ToleranceNCT05428748
Clinical Trial to Evaluate Safety and Tolerability of a Novel Hydration Drink in Healthy Volunteers
A study testing 1 serving of test product, 2 servings of test product and 3 servings of test product in people with Tolerance, run by Liquid I.V. at 1 site in United States.
Trial summary
This clinical trial design aims to evaluate the safety and tolerability of a novel hydration drink in health volunteers. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Tolerance
- What is being tested?
- 1 serving of test product, 2 servings of test product and 3 servings of test product
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2022to 1 Mar 2023
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy individuals who are between 18 - 35 years of age. Have a body mass index (BMI) range of 18.0 - 24.9 kg/m2. Willing and able to agree to the requirements and restrictions of this study, be willing to give voluntary consent, be able to understand and read the questionnaires, and carry out all study-related procedures
Who cannot join
- Participant has a positive medical history of heart disease/cardiovascular disease, uncontrolled hypertension (140/90 or greater mmHg), kidney disease (dialysis or renal failure), hepatic impairment or disease, or Type I or Type II diabetes. Participant has a positive medical history of unstable thyroid disease, previously diagnosed major affective disorder, psychiatric disorder that required hospitalization in the prior year, immune disorder (i.e., HIV/AIDS), a history of cancer (except localized skin cancer without metastases or in situ cervical cancer within 5 years prior to screening visit. Participant has an abnormality or obstruction of the gastrointestinal tract precluding swallowing (e.g. dysphagia) and digestion (e.g., known intestinal malabsorption, celiac disease, inflammatory bowel disease, chronic pancreatitis, steatorrhea). Individuals who are lactating, pregnant or planning to become pregnant during the study. Have a known sensitivity or allergy to any of the study products. Any condition or abnormality that, in the opinion of the investigator, would compromise the safety of the participant or the quality of the study data. History of alcohol or substance abuse in the 12 months prior to screening. Receipt or use of an investigational product in another research study within 28 days prior to baseline/Visit 2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Parallel and Randomized Trial to Assess the Safety and Tolerability of a Novel Hydration Drink in Healthy Volunteers
This clinical trial design aims to evaluate the safety and tolerability of a novel hydration drink in health volunteers.
- Conditions
- Tolerance
- Being tested
- 1 serving of test product, 2 servings of test product, 3 servings of test product, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1 serving of test productOther
Participants will consume 1 serving/day of the test product for 28 days
2 servings of test productOther
Participants will consume 2 servings/day of the test product for 28 days
3 servings of test productOther
Participants will consume 3 servings/day of the test product for 28 days
PlaceboOther
Participants will consume 1 serving/day of the placebo for 28 days
| Study group | Role | What they receive |
|---|---|---|
| 1S | Experimental | Participants will consume 1 serving/day of the test product for 28 days. Receives: Other: 1 serving of test product |
| 2S | Experimental | Participants will consume 2 servings/day of the test product for 28 days Receives: Other: 2 servings of test product |
| 3S | Experimental | Participants will consume 3 servings/day of the test product for 28 days Receives: Other: 3 servings of test product |
| Placebo | Placebo comparator | Participants will consume 1 serving/day of the placebo for 28 days Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of test product
To assess the safety of the test product (TP) via comprehensive metabolic panel, complete blood count, urinalysis, vitals, and observed or reported adverse events.
Measured: 28 days
Tolerability of test product
To assess the tolerability of the test product via participant tolerability questionnaire.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2022
- Study start1 Sep 2022
- Primary completion1 Feb 2023
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ToleranceStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liquid I.V.
- Sponsor type
- University, hospital or other
- Collaborators
- University of Memphis
- Responsible party
- Sponsor
- Investigators
- Richard Bloomer, PhD, Principal investigator, University of Memphis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05428748
- Sponsor's protocol ID
- SOW5
- Status last verified
- Jul 2024
- First submitted
- 15 Jun 2022
- Last updated
- 29 Jul 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 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Parallel and Randomized Trial to Assess the Safety and Tolerability of a Novel Hydration Drink in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05428748
- Acronym / sponsor ID
- SOW5
- Conditions
- Tolerance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Liquid I.V.University, hospital or other
- Collaborators
- University of Memphis
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 23 Jun 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 clinical trial design aims to evaluate the safety and tolerability of a novel hydration drink in health volunteers.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1S | Experimental | Other: 1 serving of test productParticipants will consume 1 serving/day of the test product for 28 days. |
| 2S | Experimental | Other: 2 servings of test productParticipants will consume 2 servings/day of the test product for 28 days |
| 3S | Experimental | Other: 3 servings of test productParticipants will consume 3 servings/day of the test product for 28 days |
| Placebo | Placebo comparator | Other: PlaceboParticipants will consume 1 serving/day of the placebo for 28 days |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy individuals who are between 18 - 35 years of age. Have a body mass index (BMI) range of 18.0 - 24.9 kg/m2. Willing and able to agree to the requirements and restrictions of this study, be willing to give voluntary consent, be able to understand and read the questionnaires, and carry out all study-related procedures
Key exclusion criteria (1 listed)
- Participant has a positive medical history of heart disease/cardiovascular disease, uncontrolled hypertension (140/90 or greater mmHg), kidney disease (dialysis or renal failure), hepatic impairment or disease, or Type I or Type II diabetes. Participant has a positive medical history of unstable thyroid disease, previously diagnosed major affective disorder, psychiatric disorder that required hospitalization in the prior year, immune disorder (i.e., HIV/AIDS), a history of cancer (except localized skin cancer without metastases or in situ cervical cancer within 5 years prior to screening visit. Participant has an abnormality or obstruction of the gastrointestinal tract precluding swallowing (e.g. dysphagia) and digestion (e.g., known intestinal malabsorption, celiac disease, inflammatory bowel disease, chronic pancreatitis, steatorrhea). Individuals who are lactating, pregnant or planning to become pregnant during the study. Have a known sensitivity or allergy to any of the study products. Any condition or abnormality that, in the opinion of the investigator, would compromise the safety of the participant or the quality of the study data. History of alcohol or substance abuse in the 12 months prior to screening. Receipt or use of an investigational product in another research study within 28 days prior to baseline/Visit 2
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 |
|---|---|---|
| 1 serving of test productParticipants will consume 1 serving/day of the test product for 28 days | Other | 1S |
| 2 servings of test productParticipants will consume 2 servings/day of the test product for 28 days | Other | 2S |
| 3 servings of test productParticipants will consume 3 servings/day of the test product for 28 days | Other | 3S |
| PlaceboParticipants will consume 1 serving/day of the placebo for 28 days | Other | Placebo |
Primary outcome
Safety of test product
Time frame: 28 days
To assess the safety of the test product (TP) via comprehensive metabolic panel, complete blood count, urinalysis, vitals, and observed or reported adverse events.
Tolerability of test product
Time frame: 28 days
To assess the tolerability of the test product via participant tolerability questionnaire.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
- Individual participant dataSharing planned: No
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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.
Richard Bloomer, PhD principal investigator
University of Memphis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1 serving of test product, 2 servings of test product and 3 servings of test product in people with Tolerance, run by Liquid I.V. 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 29 Jul 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety of test product (time frame: 28 days). The study lists 2 primary outcomes in all. 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 29 Jul 2024.