Efficacy of a Water Intervention in Institutionalized Aged Population.

NCT06497426 | Completed

• 1 other identifier: 14/23
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Muscle Loss

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (8)

• Inflammatory parameters

  Baseline, 1 week of follow-up, 2 weeks of follow-up

• Sympathetic tone

  Baseline, 1 week of follow-up, 2 weeks of follow-up

• Plasma copeptin levels

  Baseline, 1 week of follow-up, 2 weeks of follow-up

• Plasmatic anabolic hormones

  Baseline, 1 week of follow-up, 2 weeks of follow-up

• Plasmatic catabolic hormones

  Baseline, 1 week of follow-up, 2 weeks of follow-up

Study Arms (2)

Water intake intervention

EXPERIMENTAL

During one week, participants will be asked to drink 30 (for women) or 35 (for men) ml of water/Kg of weight/day distributed homogeneously during the day. The water requirements of subjects with overweight will be calculated with the corrected weight using the Wilkens formula. Water will be provided in the form of 1L bottles and recommendations about the amount of water to intake will be individualized and indicated by a mark on the bottle. Water intake will be supervised by a nurse/nurse assistant/dietitian team to ensure adherence, and registered to assess intervention compliance. This water intake will be apart from usual meals. A dietitian will prepare the daily amount of mineral water in 1 liter bottles to facilitate the intervention supervision and compliance. All bottles will be identified by NID and date and will be retired and replaced every day at 8-9 am for compliance assessment. Participants will be asked to drink only the provided water.

Other: Study intervention

Control intervention

NO INTERVENTION

Usual clinical practice with no especial attention to hydration. Participants will be able to freely drink whatever they want (ad libitum). Participants in the control group will be provided with 2 bottles of 1L (2L of water) every day, and more water will be provided if requested. Daily water intake will also be quantified.

Interventions

Study intervention OTHER

Participants will be asked to drink water. Water intake will be supervised by a nurse/nurse assistant/dietitian team to ensure adherence, and registered to assess intervention compliance.

Water intake intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• subjects ≥65 years,
• institutionalized in a nursing home or in a convalescence unit in a socio sanitary center,
• who give their informed consent.

You may not qualify if:

• acute infectious disease,
• exacerbation of a chronic inflammatory disease
• less than 3 weeks from surgery,
• hepatic cirrhosis,
• chronic renal failure (with glomerular filtrate \<40),
• decompensate heart failure with edema in lower-limbs or acute pulmonary edema,
• active neoplasia,
• in palliative care or life expectancy less than 6 months,
• advanced dementia (GDS\>5),
• dysphagia,
• carrier of bilateral hip or knee prostheses, heart pacemaker
• serum therapy,
• Users of parenteral nutrition or nasogastric tube nutrition, and
• users of diapers (if they are not regular urinary tract carriers).

Sponsors & Collaborators

• Consorci Sanitari del Maresme: lead

Study Sites (1)

Consorci Sanitari del Maresme

Mataró, Barcelona, 08304, Spain

Location

MeSH Terms

Conditions

Muscular Atrophy

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2024
• First Posted: July 11, 2024
• Study Start: June 15, 2023
• Primary Completion: May 15, 2025
• Study Completion: June 15, 2025
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)