Effect of a Sugar-free Isotonic Drink on Different Health Bioparameters
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Alicante
- Enrollment
- 240
- Locations
- 1
- Primary Endpoint
- Minerals in urine
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
Participants will not be aware that there are other people consuming a different type of drink than theirs. The person analyzing the results will also be unaware. However, the researchers will be aware because they need to control the supply.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •men and women aged >18 years;
- •body mass index (BMI) of 18 to 25 kg/m^2;
Exclusion Criteria
- •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.
Arms & Interventions
CONTROL GROUP
Volunteer participants who will drink water
Intervention: PLACEBO (Other)
ISOTONIC DRINK GROUP
Volunteer participants who will drink Natural isotonic drink based on 20% Atlantic sea water, mixed with lemon and stevia.
Intervention: INTAKE OF ISOTONIC DRINK (Other)
Outcomes
Primary Outcomes
Minerals in urine
Time Frame: 12 weeks
K+ (Potassium), Na+ (Sodium), Mg2+ (Magnesium), Ca2+ (Calcium)
Perceived stress
Time Frame: 12 weeks
Measurement of perceived stress using the Perceived Stress Scale (PSS)
Body composition
Time Frame: 12 weeks
Measurement of body composition using bioimpedance with the Biodyxpert device.
Specific gravity of urine
Time Frame: 12 weeks
Blood pressure
Time Frame: 12 weeks
Measurement of systolic and diastolic blood pressure. Using an OMROM upper arm blood pressure monitor.
BLOOD GLUCOSE
Time Frame: 12 weeks
Glucose levels in blood by blood analysis.
Specific color of urine
Time Frame: 12 weeks
Urinary pH
Time Frame: 12 weeks
Evaluation of the quality of life of patients with constipation (PAC-QOL)
Time Frame: 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
Time Frame: 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.
Mood States Profile
Time Frame: 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.
BLOOD INSULIN
Time Frame: 12 weeks
Insulin levels in blood by blood analysis.
BLOOD LIPID PORFILE
Time Frame: 12 weeks
Cholesterol and triglycerides levels in blood.
Evaluation of constipation symptoms by the patient
Time Frame: 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
Time Frame: 12 weeks
Microbiome indices through stool sample; Firmicutes/Bacteroidetes, Bacteroides/Prevotella, Enterobacteria/Enterococcus, Clostridium coccoides/perfringens
Sleep quality
Time Frame: 12 weeks
Measurement of sleep quality using the Pittsburgh sleep quality index.
Liver biomarkers
Time Frame: 12 weeks
Measurement of liver biomarkers through a blood test; Aspartate aminotransferase (AST or GOT), Alanine aminotransferase (ALT or GPT) and Bilirubin
Secondary Outcomes
- Weight(12 weeks)
Investigators
Prof. Dr. Alejandro Martínez-Rodríguez
Full professor
University of Alicante