Randomized clinical trial in which 160 participants (80 men, 80 women) will be assigned to one of two groups (40 participants per group), to determine the effects of isotonic drink on different health parameters, following published recommendations. Subjects will be electronically randomized by block design into two arms: an experimental group: isotonic drink and a control group (placebo): normal water.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
240
Intake of natural isotonic drink based on 20% Atlantic sea water, mixed with lemon and stevia.
Intake of natural mineral water
Alejandro Martínez Rodríguez
Elche, Alicante, Spain
Body composition
Measurement of body composition using bioimpedance with the Biodyxpert device.
Time frame: 12 weeks
Body composition
Measurement of body composition through anthropometry.
Time frame: 12 weeks
Blood pressure
Measurement of systolic and diastolic blood pressure. Using an OMROM upper arm blood pressure monitor.
Time frame: 12 weeks
Perception of quality of life
Using a Quality of Life Questionnaire (SF36). Quality of Life Questionnaire is a comprehensive questionnaire that covers various attributes of an individuals life. It covers a variety of demographic questions to get better quality data and information before analyzing the quality of life of an individual.The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
Time frame: 12 weeks
Perceived stress
Measurement of perceived stress using the Perceived Stress Scale (PSS)
Time frame: 12 weeks
BLOOD GLUCOSE
Glucose levels in blood by blood analysis.
Time frame: 12 weeks
BLOOD INSULIN
Insulin levels in blood by blood analysis.
Time frame: 12 weeks
BLOOD LIPID PORFILE
Cholesterol and triglycerides levels in blood.
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Time frame: 12 weeks
Specific color of urine
Time frame: 12 weeks
Specific gravity of urine
Time frame: 12 weeks
Minerals in urine
K+ (Potassium), Na+ (Sodium), Mg2+ (Magnesium), Ca2+ (Calcium)
Time frame: 12 weeks
Urinary pH
Time frame: 12 weeks
Mood States Profile
The POMS (Profile of Mood States) questionnaire is a psychological assessment tool widely used to measure mood states. It consists of a series of words or phrases that describe feelings and emotions. Participants are asked to rate each item on a scale, indicating how well it represents their mood over a specific period. The POMS measures six different mood dimensions: Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment. It's commonly used in clinical settings, as well as in research studies, to assess the impact of various treatments or interventions on mood states. The POMS is valued for its sensitivity in detecting mood changes over time and its ability to differentiate between various mood states.
Time frame: 12 weeks
Evaluation of constipation symptoms by the patient
The PAC-SYM (Patient Assessment of Constipation Symptoms) is a self-report questionnaire designed to evaluate the symptoms of constipation from the patient's perspective. It is commonly used in clinical research and practice to assess the severity and impact of constipation symptoms. The questionnaire includes a series of items that ask patients to rate the frequency and severity of their constipation-related symptoms, such as abdominal discomfort, straining, and incomplete bowel movements.
Time frame: 12 weeks
Evaluation of the quality of life of patients with constipation (PAC-QOL)
The PAC-QOL (Patient Assessment of Constipation Quality of Life) questionnaire is a specialized tool designed to assess the quality of life in individuals suffering from constipation. It is a patient-reported outcome measure that focuses on how constipation affects a person's daily life, well-being, and overall health.
Time frame: 12 weeks
Sleep quality
Measurement of sleep quality using the Pittsburgh sleep quality index.
Time frame: 12 weeks
Liver biomarkers
Measurement of liver biomarkers through a blood test; Aspartate aminotransferase (AST or GOT), Alanine aminotransferase (ALT or GPT) and Bilirubin
Time frame: 12 weeks
Microbiome Indices
Microbiome indices through stool sample; Firmicutes/Bacteroidetes, Bacteroides/Prevotella, Enterobacteria/Enterococcus, Clostridium coccoides/perfringens
Time frame: 12 weeks
Weight
Weight evaluation using a digital scale
Time frame: 12 weeks