Clinical trial NCT06368765: Oral Rehydration Solution and Dehydration Recovery
Official title: Effects of Oral Rehydration Solution on Dehydration Recovery in Adults
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Dehydration
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2024-04-16
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This is a prospective, randomized, controlled, blinded, crossover, study to evaluate the effects of an oral hydration solution.


Eligibility criteria: Inclusion Criteria:

* Participant is 18 to 40 years of age.
* Participant has a body mass index (BMI) ≥ 18 and ≤ 30 kg/m2
* Participant reports having a moderate to heavy sweat rate when physically exerted or in extreme heat.
* Participant is male or non-pregnant, non-lactating female, at least 6 weeks postpartum prior to screening visit.
* Participant has a systolic blood pressure of \< 130 mm Hg and a diastolic blood pressure \< 90 mm Hg, without the use of anti-hypertensive medications.
* Participant reports no predisposing cardiovascular conditions.
* If female, participant has a regular menstrual cycle.
* Participant is willing to consume grape-flavored beverages during the study.
* If participant is on chronic medication, the dosage must be constant for at least 2 months prior to first study visit and able to maintain medication type and dose throughout duration of study.
* Participant is weight-stable for the two months prior to screening visit
* Participant has voluntarily signed and dated an informed consent form (ICF), approved by an IRB, and provided applicable privacy regulation authorization prior to any participation in the study.
* Participant has no known intolerance or allergy to ingredients in study products.
* Participant is willing to refrain from using saunas or hot tubs for the duration of the study.
* Participant is able and willing to follow study procedures and complete any forms or assessments needed during the study.

Exclusion Criteria:

* Participant is a current, and including the past 8 weeks, participant in a weight-conscious sport such as but not limited to wrestling, powerlifting, boxing, rowing, gymnastics or any martial arts, with participation defined as ≥ 3x weekly training.
* Participant is currently, and for the past 4 weeks or longer: running \>40 miles per week on average, cycling \>80 miles per week on average or swimming \>20,000 yards per week on average.
* Participant is participating in another study that has not been approved as a concomitant study
* Participant has used a sauna in the past 4 weeks.
* Participant uses any form of tobacco or nicotine, or other controlled substance not prescribed by a physician.
* Participant has previous history with heat illness or injury that resulted in a visit to a medical center in the past 12 months.
* Participant has an eating disorder, severe dementia or delirium, history of significant neurological or psychiatric disorder, alcoholism, substance abuse or other conditions that may interfere with study product consumption or compliance with study protocol procedures.
* Participant is currently taking or has taken antibiotics within 6 weeks of enrollment.
* Participant is currently taking or has taken a diuretic within 1 week of enrollment.
* Participant has been diagnosed with the following according to self-report:

  * Recent or current acute or chronic infections including but not restricted to respiratory infections, diarrhea, Hepatitis B or C, HIV infection or tuberculosis
  * Severe gastrointestinal disorders such as celiac disease, short bowel syndrome, pancreatic insufficiency, or cystic fibrosis
  * Metabolic \[including diabetes\], renal, hepatic, or respiratory disease
  * Active malignancy
  * Polycystic ovary disease
  * Any other clinically significant medical condition, which in the investigator's opinion, makes him or her unsuitable for inclusion in the study.

Primary outcomes:
measure: Plasma Volume
timeFrame: Through Study completion, an average of 2 weeks
Secondary outcomes:
measure: Body Mass
timeFrame: Through Study completion, an average of 2 weeks
measure: Hydration Status Urine
timeFrame: Through Study completion, an average of 2 weeks
measure: Blood Biomarker - Plasma Osmolality
timeFrame: Through Study completion, an average of 2 weeks
measure: Blood Biomarker - Plasma Electrolyte Concentration
timeFrame: Through Study completion, an average of 2 weeks
measure: Blood Biomarker - Plasma Glucose Concentration
timeFrame: Through Study completion, an average of 2 weeks
measure: Body Temperature
timeFrame: Through Study Completion, as average of 2 weeks
Other outcomes:
measure: Body Composition
timeFrame: Through Study completion, an average of 2 weeks
measure: Reaction Time
timeFrame: Through Study completion, an average of 2 weeks
measure: Handgrip Strength
timeFrame: Through Study completion, an average of 2 weeks
measure: Urine Volume
timeFrame: Through Study completion, an average of 2 weeks
measure: Hydration Status Saliva
timeFrame: Through Study completion, an average of 2 weeks
measure: Heart Rate
timeFrame: Through Study completion, an average of 2 weeks
measure: Blood Pressure
timeFrame: Through Study completion, an average of 2 weeks
measure: Thirst Sensation Scale
timeFrame: Through Study completion, an average of 2 weeks
measure: Gagge Thermal Scale
timeFrame: Through Study completion, an average of 2 weeks
measure: Urine Color
timeFrame: Through Study completion, an average of 2 weeks
measure: Palatability
timeFrame: Through Study completion, an average of 2 weeks
measure: Adverse Events
timeFrame: Through Study completion, an average of 2 weeks
Locations:
city: Miami
country: United States
facility: Finlay Research
state: Florida
Study officials:
affiliation: Abbott Nutrition
name: Jennifer Williams
role: STUDY_CHAIR
References: