HydrationNCT05569044
Oral Rehydration Solutions in Healthy Adult Athletes
A study testing Oral Rehydration Solution and Water in people with Hydration, run by Abbott Nutrition at 1 site in United States.
Trial summary
This is a prospective, randomized, controlled, crossover study to determine the benefits of adult athletes consuming an oral rehydration solution (ORS) with exercise. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Hydration
- What is being tested?
- Oral Rehydration Solution and Water
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Nov 2022to 18 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 to 30 years of age.
- Body fat percentage ≤17% for males and ≤24% for females.
- Male or non-pregnant, non-lactating female, at least 6 months postpartum prior to screening visit.
- Cycling VO2max in range of 45-53 mL O2/kg/min for males or 36-43 mL O2/kg/min for females.
- If female, participant has a regular menstrual cycle, >21 days and <35 days in length.
- Willing to consume grape-flavored beverages during the study.
Show all 12Show fewer
- If on chronic medication such as lipid-lowering, thyroid medication or hormone therapy, the dosage must be constant for at least 2 months prior to screening and baseline visit.
- Weight-stable for the two months prior to screening visit
- Voluntarily signed and dated an informed consent form (ICF), approved by an IRB, and provided Health Insurance Portability and Accountability Act (HIPAA) or other applicable privacy regulation authorization prior to any participation in the study.
- No known intolerance or allergy to ingredients in study products.
- Willing to refrain from using saunas or hot tubs for the duration of the study.
- Willing to follow study procedures and complete any forms or assessments needed during the study.
Who cannot join
- Athlete in a weight-conscious sport such as but not limited to wrestling, powerlifting, boxing, rowing, gymnastics or any martial arts.
- 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.
- Participating in another study that has not been approved as a concomitant study.
- Uses any form of tobacco or nicotine, or other controlled substance not prescribed by a physician.
- Previous history with heat illness or injury that resulted in a visit to a medical center.
- Experienced a serious musculoskeletal injury or surgery in the past 6 months that poses a risk during the trial, according to the study investigator.
Show all 16Show fewer
- 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.
- Currently taking or has taken antibiotics within 6 weeks of enrollment.
- Currently taking or has taken a diuretic within 1 week of enrollment.
- Diagnosed with the following according to medical records, self-report or according to the clinician's judgment:
- 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
- Cardiovascular, 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Oral Rehydration Solutions in Healthy Adult Athletes
This is a prospective, randomized, controlled, crossover study to determine the benefits of adult athletes consuming an oral rehydration solution (ORS) with exercise.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control GroupOther
No intervention
Oral Rehydration SolutionOther
Participants will be administered ORS during one of the study visits
WaterOther
Participants will be administered water during one of the study visits
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Other | No intervention Receives: Other: Control Group |
| Oral Rehydration Solution | Experimental | ORS with carbohydrate Receives: Other: Oral Rehydration Solution |
| Water | Experimental | Water with flavor Receives: Other: Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anaerobic Power
Change in cycling power
Measured: Through Study completion, an average of 6 weeks
Secondary outcomes (5)
Body Mass
Body mass loss
Measured: Through Study completion, an average of 6 weeks
Power Output
Mean cycling power
Measured: Through Study completion, an average of 6 weeks
Rating of Perceived Exertion (RPE)
Participant completed scale of perceived exertion from 6 (no exertion at all) to 20 (maximum exertion)
Measured: Through Study completion, an average of 6 weeks
Leg Strength
Measured by dynamometer
Measured: Through Study completion, an average of 6 weeks
Muscular Force
Change in isometric muscular contractions
Measured: Through Study completion, an average of 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2022
- Study start21 Nov 2022
- Primary completion18 Jun 2024
- Study completion18 Jun 2024
Why it stopped: Enrollment Challenges
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HydrationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jennifer Williams, MPH, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05569044
- Sponsor's protocol ID
- BL67
- Status last verified
- Sep 2024
- First submitted
- 19 Sep 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Oral Rehydration Solutions in Healthy Adult Athletes
- ClinicalTrials.gov ID
- NCT05569044
- Acronym / sponsor ID
- BL67
- Conditions
- Hydration
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment Challenges
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- 21 Nov 2022 (actual)
- Primary completion
- 18 Jun 2024 (actual)
- Study completion
- 18 Jun 2024 (actual)
- First posted
- 6 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, randomized, controlled, crossover study to determine the benefits of adult athletes consuming an oral rehydration solution (ORS) with exercise.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | Other | Other: Control GroupNo intervention |
| Oral Rehydration Solution | Experimental | Other: Oral Rehydration SolutionORS with carbohydrate |
| Water | Experimental | Other: WaterWater with flavor |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 18 to 30 years of age.
- Body fat percentage ≤17% for males and ≤24% for females.
- Male or non-pregnant, non-lactating female, at least 6 months postpartum prior to screening visit.
- Cycling VO2max in range of 45-53 mL O2/kg/min for males or 36-43 mL O2/kg/min for females.
- If female, participant has a regular menstrual cycle, >21 days and <35 days in length.
Key exclusion criteria (16 listed)
- Athlete in a weight-conscious sport such as but not limited to wrestling, powerlifting, boxing, rowing, gymnastics or any martial arts.
- 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.
- Participating in another study that has not been approved as a concomitant study.
- Uses any form of tobacco or nicotine, or other controlled substance not prescribed by a physician.
- Previous history with heat illness or injury that resulted in a visit to a medical center.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control GroupNo intervention | Other | Control Group |
| Oral Rehydration SolutionParticipants will be administered ORS during one of the study visits | Other | Oral Rehydration Solution |
| WaterParticipants will be administered water during one of the study visits | Other | Water |
Primary outcome
Anaerobic Power
Time frame: Through Study completion, an average of 6 weeks
Change in cycling power
5 secondary outcomes
Body Mass
Time frame: Through Study completion, an average of 6 weeks
Power Output
Time frame: Through Study completion, an average of 6 weeks
Rating of Perceived Exertion (RPE)
Time frame: Through Study completion, an average of 6 weeks
Leg Strength
Time frame: Through Study completion, an average of 6 weeks
Muscular Force
Time frame: Through Study completion, an average of 6 weeks
Results and safety
The study was stopped early (reason given: Enrollment Challenges). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
Related trials for Hydration
Not yet recruiting
Dietary Supplementation and Hydration
Hydration
Active, not recruiting
Xerosis and Use of Topical Moisturizer
Xerosis Due to Atopic Dermatitis
Enrolling by invitation
The Influence of Hydration on the Viscoelastic Properties of Soft Tissues, Pain and Mobility of Patients
Low Back Pain (LBP), Fascial Manipulation
Recruiting
Dermatological Acceptability and Efficacy in Improving Xerosis, Skin Hydration, and Barrier Function
Xerosis, Dry Skin
Not yet recruiting
Effects of Increased Water Intake on Hormonal Response, Hydration Status, and Physical Function in Low-drinking Older Adults
Dehydrated, Water-Electrolyte Imbalance, Malnutrition, Dehydration (Physiology)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Williams, MPH study chair
Abbott Nutrition
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Rehydration Solution and Water in people with Hydration, run by Abbott Nutrition at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Enrollment Challenges). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anaerobic Power (time frame: Through Study completion, an average of 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.