Clinical Study to Compare the Effect of an Oral Rehydration Solution on the Rate of Absorption of Functional Ingredients

NCT06524674 | Completed

• 1 other identifier: PKPD
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief 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). 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

Outcome Measures

Primary Outcomes (3)

• 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).

  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).

  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).

  6 weeks

Study Arms (4)

Sleep

ACTIVE COMPARATOR

Participants self-administered one serving of an oral rehydration solution followed by subsequent blood draws

Dietary Supplement: Hydration Multiplier + Sleep

Energy

ACTIVE COMPARATOR

Participants self-administered one serving of an oral rehydration solution followed by subsequent blood draws

Dietary Supplement: Hydration Multiplier + Energy

Sleep Comp

PLACEBO COMPARATOR

Participants self-administered one serving of an oral rehydration solution followed by subsequent blood draws

Other: Sleep Comp

Energy Comp

PLACEBO COMPARATOR

Participants self-administered one serving of an oral rehydration solution followed by subsequent blood draws

Dietary Supplement: Energy Comp

Interventions

Hydration Multiplier + Energy DIETARY_SUPPLEMENT

Participants will be administered one oral serving of an oral rehydration solution containing caffeine and l-theanine

Energy

Hydration Multiplier + Sleep DIETARY_SUPPLEMENT

Participants will be administered one oral serving of an oral rehydration solution containing melatonin and l-theanine

Sleep

Energy Comp DIETARY_SUPPLEMENT

Participants will be administered one oral serving of a comparator oral rehydration solution containing caffeine and l-theanine

Energy Comp

Sleep Comp OTHER

Participants will be administered one oral serving of a comparator oral rehydration solution containing melatonin and l-theanine

Sleep Comp

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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).

Sponsors & Collaborators

• Liquid I.V.: lead
• Princeton Consumer Research: collaborator

Study Sites (1)

Princeton Consumer Research

Raritan, New Jersey, 08869, United States

Location

MeSH Terms

Interventions

Sleep

Intervention Hierarchy (Ancestors)

Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: July 29, 2024
• Study Start: October 1, 2023
• Primary Completion: January 31, 2024
• Study Completion: May 31, 2024
• Last Updated: July 29, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)