Efficacy of a Water Intervention in Institutionalized Aged Population.
NCT Number: NCT06497426
Acronym: FIS22-AC
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Muscle Loss
Interventions: OTHER: Study intervention
Sponsor: Consorci Sanitari del Maresme
Sex: ALL
Age: OLDER_ADULT
Enrollment: 70
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: PREVENTION
Start Date: 2023-06-15
Completion Date: 2025-06-15
Locations: Consorci Sanitari del Maresme, Mataró, Barcelona, 08304, Spain

Summary:
Background: As a person ages, there is a decrease in the body's ability to respond to feeding and exercise anabolic stimuli and to produce muscle proteins. Causes of this anabolic resistance in aged population are not well known. Total body water also decreases with age and has been related with muscle mass, strength and performance.

Objective: The aim of this study is to assess the effect of a water intervention on anabolic resistance and on some physiological adaptive response to water loss indicators in institutionalized aged population. Methodology: Design and population: randomized controlled trial with two parallel arms in ≥65-year-old institutionalized subjects. Study intervention: supervised water ingestion (30-35 ml/kg/day) during 7 consecutive days. Control intervention: usual care (water ingestion ad libitum). Main outcome measures: a)anabolic resistance (nitrogen balance, 3-methyl-histindine, urea excretion, plasmatic and urinary urea and urea/high index), b) indicators of physiological adaptive mechanism to water conservation (copeptin, sympathetic tone, inflammatory indicators, anabalic and catabolic hormones), c)muscle mass (according to bioimpedance analysis), grip strength (JAMAR dynamometer), sarcopenia (according to EWGSOP 2 criteria), and d) clinical recovery.

Controls and follow-up: at 1 week and hospital discharge.

Primary Outcome Measures: Nitrogen balance, Nitrogen balance (NB) measures the difference between nitrogen intake and the amount excreted in feces, urine, and sweat. Losing 13 more nitrogen than we consume in the diet would result in a negative NB. This situation indicates that the body is losing protein and does not have the adequate amount of nitrogen to build and repair cells and tissues., Baseline, 1 week of follow-up, 2 weeks of follow-up|Plasmatic and urinary urea concentration, an increase of both may suggest dehydration when there is no antecedent of renal failure, Baseline, 1 week of follow-up, 2 weeks of follow-up|Urea, Fractional excretion of urea, Baseline, 1 week of follow-up, 2 weeks of follow-up|Creatinine-height index, The creatinine-height index determines the relationship between the observed and expected creatinine clearance for an adult of the same age and height., Baseline, 1 week of follow-up, 2 weeks of follow-up
Secondary Outcome Measures: Inflammatory parameters, plasmatic CRP and IL-6 levels, Baseline, 1 week of follow-up, 2 weeks of follow-up|Sympathetic tone, plasmatic norepinephrine levels, Baseline, 1 week of follow-up, 2 weeks of follow-up|Plasma copeptin levels, Copeptin, a 39-amino acid-long peptide derived from the c-terminus of pre-pro-hormone of AVP, neurophysin II, and copeptin, is co-released with AVP from the hypothalamus and is considered a reliable AVP surrogate, Baseline, 1 week of follow-up, 2 weeks of follow-up|Plasmatic anabolic hormones, Testosterone, GH, IGF-1, Insulin, Baseline, 1 week of follow-up, 2 weeks of follow-up|Plasmatic catabolic hormones, cortisol, ACTH, Baseline, 1 week of follow-up, 2 weeks of follow-up|Plasmatic osmolarity, Plasmatic osmolarity, Baseline, 1 week of follow-up, 2 weeks of follow-up|Urinary osmolarity, Urinary osmolarity, Baseline, 1 week of follow-up, 2 weeks of follow-up|BIA hydration parameters, Total body water, extracellular water (ECW) and intracellular water (ICW), Baseline, 1 week of follow-up, 2 weeks of follow-up