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OpenTrials
Completed

NCT Number: NCT06130475

Oral Rehydration Solution in Healthy Adults

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

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Central Florida

Orlando, Florida, 32816, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 <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 enrollment 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 or recent (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:
  • 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

Treatment and study plan

Oral Rehydration Solution (ORS)

Other

Participants will be administered the ORS during one of the study visits

Water

Other

Participants will be administered water during one of the study visits

Primary outcomes

  1. Plasma Volume

    Time frame: Through Study completion, an average of 2 weeks

    Calculated Change in Plasma Volume

Secondary outcomes

  1. Body Mass

    Time frame: Through Study completion, an average of 2 weeks

    Body Mass Loss

  2. Hydration Status Urine

    Time frame: Through Study completion, an average of 2 weeks

    Change in Urine Osmolality

  3. Blood Biomarker - Plasma Osmolality

    Time frame: Through Study completion, an average of 2 weeks

    Change in Plasma Osmolality

  4. Blood Biomarker - Plasma Electrolyte Concentration

    Time frame: Through Study completion, an average of 2 weeks

    Change in Electrolyte Concentration

  5. Blood Biomarker - Glucose Concentration

    Time frame: Through Study completion, an average of 2 weeks

    Change in Plasma Glucose Concentration

  6. Body Temperature

    Time frame: Through Study completion, an average of 2 weeks

    Change in degrees Celsius

Other outcomes

  1. Body Fat

    Time frame: Through Study completion, an average of 2 weeks

    Change in Body Fat Composition as measured by Bioimpedance Analyzer

  2. Body Water

    Time frame: Through Study completion, an average of 2 weeks

    Change in Body Water as measured by Bioimpedance Analyzer

  3. Reaction Time

    Time frame: Through Study completion, an average of 2 weeks

    Change in Reaction Time

  4. Handgrip Strength

    Time frame: Through Study completion, an average of 2 weeks

    Change in Handgrip Strength measured via Hand Dynamometer

  5. Urine Volume

    Time frame: Through Study completion, an average of 2 weeks

    Urine Collection

  6. Hydration Status Saliva

    Time frame: Through Study completion, an average of 2 weeks

    Change in Saliva Osmolality

  7. Heart Rate

    Time frame: Through Study completion, an average of 2 weeks

    Change in Heart Rate as measured beats per minute

  8. Blood Pressure

    Time frame: Through Study completion, an average of 2 weeks

    Change in Blood Pressure as measured systolic/diastolic mm Hg

  9. Thirst Sensation Scale

    Time frame: Through Study completion, an average of 2 weeks

    Participant completed categorical scale based on "not thirsty at all" to "very, very thirsty"

  10. Gagge Thermal Scale

    Time frame: Through Study completion, an average of 2 weeks

    Change in participant reported comfort (scored 1 Comfortable to 4 Very Uncomfortable) and sensation (scored 1 Cold to 7 Hot)

  11. Palatability

    Time frame: Through Study completion, an average of 2 weeks

    3 participant completed palatability questions on Likert scale scored from 1 (Dislike/Not at all) to 9 (Extremely)

  12. Adverse Events

    Time frame: Through Study completion, an average of 2 weeks

    Participant Experienced Adverse Events

Sponsors and collaborators

Lead sponsor

Abbott Nutrition

Industry

Registry information

Official study title

Effects of Oral Rehydration Solution on Dehydration Recovery in Adults

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Nov 14, 2023
Registry last updated
Jan 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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