Clinical trial NCT04041934: Effect of the Quality of Dietary Proteins on the Sleep Young Elite Athletes and the Obese Adolescent
Official title: Effect of the Quality of Dietary Proteins on the Sleep Young Elite Athletes and the Obese Adolescent
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obese Adolescent
Elite Adolescent Athletes
Keywords: sleep
adolescent
tryptophan
athletes
obeses
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2019-08-01
Enrollment: 48
Sex: MALE
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Tryptophan (Trp) / Large neutral amino acids (Lnaa) ratio of proteins taken varies-double-blind between sessions
Primary purpose: PREVENTION

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.

  1. peripheral quantitative computed tomography (pQCT) of the muscular cross-section (thigh and forearm) at the beginning of the study

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

Primary outcomes:
measure: Change effect of a supplementation with proteins of different Trp/Lnaa ratio on sleep of elite adolescent athletes with mild sleep disturbances
timeFrame: Change from pre-intervention
Secondary outcomes:
measure: change in biochemical marker related to sleep
timeFrame: day4 day7
measure: Change in biochemical markers related food intake
timeFrame: day4 day7
measure: change in biochemical markers related to inflammation
timeFrame: day4 day7
measure: Resting metabolic rate kcal per day
timeFrame: day 7
measure: muscular fatigue
timeFrame: day 7
measure: Cognitive performances
timeFrame: day 7
measure: Cognitive performances
timeFrame: day 7
measure: Cognitive performances
timeFrame: day 7
measure: Cognitive performances
timeFrame: day 7
measure: Cognitive performances
timeFrame: day 7
measure: Energy intake
timeFrame: day 7
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Livia Fantini
role: PRINCIPAL_INVESTIGATOR
References: