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

NCT06184997 | Completed

• 1 other identifier: UA-2023-10-03
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (18)

• Body composition

  Measurement of body composition using bioimpedance with the Biodyxpert device.

  12 weeks

• Body composition

  Measurement of body composition through anthropometry.

  12 weeks

• Blood pressure

  Measurement of systolic and diastolic blood pressure. Using an OMROM upper arm blood pressure monitor.

  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.

  12 weeks

• Perceived stress

  Measurement of perceived stress using the Perceived Stress Scale (PSS)

  12 weeks

• BLOOD GLUCOSE

  Glucose levels in blood by blood analysis.

  12 weeks

• BLOOD INSULIN

  Insulin levels in blood by blood analysis.

  12 weeks

• BLOOD LIPID PORFILE

  Cholesterol and triglycerides levels in blood.

  12 weeks

• Specific color of urine

  12 weeks

• Specific gravity of urine

  12 weeks

• Minerals in urine

  K+ (Potassium), Na+ (Sodium), Mg2+ (Magnesium), Ca2+ (Calcium)

  12 weeks

• Urinary pH

  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.

  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.

  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.

  12 weeks

• Sleep quality

  Measurement of sleep quality using the Pittsburgh sleep quality index.

  12 weeks

• Liver biomarkers

  Measurement of liver biomarkers through a blood test; Aspartate aminotransferase (AST or GOT), Alanine aminotransferase (ALT or GPT) and Bilirubin

  12 weeks

• Microbiome Indices

  Microbiome indices through stool sample; Firmicutes/Bacteroidetes, Bacteroides/Prevotella, Enterobacteria/Enterococcus, Clostridium coccoides/perfringens

  12 weeks

Secondary Outcomes (1)

• Weight

  12 weeks

Study Arms (2)

CONTROL GROUP

PLACEBO COMPARATOR

Volunteer participants who will drink water

Other: PLACEBO

ISOTONIC DRINK GROUP

EXPERIMENTAL

Volunteer participants who will drink Natural isotonic drink based on 20% Atlantic sea water, mixed with lemon and stevia.

Other: INTAKE OF ISOTONIC DRINK

Interventions

INTAKE OF ISOTONIC DRINK OTHER

Intake of natural isotonic drink based on 20% Atlantic sea water, mixed with lemon and stevia.

ISOTONIC DRINK GROUP

PLACEBO OTHER

Intake of natural mineral water

CONTROL GROUP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• men and women aged \>18 years;
• body mass index (BMI) of 18 to 25 kg/m\^2;

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alicante: lead

Study Sites (1)

Alejandro Martínez Rodríguez

Elche, Alicante, 03203, Spain

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full professor

Model Details: Participants will be assigned to group A (water, placebo) or group B (sugar-free isotonic drink), and will be instructed to consume 265 ml of water or 265 ml of sugar-free isotonic drink, respectively, every day for 12 weeks. During the study period, participants will be advised to maintain their usual diet and physical activity.

Study Record Dates

• First Submitted: December 14, 2023
• First Posted: December 29, 2023
• Study Start: January 8, 2024
• Primary Completion: July 1, 2024
• Study Completion: December 31, 2024
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)