Effect of a Sugar-free Isotonic Drink on Different Health Bioparameters
- Conditions
- Healthy Volunteers
- Interventions
- Other: INTAKE OF ISOTONIC DRINKOther: PLACEBO
- Registration Number
- NCT06184997
- Lead Sponsor
- University of Alicante
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 240
- men and women aged >18 years;
- body mass index (BMI) of 18 to 25 kg/m^2;
- individuals who have taken medication up to 3 months before the start of the study or supplements during the study;
- individuals with a history of gastrointestinal pathology or disorder such as duodenal ulcer, chronic colitis, or chronic inflammatory disease/surgery of the gastrointestinal tract (Crohn's disease, ulcerative colitis), celiac disease, or irritable bowel syndrome;
- individuals with serious acute or chronic diseases, treatments, or recent surgery;
- individuals with a report of serum levels of aspartate aminotransferase (AST), alanine aminotransferase (ALT), or gamma-glutamyl transferase (GGT) above the upper limit of the reference interval.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ISOTONIC DRINK GROUP INTAKE OF ISOTONIC DRINK Volunteer participants who will drink Natural isotonic drink based on 20% Atlantic sea water, mixed with lemon and stevia. CONTROL GROUP PLACEBO Volunteer participants who will drink water
- Primary Outcome Measures
Name Time Method Specific gravity of urine 12 weeks Blood pressure 12 weeks Measurement of systolic and diastolic blood pressure. Using an OMROM upper arm blood pressure monitor.
BLOOD GLUCOSE 12 weeks Glucose levels in blood by blood analysis.
Body composition 12 weeks Measurement of body composition through anthropometry.
Specific color of urine 12 weeks Urinary pH 12 weeks Evaluation of the quality of life of patients with constipation (PAC-QOL) 12 weeks 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.
Perception of quality of life 12 weeks 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.
Minerals in urine 12 weeks K+ (Potassium), Na+ (Sodium), Mg2+ (Magnesium), Ca2+ (Calcium)
Mood States Profile 12 weeks 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.
Perceived stress 12 weeks Measurement of perceived stress using the Perceived Stress Scale (PSS)
BLOOD INSULIN 12 weeks Insulin levels in blood by blood analysis.
BLOOD LIPID PORFILE 12 weeks Cholesterol and triglycerides levels in blood.
Evaluation of constipation symptoms by the patient 12 weeks 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.
Microbiome Indices 12 weeks Microbiome indices through stool sample; Firmicutes/Bacteroidetes, Bacteroides/Prevotella, Enterobacteria/Enterococcus, Clostridium coccoides/perfringens
Sleep quality 12 weeks Measurement of sleep quality using the Pittsburgh sleep quality index.
Liver biomarkers 12 weeks Measurement of liver biomarkers through a blood test; Aspartate aminotransferase (AST or GOT), Alanine aminotransferase (ALT or GPT) and Bilirubin
- Secondary Outcome Measures
Name Time Method Weight 12 weeks Weight evaluation using a digital scale
Trial Locations
- Locations (1)
Alejandro Martínez Rodríguez
🇪🇸Elche, Alicante, Spain