTAL

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

Dietary Supplement: tryptophan

Interventions

tryptophanDIETARY_SUPPLEMENT

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.

cohort 3cohorte 1cohorte 2

Eligibility Criteria

Age14 Years - 18 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

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

RECRUITING

MeSH Terms

Interventions

Tryptophan

Intervention Hierarchy (Ancestors)

Amino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Essential

Study Officials

  • Livia Fantini

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

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
Model Details: Tryptophan (Trp) / Large neutral amino acids (Lnaa) ratio of proteins taken varies-double-blind between sessions
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

Locations