Oral Rehydration Solution and Dehydration Recovery

NCT ID: NCT06368765

Last Updated: 2025-02-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-08
• Study Completion Date: 2024-10-17

Brief Summary

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

Conditions

Dehydration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Oral Rehydration Solution

Oral rehydration solution with carbohydrate

Group Type: EXPERIMENTAL

Oral Rehydration Solution (ORS)

Intervention Type: OTHER

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

Water

Water with flavor

Group Type: EXPERIMENTAL

Water

Intervention Type: OTHER

Participants will be administered water during one of the study visits

Interventions

Oral Rehydration Solution (ORS)

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

Intervention Type: OTHER

Water

Participants will be administered water during one of the study visits

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Abbott Nutrition

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jennifer Williams

Role: STUDY_CHAIR

Abbott Nutrition

Locations

Finlay Research

Miami, Florida, United States

Countries

United States

Other Identifiers

BL72

Identifier Type: -

Identifier Source: org_study_id