AbsorptionNCT06524674
Clinical Study to Compare the Effect of an Oral Rehydration Solution on the Rate of Absorption of Functional Ingredients
A study testing Hydration Multiplier + Energy, Hydration Multiplier + Sleep and Energy Comp in people with Absorption and Pharmacokinetic, run by Liquid I.V. at 1 site in United States.
Trial summary
The objective of this study was to compare the individual pharmacokinetics of functional ingredients included in an oral rehydration solution (ORS) with or without the inclusion of active base ingredients (carbohydrate and electrolytes). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Absorption, Pharmacokinetic
- What is being tested?
- Hydration Multiplier + Energy, Hydration Multiplier + Sleep and Energy Comp
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2023to 31 May 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects must be healthy males or females, aged 18 to 55 inclusive at the time of screening, with a body mass index (BMI) of 18.0 to 34.9 kg/m2 (normal weight to Class I Obesity).
- Subjects must be able to understand the study, agree to the requirements and restrictions, and be willing to give voluntary consent to participate in the study.
- Subjects are willing to have up to nine (9) blood collections on a single study day. No clinically significant abnormal findings with the medical / surgical / medication history, abbreviated physical examination (vitals and Anthropometrics), or clinical laboratory investigations (blood tests) in the opinion of the Principal Investigator.
- Female subjects of childbearing potential must agree to one of the following methods of birth control from screening through the duration of the study.
- Acceptable methods include: abstinence, same-sex partner, double barrier (condom, diaphragm, or cervical cap with spermicidal foam, gel, or cream); intra-uterine device (IUD) with or without hormones in place or hormonal contraception (oral, injectable, implantable, transdermal, or vaginal) used consecutively for at least 3 month prior to screening visit; vasectomized partner or bilateral insertion of Essure® implants (or analogous) for at least 6 months prior to the screening visit; to be considered a female of non-childbearing potential, subject must have had a bilateral tubal ligation, hysterectomy or bilateral oophorectomy; or postmenopausal status with amenorrhea (no menstruation) for at least 1 year prior to the screening visit.
- Subject is willing to comply with the study restrictions.
Who cannot join
- Subjects who are participating in another Clinical Trial.
- Subjects who faint during blood collection, or who have a phobia of needles, or a phobia of blood.
- Subjects who have been diagnosed with any sleep disorder.
- Subjects who are night shift workers.
- Subjects who use tobacco or nicotine-containing products or devices within 1 year prior to the screening visit through the end of study.
- Females who are pregnant or lactating (verbal confirmation only).
Show all 26Show fewer
- Subjects with history or presence of any clinically significant cardiovascular, pulmonary, respiratory, hepatic, renal, hematological, gastrointestinal, endocrine (e.g., insulin resistance, diabetes I or II), immunologic (e.g., arthritis), dermatologic, neurological, psychiatric disease or disorder (including anxiety or depression), or any uncontrolled medical illness which in the opinion of the Investigator would jeopardize the safety of the subject, interfere with study assessments, or impact the validity of the study results.
- Subjects with history of any gastrointestinal surgery, gastrointestinal illness which in the opinion of the Investigator would affect the digestive and absorption processes of the body (i.e., Gastric bypass, Gastroenteritis, Irritable Bowel Syndrome, Celiac Disease).
- Subjects with history of cancer (except localized skin cancer without metastases) within 5 years prior to the screening visit. Subjects who exhibit evidence of hepatic or renal dysfunction as evidenced by abnormal ALT, AST or ALP level ≥2 times of the upper limit of normal range or abnormal serum creatinine level ≥ 2.0 mg/dl or other clinically significant laboratory value per Investigator discretion.
- Subjects with positive laboratory result for HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody.
- Subjects with history of substance or alcohol abuse within 1 year prior to the screening visit (whereas had to be seen in an Emergency Room, Urgent Care or was hospitalized for care of such).
- Subjects who received any investigational product within 30 days prior to the screening visit.
- Subjects with recent or current medical condition that may significantly affect the PK analysis, compromise the safety of the subject, or impact the validity of the study results in the opinion of the Investigator.
- Subjects who have a known or suspected allergy or sensitivity to study products or any of its ingredient(s) or to any comparable products in the opinion of the Investigator (e.g., caffeine, vitamin C, L-theanine (including green tea), melatonin etc.)
- Subjects who use any prescription or over-the-counter (OTC) medication, vitamins, herbal products, antacids, mineral supplements and dietary supplements, within 4 weeks prior to the 1st study period and through the end of study (with the exception of acetaminophen).
- Chronic use of NSAIDs (e.g., Ibuprofen, Advil), or use of NSAIDs at one-week prior to each study Visit.
- Subjects being treated with any known enzyme-altering drugs such as barbiturates, glucocorticoids, macrolides, antidepressants, neuroleptics, imidazole's, fluoroquinolones, calcium channel blockers, proton pump inhibitors, or H2-receptor antagonists, etc., within 30 days prior to screening or through the end of study.
- Subjects who (for whatever reason) have been on a self-restricted diet, controlled diet or special therapeutic diet, or who have had substantial changes in eating habits within 30 days prior to PK Test Period 1 or through the end of study.
- Subjects with difficulty fasting or consuming standard meals or snacks.
- Subjects with a proclivity to lose consciousness (faint / pass-out), feel weak, feel dizzy, or feel nauseous.
- Donation of blood (>300 ml) within 30 days or plasma within 7 days prior to PK Test Period 1 or through the end of study. Intolerance to venipuncture and intravenous cannulation.
- Subjects who are currently taking biotin supplements or have stopped taking Biotin within the last month to pre-study screening.
- Subjects who are currently taking or have taken within the last month before pre-study screening any form of psychoactive, or psychotropic drugs, including cannabinoids, CBD oils or THC.
- Subjects who are transgender or receiving any form of therapeutic intervention to instigate or maintain gender changes, or performance enhancing drugs, e.g., hormonal injections, steroid injections.
- Subjects who have taken L-theanine, melatonin, valerian root, GABA, tart cherry, amla, ashwagandha, rhodolia, ginseng, shatavari less than 14 days of pre-screening visit.
- Subjects whose veins have been deemed unsuitable for the study during screening checks.
Trial locations and contacts
1 site in 1 country.
United States1 site
Princeton Consumer Research
Raritan, New Jersey, 08869
About this study
Official title: A Single-Blind, Controlled, Cross-Over Clinical Study to Compare the Effect of an Oral Rehydration Solution on the Rate of Absorption of Functional Ingredients
The objective of this study was to compare the individual pharmacokinetics of functional ingredients included in an oral rehydration solution (ORS) with or without the inclusion of active base ingredients (carbohydrate and electrolytes). The functional ingredients included in both the control and test solutions were Melatonin in conjunction with L-theanine (Arm 1), Caffeine in conjunction with L-theanine (Arm 2), and Vitamin C in conjunction with Zinc (Arm 3), across two study periods.
The primary outcomes of this study included the relative pharmacokinetics of each functional ingredient. These included: maximum observed concentration (C max), time of maximum observed concentration (T max), cumulative Area Under the Curve (AUC) for each timepoint, (including AUC from the time of dosing to the time of last observation) and the concentration at each timepoint for the corresponding functional ingredients included in the specific study arm (i.e., melatonin, L-theanine, caffeine, vitamin C and zinc).
- Conditions
- Absorption, Pharmacokinetic
- Being tested
- Hydration Multiplier + Energy, Hydration Multiplier + Sleep, Energy Comp, Sleep Comp
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydration Multiplier + EnergyDietary supplement
Participants will be administered one oral serving of an oral rehydration solution containing caffeine and l-theanine
Hydration Multiplier + SleepDietary supplement
Participants will be administered one oral serving of an oral rehydration solution containing melatonin and l-theanine
Energy CompDietary supplement
Participants will be administered one oral serving of a comparator oral rehydration solution containing caffeine and l-theanine
Sleep CompOther
Participants will be administered one oral serving of a comparator oral rehydration solution containing melatonin and l-theanine
| Study group | Role | What they receive |
|---|---|---|
| Sleep | Active comparator | Participants self-administered one serving of an oral rehydration solution followed by subsequent blood draws Receives: Dietary Supplement: Hydration Multiplier + Sleep |
| Energy | Active comparator | Participants self-administered one serving of an oral rehydration solution followed by subsequent blood draws Receives: Dietary Supplement: Hydration Multiplier + Energy |
| Sleep Comp | Placebo comparator | Participants self-administered one serving of an oral rehydration solution followed by subsequent blood draws Receives: Other: Sleep Comp |
| Energy Comp | Placebo comparator | Participants self-administered one serving of an oral rehydration solution followed by subsequent blood draws Receives: Dietary Supplement: Energy Comp |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative pharmacokinetics
The primary outcomes of this study included the relative pharmacokinetics of each functional ingredient. This included maximum observed concentration (C max) for the corresponding functional ingredients included in the specific study arm (i.e., melatonin, L-theanine, caffeine, vitamin and zinc).
Measured: 6 weeks
Relative pharmacokinetics
The primary outcomes of this study included the relative pharmacokinetics of each functional ingredient. This included time of maximum observed concentration (T max) for the corresponding functional ingredients included in the specific study arm (i.e., melatonin, L-theanine, caffeine, vitamin C and zinc).
Measured: 6 weeks
Relative pharmacokinetics
The primary outcomes of this study included the relative pharmacokinetics of each functional ingredient. This included: cumulative Area Under the Curve (AUC) for each timepoint, (including AUC from the time of dosing to the time of last observation) and the concentration at each timepoint for the corresponding functional ingredients included in the specific study arm (i.e., melatonin, L-theanine, caffeine, vitamin C and zinc).
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start1 Oct 2023
- Primary completion31 Jan 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AbsorptionStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liquid I.V.
- Sponsor type
- University, hospital or other
- Collaborators
- Princeton Consumer Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06524674
- Sponsor's protocol ID
- PKPD
- Status last verified
- Jul 2024
- First submitted
- 11 Jun 2024
- 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
- A Single-Blind, Controlled, Cross-Over Clinical Study to Compare the Effect of an Oral Rehydration Solution on the Rate of Absorption of Functional Ingredients
- ClinicalTrials.gov ID
- NCT06524674
- Acronym / sponsor ID
- PKPD
- Conditions
- Absorption, Pharmacokinetic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Liquid I.V.University, hospital or other
- Collaborators
- Princeton Consumer Research
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 29 Jul 2024 (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.
The objective of this study was to compare the individual pharmacokinetics of functional ingredients included in an oral rehydration solution (ORS) with or without the inclusion of active base ingredients (carbohydrate and electrolytes). The functional ingredients included in both the control and test solutions were Melatonin in conjunction with L-theanine (Arm 1), Caffeine in conjunction with L-theanine (Arm 2), and Vitamin C in conjunction with Zinc (Arm 3), across two study periods.
The primary outcomes of this study included the relative pharmacokinetics of each functional ingredient. These included: maximum observed concentration (C max), time of maximum observed concentration (T max), cumulative Area Under the Curve (AUC) for each timepoint, (including AUC from the time of dosing to the time of last observation) and the concentration at each timepoint for the corresponding functional ingredients included in the specific study arm (i.e., melatonin, L-theanine, caffeine, vitamin C and zinc).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sleep | Active comparator | Dietary Supplement: Hydration Multiplier + SleepParticipants self-administered one serving of an oral rehydration solution followed by subsequent blood draws |
| Energy | Active comparator | Dietary Supplement: Hydration Multiplier + EnergyParticipants self-administered one serving of an oral rehydration solution followed by subsequent blood draws |
| Sleep Comp | Placebo comparator | Other: Sleep CompParticipants self-administered one serving of an oral rehydration solution followed by subsequent blood draws |
| Energy Comp | Placebo comparator | Dietary Supplement: Energy CompParticipants self-administered one serving of an oral rehydration solution followed by subsequent blood draws |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Subjects must be healthy males or females, aged 18 to 55 inclusive at the time of screening, with a body mass index (BMI) of 18.0 to 34.9 kg/m2 (normal weight to Class I Obesity).
- Subjects must be able to understand the study, agree to the requirements and restrictions, and be willing to give voluntary consent to participate in the study.
- Subjects are willing to have up to nine (9) blood collections on a single study day. No clinically significant abnormal findings with the medical / surgical / medication history, abbreviated physical examination (vitals and Anthropometrics), or clinical laboratory investigations (blood tests) in the opinion of the Principal Investigator.
- Female subjects of childbearing potential must agree to one of the following methods of birth control from screening through the duration of the study.
- Acceptable methods include: abstinence, same-sex partner, double barrier (condom, diaphragm, or cervical cap with spermicidal foam, gel, or cream); intra-uterine device (IUD) with or without hormones in place or hormonal contraception (oral, injectable, implantable, transdermal, or vaginal) used consecutively for at least 3 month prior to screening visit; vasectomized partner or bilateral insertion of Essure® implants (or analogous) for at least 6 months prior to the screening visit; to be considered a female of non-childbearing potential, subject must have had a bilateral tubal ligation, hysterectomy or bilateral oophorectomy; or postmenopausal status with amenorrhea (no menstruation) for at least 1 year prior to the screening visit.
Key exclusion criteria (26 listed)
- Subjects who are participating in another Clinical Trial.
- Subjects who faint during blood collection, or who have a phobia of needles, or a phobia of blood.
- Subjects who have been diagnosed with any sleep disorder.
- Subjects who are night shift workers.
- Subjects who use tobacco or nicotine-containing products or devices within 1 year prior to the screening visit through the end of study.
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 |
|---|---|---|
| Hydration Multiplier + EnergyParticipants will be administered one oral serving of an oral rehydration solution containing caffeine and l-theanine | Dietary supplement | Energy |
| Hydration Multiplier + SleepParticipants will be administered one oral serving of an oral rehydration solution containing melatonin and l-theanine | Dietary supplement | Sleep |
| Energy CompParticipants will be administered one oral serving of a comparator oral rehydration solution containing caffeine and l-theanine | Dietary supplement | Energy Comp |
| Sleep CompParticipants will be administered one oral serving of a comparator oral rehydration solution containing melatonin and l-theanine | Other | Sleep Comp |
Primary outcome
Relative pharmacokinetics
Time frame: 6 weeks
The primary outcomes of this study included the relative pharmacokinetics of each functional ingredient. This included maximum observed concentration (C max) for the corresponding functional ingredients included in the specific study arm (i.e., melatonin, L-theanine, caffeine, vitamin and zinc).
Relative pharmacokinetics
Time frame: 6 weeks
The primary outcomes of this study included the relative pharmacokinetics of each functional ingredient. This included time of maximum observed concentration (T max) for the corresponding functional ingredients included in the specific study arm (i.e., melatonin, L-theanine, caffeine, vitamin C and zinc).
Relative pharmacokinetics
Time frame: 6 weeks
The primary outcomes of this study included the relative pharmacokinetics of each functional ingredient. This included: cumulative Area Under the Curve (AUC) for each timepoint, (including AUC from the time of dosing to the time of last observation) and the concentration at each timepoint for the corresponding functional ingredients included in the specific study arm (i.e., melatonin, L-theanine, caffeine, vitamin C and zinc).
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydration Multiplier + Energy, Hydration Multiplier + Sleep and Energy Comp in people with Absorption and Pharmacokinetic, 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 6 inclusion and 26 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?
Relative pharmacokinetics (time frame: 6 weeks). The study lists 3 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.