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

NCT ID: NCT04041934

Last Updated: 2019-11-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-04
• Study Completion Date: 2022-03-01

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

Conditions

Obese Adolescent; Elite Adolescent Athletes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

cohorte 1

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

Group Type: EXPERIMENTAL

tryptophan

Intervention Type: DIETARY_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.

cohorte 2

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

Group Type: EXPERIMENTAL

tryptophan

Intervention Type: DIETARY_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 3

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

Group Type: EXPERIMENTAL

tryptophan

Intervention Type: DIETARY_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.

Interventions

tryptophan

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.

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Livia Fantini

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

CHU de Clermont-Ferrand

Clermont-Ferrand, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Lise Laclautre

Role: CONTACT

promo_interne_drci@chu-clermontferrand.fr

334.73.754.963

Facility Contacts

Lise Laclautre

Role: primary

promo_interne_drci@chu-clermontferrand.fr

Other Identifiers

2018-A02680-55

Identifier Type: OTHER

Identifier Source: secondary_id

RBHP 2018 FANTINI

Identifier Type: -

Identifier Source: org_study_id