Oral Rehydration Solution in Healthy Adults

Last updated: January 13, 2025
Sponsor: Abbott Nutrition
Overall Status: Completed

Phase

N/A

Condition

Low Blood Pressure (Hypotension)

Treatment

Water

Oral Rehydration Solution (ORS)

Clinical Study ID

NCT06130475
BL68
  • Ages 18-40
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

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 orin extreme heat

  • Participant is male or non-pregnant, non-lactating female, at least 6 weekspostpartum prior to screening visit.

  • Participant has a systolic blood pressure <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 2months prior to enrollment and able to maintain medication, type and dose throughoutduration 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 priorto 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 ofthe study

  • Participant is able and willing to follow study procedures and complete any forms orassessments needed during the study

Exclusion

Exclusion Criteria:

  • Participant is a current or recent (the past 8 weeks) participant in aweight-conscious sport such as but not limited to wrestling, powerlifting, boxing,rowing, gymnastics or any martial arts, with participation defined as ≥ 3x weeklytraining

  • Participant is currently, and for the past 4 weeks or longer: running >40 miles perweek on average, cycling >80 miles per week on average or swimming >20,000 yards perweek on average

  • Participant is participating in another study that has not been approved as aconcomitant study

  • Participant has used a sauna in the past 4 weeks

  • Participant uses any form of tobacco or nicotine, or other controlled substance notprescribed by a physician

  • Participant has previous history with heat illness or injury that resulted in avisit to a medical center in the past 12 months

  • Participant has an eating disorder, severe dementia or delirium, history ofsignificant neurological or psychiatric disorder, alcoholism, substance abuse orother conditions that may interfere with study product consumption or compliancewith study protocol procedures

  • Participant is currently taking or has taken antibiotics within 6 weeks ofenrollment

  • Participant is currently taking or has taken a diuretic within 1 week of enrollment

  • Participant has been diagnosed with the following:

  • Acute or chronic infections including but not restricted to respiratoryinfections, 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'sopinion, makes him or her unsuitable for inclusion in the study

Study Design

Total Participants: 26
Treatment Group(s): 2
Primary Treatment: Water
Phase:
Study Start date:
March 15, 2024
Estimated Completion Date:
December 16, 2024

Connect with a study center

  • University of Central Florida

    Orlando, Florida 32816
    United States

    Site Not Available

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