Heartburn. Gastroesophageal Reflux. Nausea. Eructation. Flatulence. Diarrhea
Conditions
Interventions
This is a non-inferiority, crossover, double-blind, placebo-controlled clinical trial. Each participant will undergo 4 visits to the research laboratory. These are based on: - Visit 1: After acceptanc
Sponsors
Centro Universitário São Camilo
Centro Universitário São Camilo
Eligibility
Age
18 Years to 59 Years
Inclusion criteria
Inclusion criteria: Adult men and women; aged between 18 and 59 years; with experience in long-duration exercises (running over 21 km) for at least 1 year
Exclusion criteria
Exclusion criteria: People with limitations in their respiratory or cardiovascular systems; who use ergogenic supplements chronically (e.g., beta-alanine and creatine); who use hormones or medications that modify physical performance; or who have any muscle injury that prevents them from performing the performance test; people with gastrointestinal diseases (e.g., irritable bowel syndrome or short bowel syndrome, Crohn's disease, among others); people who use prebiotic, probiotic, synbiotic supplements or use medications such as antibiotics, laxatives, antidiarrheals, antiemetics, antacids, or any substances that affect the gastrointestinal tract.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assess the perception of effort using the Borg scale, which ranges from 6 to 20 to observe how tired an individual is, with 6 corresponding to no effort and 20 to maximum effort. The outcome will be determined by comparing the effort at each visit.;The occurrence and intensity of gastrointestinal discomfort in participants will be assessed before and after the intervention. The outcome will be measured using the Gastrointestinal Symptom Rating Scale (GSRS), translated and validated for Portuguese, at pre- and post-intervention time points. Additionally, a visual analog scale (VAS) from 0 to 10 will be used to assess gastrointestinal symptoms. A change in the outcome will be considered when differences are observed in the GSRS scores between the assessed time points, as well as variations in the VAS score, where 0 corresponds to no symptoms and 10 to extremely severe symptoms, with statistical analysis considering significance at p < 0.05. | — |
Secondary
| Measure | Time frame |
|---|---|
| Assess the participants' preference for the carbohydrate gel regarding its sensory characteristics and digestibility. The outcome will be evaluated through the use of a Likert-type scale, on which participants will assign scores from 0 to 10 for the following aspects: consistency, taste, viscosity, and ease of digestion of the gel. Greater preference will be considered observed when higher scores are noted in the evaluations, with the results analyzed as continuous variables, where higher values indicate better acceptance. Differences between the gels will be considered significant when p < 0.05.;Assess the glycemic response of participants at different moments of the experimental protocol. The outcome will be measured through capillary blood glucose using an Accu-Chek® glucose self-monitor, via a finger prick to obtain a drop of blood. Three measurements will be taken at each evaluation time: before the standardized meal, 1 hour after the meal, before the start of the test, at each gel intake, 10 minutes after each intake, and 20 minutes after the end of the test. Fingers from the hand will be alternated throughout the protocol, with lancets changed at each collection, and the procedure will be performed using gloves by a qualified biomedical researcher. A change in glycemic response will be considered when variations in blood glucose values (mg/dL) are observed between the different evaluated moments. The results will be analyzed as continuous variables, considering a difference statistically significant when p < 0.05. | — |
Countries
Brazil
Contacts
Public ContactMarcus Dos Santos Quaresma
Centro Universitário São Camilo
Outcome results
None listed