Oral Rehydration Solution and Dehydration Recovery

Dehydration Clinical Trial

Official title:

Effects of Oral Rehydration Solution on Dehydration Recovery in Adults

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06368765
• Other study ID #: BL72
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: November 2024

Study information

• Verified date: April 2024
• Source: Abbott Nutrition
• Contact: Kristen DeLuca
• Phone: 16145653522
• Email: kristen.deluca[@]abbott.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dehydration

Intervention

Other:
• Oral Rehydration Solution (ORS)
Participants will be administered the ORS during one of the study visits
• Water
Participants will be administered water during one of the study visits

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Nutrition

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Body Composition	Change in Body Composition as measured by Bioimpedance Analyzer	Through Study completion, an average of 2 weeks
Other	Reaction Time	Change in Reaction Time	Through Study completion, an average of 2 weeks
Other	Handgrip Strength	Change in handgrip strength as measured by hand dynamometer	Through Study completion, an average of 2 weeks
Other	Urine Volume	Urine Collection	Through Study completion, an average of 2 weeks
Other	Hydration Status Saliva	Change in Saliva Osmolality	Through Study completion, an average of 2 weeks
Other	Heart Rate	Changes in heart rate as measured beats per minute	Through Study completion, an average of 2 weeks
Other	Blood Pressure	Change in Blood Pressure as measured systolic/diastolic mm Hg	Through Study completion, an average of 2 weeks
Other	Thirst Sensation Scale	Participant completed categorical scale based on "not thirsty at all" to "very, very thirsty"	Through Study completion, an average of 2 weeks
Other	Gagge Thermal Scale	Change in participant reported comfort (scored 1 Comfortable to 4 Very Uncomfortable) and sensation (scored 1 Cold to 7 Hot)	Through Study completion, an average of 2 weeks
Other	Urine Color	Participant reported color match of 8 possible categories.	Through Study completion, an average of 2 weeks
Other	Palatability	3 participant completed palatability questions on Likert scale scored from 1 (Dislike/Not at all) to 9 (Extremely)	Through Study completion, an average of 2 weeks
Other	Adverse Events	Participant Experienced Adverse Events	Through Study completion, an average of 2 weeks
Primary	Plasma Volume	Calculated Change in Plasma Volume	Through Study completion, an average of 2 weeks
Secondary	Body Mass	Change in Body Mass	Through Study completion, an average of 2 weeks
Secondary	Hydration Status Urine	Change in Urine Osmolality	Through Study completion, an average of 2 weeks
Secondary	Blood Biomarker - Plasma Osmolality	Change in Plasma Osmolality	Through Study completion, an average of 2 weeks
Secondary	Blood Biomarker - Plasma Electrolyte Concentration	Change in Electrolyte Concentration	Through Study completion, an average of 2 weeks
Secondary	Blood Biomarker - Plasma Glucose Concentration	Change in Plasma Glucose Concentration	Through Study completion, an average of 2 weeks
Secondary	Body Temperature	Change in degrees Celsius	Through Study Completion, as average of 2 weeks