Clinical trial NCT06184997: Effect of a Sugar-free Isotonic Drink on Different Health Bioparameters
Official title: Effect of a Sugar-free Isotonic Drink on Different Health Bioparameters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: University of Alicante
Sponsor class: OTHER
First posted: 2023-12-29
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: OTHER

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.


Eligibility criteria: Inclusion Criteria:

* men and women aged \&amp;gt;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\&amp;#39;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.

Primary outcomes:
measure: Body composition
timeFrame: 12 weeks
measure: Body composition
timeFrame: 12 weeks
measure: Blood pressure
timeFrame: 12 weeks
measure: Perception of quality of life
timeFrame: 12 weeks
measure: Perceived stress
timeFrame: 12 weeks
measure: BLOOD GLUCOSE
timeFrame: 12 weeks
measure: BLOOD INSULIN
timeFrame: 12 weeks
measure: BLOOD LIPID PORFILE
timeFrame: 12 weeks
measure: Specific color of urine
timeFrame: 12 weeks
measure: Specific gravity of urine
timeFrame: 12 weeks
measure: Minerals in urine
timeFrame: 12 weeks
measure: Urinary pH
timeFrame: 12 weeks
measure: Mood States Profile
timeFrame: 12 weeks
measure: Evaluation of constipation symptoms by the patient
timeFrame: 12 weeks
measure: Evaluation of the quality of life of patients with constipation (PAC-QOL)
timeFrame: 12 weeks
measure: Sleep quality
timeFrame: 12 weeks
measure: Liver biomarkers
timeFrame: 12 weeks
measure: Microbiome Indices
timeFrame: 12 weeks
Secondary outcomes:
measure: Weight
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Elche
country: Spain
facility: Alejandro Martínez Rodríguez
state: Alicante
Study officials:
References: