Evidence map›Paper›PMID 25943490›Full record

Trial reportNutrition journal2015

Placebo-controlled dietary intervention of stress-induced neurovegetative disorders with a specific amino acid composition: a pilot-study.

Katrin Chaborski, Norman Bitterlich, Birgit Alteheld, Elke Parsi, Christine Metzner

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Nutrition journal, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01425983 (Dietary Intervention of Stress-Induced Neurovegetative Disorders in Men and Women With a Specific Amino Acid Composition With Micronutrients), which is not on this map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
0.4field-weighted citation impact, top 47% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01425983 phase3completednot on this map

Dietary Intervention of Stress-Induced Neurovegetative Disorders in Men and Women With a Specific Amino Acid Composition With Micronutrients

TypeinterventionalSponsorKyberg Vital GmbHRan2011 to 2012Enrolled80ConditionsNervous System Disorder, Imbalance of Constituents of Food IntakeArmsamino acid composition (asn01), Placebo
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it, 4 citations in OpenAlex.

  1. Use of Salivary Diurnal Cortisol as an Outcome Measure in Randomised Controlled Trials: a Systematic Review.Annals of behavioral medicine : a publication of the Society of Behavioral Medicine · 2016
    Pooled it
  2. Trial
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 2 institutions in 1 country.

Katrin ChaborskiDepartment of Nutrition and Food Sciences, Nutritional Physiology, University of Bonn, Endenicher Allee 11-13, D-53115, Bonn, Germany. kachab@uni-bonn.de.
Norman BitterlichDepartment of Biostatistics, Medicine and Service Ltd, Boettcherstr. 10, D-09117, Chemnitz, Germany. bitterlich@medizinservice-sachsen.de.
Birgit AlteheldDepartment of Nutrition and Food Sciences, Nutritional Physiology, University of Bonn, Endenicher Allee 11-13, D-53115, Bonn, Germany. b.alteheld@uni-bonn.de.
Elke ParsiOutpatient Practice of Cardiology/Angiology, Suermondtstr. 13, D-13053, Berlin, Germany. elke.parsi@t-online.de.
Christine MetznerDepartment of Internal Medicine III, University Hospital, RWTH, Pauwelsstraße 44, D-52074, Aachen, Germany. christine.metzner@rwth-aachen.de.
University of Bonn · DERWTH Aachen University · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPsychosocial stress leads to altered neuroendocrine functions, such as serotonergic dysfunction, as well as alterations of the autonomic nervous system and the hypothalamic-pituitary-adrenal (HPA)-axis activity resulting in an imbalance between inhibitory and excitatory neurotransmitters. Poor dietary intake of L-tryptophan as a precursor of serotonin increases sensitivity to stress.

methodsThis randomized, double-blind, placebo-controlled study investigated the effect of a specific amino acid composition with micronutrients on neurovegetative disorders and the cardiometabolic risk profile in psychosocially stressed patients. 32 patients (18-65 years) were eligible for protocol analysis. Points in the Psychological Neurological Questionnaire (PNF), clinical and blood parameter, in particular the serotonin level, salivary cortisol levels, and dietary intake were evaluated at baseline and 12 weeks after supplementation.

resultsThe intervention in the form of either verum or placebo resulted in both groups in a significant decrease of neurovegetative symptoms. However, patients of the placebo group achieved significantly less points in the PNF compared to the verum group. But the rate of responders (≥10 points loss in PNF) was not significantly different between the groups. The macronutrient intake did not differ between verum and placebo group. On average, the HPA-axis was not disturbed in both groups. Blood serotonin indicated in both groups no significant correlation with dietary tryptophan intake or PNF.

conclusionsDaily supplementation of a specific amino acid composition with micronutrients in psychologically stressed patients resulted in no improvement of neurovegetative disorders as measured by the PNF when compared to the placebo group.

trial registrationClinical Trials.gov ( NCT01425983 ).

Indexed as

AdolescentAdultAgedAmino AcidsAutonomic Nervous System DiseasesDietary SupplementsDiet TherapyDouble-Blind MethodFemaleHumansHydrocortisoneHypothalamo-Hypophyseal SystemMaleMicronutrientsMiddle AgedPilot ProjectsAmino AcidsHydrocortisoneMicronutrientsSerotoninTryptophan

Identifiers

PMID25943490
PMCPMC4431034
OpenAlexW1783001227

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.