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Obese AdolescentProtmorpheusNCT04041934

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

A study testing tryptophan in people with Obese Adolescent and Elite Adolescent Athletes, run by University Hospital, Clermont-Ferrand at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 14 to 18 years, men only
Conditions the study is for
Obese Adolescent, Elite Adolescent Athletes
What is being tested?
tryptophan
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteFrance
Study dates
4 Nov 2019to 1 Mar 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 18 years
  • Men only
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • young athletes OR adolescent with BMI > 90 percentiles

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Lise Laclautre contact

334.73.754.963

promo_interne_drci@chu-clermontferrand.fr

France1 site, 1 recruiting

  • CHU de Clermont-Ferrand

    Clermont-Ferrand, 63000

    Lise Laclautre, promo_interne_drci@chu-clermontferrand.fr

    Livia Fantini

    Recruiting

Other trials in France

About this study

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).

Read more

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.

Read the 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.
  1. peripheral quantitative computed tomography (pQCT) of the muscular cross-section (thigh and forearm) at the beginning of the study
Being tested
tryptophan
Keywords
sleep, adolescent, tryptophan, athletes, obeses

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT04041934
Study groupRoleWhat they receive
cohorte 1ExperimentalTryptophan (Trp) / Large neutral amino acids (Lnaa) ratio = 0.11
Receives: Dietary Supplement: tryptophan
cohorte 2ExperimentalTryptophan (Trp) / Large neutral amino acids (Lnaa) ratio = 0.07
Receives: Dietary Supplement: tryptophan
cohort 3ExperimentalTryptophan (Trp) / Large neutral amino acids (Lnaa) ratio = 0.04
Receives: Dietary Supplement: tryptophan

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: Change from pre-intervention

Secondary outcomes (11)

  1. change in biochemical marker related to sleep

    measured by blood test : GH, GHRH, TSH, Sérotonine (5HT), Kynurénine, Tryptophane

    Measured: day4 day7

  2. Change in biochemical markers related food intake

    measured by blood test : Insuline, Leptine, Ghreline, Adiponectine, GLP-1, PYY3-36, Nesfatine, Irisine

    Measured: day4 day7

  3. change in biochemical markers related to inflammation

    measured blood test : CRP-us, IL1b, IL6, TNF-alpha, IL4, IL10, sTNFR1 and sTNFR2

    Measured: day4 day7

  4. 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.

    Measured: day 7

  5. muscular fatigue

    force measurement : Time in second spent on 60% of MVIC (Maximal Voluntary Isometric Contraction (MVIC) of the knee flexors)

    Measured: day 7

  6. Cognitive performances

    Measures by cognitive tests : Stroop test

    Measured: day 7

  7. Cognitive performances

    Measures by cognitive tests :Trail marking test

    Measured: day 7

  8. Cognitive performances

    Measures by cognitive tests : Barrage test

    Measured: day 7

  9. Cognitive performances

    Measures by cognitive tests : PASAT

    Measured: day 7

  10. Cognitive performances

    Measures by cognitive tests : Symbol digit test

    Measured: day 7

  11. 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"

    Measured: day 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2019
  2. Study start4 Nov 2019
  3. Primary completion1 Mar 2021 (estimated)
  4. Study completion1 Mar 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Model description
Tryptophan (Trp) / Large neutral amino acids (Lnaa) ratio of proteins taken varies-double-blind between sessions
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04041934
Sponsor's protocol ID
RBHP 2018 FANTINI
Other IDs
2018-A02680-55
Acronym
Protmorpheus
Status last verified
Nov 2019
First submitted
5 Apr 2019
Last updated
14 Nov 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing tryptophan in people with Obese Adolescent and Elite Adolescent Athletes, run by University Hospital, Clermont-Ferrand at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Lise Laclautre (334.73.754.963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04041934.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2019.

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