Oral Rehydration Solution and Dehydration Recovery

NCT06368765 | Terminated

• 1 other identifier: BL72
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dehydration

Outcome Measures

Primary Outcomes (1)

• Plasma Volume

  Calculated Change in Plasma Volume

  Through Study completion, an average of 2 weeks

Secondary Outcomes (6)

• Body Mass

  Through Study completion, an average of 2 weeks

• Hydration Status Urine

  Through Study completion, an average of 2 weeks

• Blood Biomarker - Plasma Osmolality

  Through Study completion, an average of 2 weeks

• Blood Biomarker - Plasma Electrolyte Concentration

  Through Study completion, an average of 2 weeks

• Blood Biomarker - Plasma Glucose Concentration

  Through Study completion, an average of 2 weeks

Other Outcomes (12)

• Body Composition

  Through Study completion, an average of 2 weeks

• Reaction Time

  Through Study completion, an average of 2 weeks

• Handgrip Strength

  Through Study completion, an average of 2 weeks

Study Arms (2)

Oral Rehydration Solution

EXPERIMENTAL

Oral rehydration solution with carbohydrate

Other: Oral Rehydration Solution (ORS)

Water

EXPERIMENTAL

Water with flavor

Other: Water

Interventions

Oral Rehydration Solution (ORS) OTHER

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

Oral Rehydration Solution

Water OTHER

Participants will be administered water during one of the study visits

Water

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Nutrition: lead

Study Sites (1)

Finlay Research

Miami, Florida, 33126, United States

Location

MeSH Terms

Conditions

Dehydration

Interventions

World Health Organization oral rehydration solution; Water

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Jennifer Williams

  Abbott Nutrition

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2024
• First Posted: April 16, 2024
• Study Start: July 8, 2024
• Primary Completion: October 17, 2024
• Study Completion: October 17, 2024
• Last Updated: February 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)