None listed
Conditions
Brief summary
Individually and as the constituents of proteins, amino acids perform numerous and often essential functions. The current researchers have previously demonstrated clearly defined population subgroups based upon urinary amino acid profiles in chronic fatigue and pain patients, each group with specific nutritional requirements for amino acids. The same subgroups were also identified in healthy individuals with profiles differing from the patient groups only in the degree of excess or depletion of amino acids. The current project aims to determine whether distinct subgroups can be identified in healthy individuals reporting sub-health on the basis of urinary amino acid patterns. Sub-health is typically seen as a reduction in energy levels, change in sleeping patterns, increased incidence of viral infections and a loss of vitality with no defined disease being diagnosed. It can be defined as a chronic condition of deteriorated physiological function between health and illness. The project also aims to assess the ability of amino acid supplementation to improve the general well-being of individuals experiencing sub-health based upon membership of the subgroups identified in stage one. The current researchers have developed a nutritional formulation to alleviate fatigue containing a complex range of amino acids. The study will trial the amino acid supplement in subgroups of healthy individuals reporting sub-health. The study will involve a large group of adults reporting fatigue and sub-health but who are free from any significant medical or mental illness. Prior to supplementation all participants will be required to provide a urine sample and to complete general health and fatigue questionnaires. Urinary amino acid excretion patterns will be assessed with the aim of identifying subgroups based upon differential amino acid homeostasis. Once the subgroups have been differentiated, smaller groups of twenty individuals from each subgroup will trial the supplement for 30 days. At the completion of the trial participants will provide another urine sample and again complete the general health and fatigue questionnaires. General health, fatigue and urinary amino acid levels will be analysed to determine whether supplementation can bring about changes at both a symptom and biological level. It is believed that participants will derive significant benefits such as reduced fatigue but that the response to supplementation will be influenced by amino acid profile subgroup membership. This study will determine whether readily identifiable amino acid profile subgroups exist, each with specific amino acid requirements, allowing for the development of more effective dietary supplements in the future. The project’s hypotheses are as follows: 1. It is possible to identify major subtypes of amino acid homeostasis in a population. 2. Amino acid supplementation is capable of alleviating symptoms of sub-health and the symptoms and degree of alleviation will be determined by membership of subgroups based upon amino acid homeostasis.
Interventions
The first stage of the study has been designed in order to provide evidence that phenotypic subsets exist within the sub-health population which may indicate differential nutritional requirements. Initially 400 participants will be recruited to allow for sub-grouping based upon differential amino acid homeostasis. From each subgroup 20 individuals will be asked to participate in the amino acid supplement trial. It is envisaged that 100-120 individuals will participate in the second stage however this will be depend upon the number of sub-groups identified after stage 1. Participants from stage 1 will be randomly chosen for inclusion in stage 2, although age- and sex-matching will be undertaken. Arm 1 (project involves two stages however Arm 1 does not involve a “treatment”) - Metabolic Profiling: Healthy adults reporting symptoms of sub-health will be asked to complete a medical history questionnaire (medical history, age, sex, ethnicity, medications, whether pregnant) in part to determine eligibility. If eligible, participants will be asked to complete a questionnaire regarding 86 symptoms including fatigue, mood, immune dysfunction, neurocognition etc. Complete Chalder Fatigue Scale questionnaire (11 questions). List current medications/supplements. They will be asked to collect at home a fasted first-morning (after 5am) urine sample. Fasted indicates participant cannot eat after 10pm the night before collection and should only drink a small amount of water if necessary. Urine samples will be assessed for amino acid content. Arm 2 – Amino Acid Supplement Trial: Individuals randomly chosen from Arm 1 of the study will be asked to take 20g of an amino acid supplement once daily for 30 days. The supplement, in the form of a powder may be mixed in water. The supplement, Fatigue Reviva, is a food supplement material and is produced by TOP Nutrition Pty Ltd. The morning following the final day of the trial participants will again be required to complete the symptom and fatigue questionnaires; provide a urine sample; answer a number of open-ended questions regarding experience of using the supplement and list medications/supplements.
Sponsors
Study design
Eligibility
Inclusion criteria
Adults suffering from symptoms of sub-health (tiredness, fatigue, lack of energy, sub-optimal levels of performance). Free from significant medical/psychiatric conditions. Must not be pregnant.
Exclusion criteria
Previously diagnosed with a significant medical or psychiatric condition. Pregnancy Intellectual disability Less than 18 years of age Dependent on significant medical care