Effect of a Sugar-free Isotonic Drink on Different Health Bioparameters

Healthy Volunteers Clinical Trial

Official title:

Effect of a Sugar-free Isotonic Drink on Different Health Bioparameters

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06184997
• Other study ID #: UA-2023-10-03
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 8, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: University of Alicante
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 240
• Est. completion date: December 31, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Other:
• INTAKE OF ISOTONIC DRINK
Intake of natural isotonic drink based on 20% Atlantic sea water, mixed with lemon and stevia.
• PLACEBO
Intake of natural mineral water

Locations

Country	Name	City	State
Spain	Alejandro Martínez Rodríguez	Elche	Alicante

Sponsors (1)

Lead Sponsor	Collaborator
University of Alicante

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body composition	Measurement of body composition using bioimpedance with the Biodyxpert device.	12 weeks
Primary	Body composition	Measurement of body composition through anthropometry.	12 weeks
Primary	Blood pressure	Measurement of systolic and diastolic blood pressure. Using an OMROM upper arm blood pressure monitor.	12 weeks
Primary	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.	12 weeks
Primary	Perceived stress	Measurement of perceived stress using the Perceived Stress Scale (PSS)	12 weeks
Primary	BLOOD GLUCOSE	Glucose levels in blood by blood analysis.	12 weeks
Primary	BLOOD INSULIN	Insulin levels in blood by blood analysis.	12 weeks
Primary	BLOOD LIPID PORFILE	Cholesterol and triglycerides levels in blood.	12 weeks
Primary	Specific color of urine		12 weeks
Primary	Specific gravity of urine		12 weeks
Primary	Minerals in urine	K+ (Potassium), Na+ (Sodium), Mg2+ (Magnesium), Ca2+ (Calcium)	12 weeks
Primary	Urinary pH		12 weeks
Primary	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.	12 weeks
Primary	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.	12 weeks
Primary	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.	12 weeks
Primary	Sleep quality	Measurement of sleep quality using the Pittsburgh sleep quality index.	12 weeks
Primary	Liver biomarkers	Measurement of liver biomarkers through a blood test; Aspartate aminotransferase (AST or GOT), Alanine aminotransferase (ALT or GPT) and Bilirubin	12 weeks
Primary	Microbiome Indices	Microbiome indices through stool sample; Firmicutes/Bacteroidetes, Bacteroides/Prevotella, Enterobacteria/Enterococcus, Clostridium coccoides/perfringens	12 weeks
Secondary	Weight	Weight evaluation using a digital scale	12 weeks