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Clinical Trial to Evaluate Safety and Tolerability of a Novel Hydration Drink in Healthy Volunteers

NCT ID: NCT05428748

Last Updated: 2024-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2023-03-01

Brief Summary

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This clinical trial design aims to evaluate the safety and tolerability of a novel hydration drink in health volunteers.

Detailed Description

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Conditions

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Tolerance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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1S

Participants will consume 1 serving/day of the test product for 28 days.

Group Type EXPERIMENTAL

1 serving of test product

Intervention Type OTHER

Participants will consume 1 serving/day of the test product for 28 days

2S

Participants will consume 2 servings/day of the test product for 28 days

Group Type EXPERIMENTAL

2 servings of test product

Intervention Type OTHER

Participants will consume 2 servings/day of the test product for 28 days

3S

Participants will consume 3 servings/day of the test product for 28 days

Group Type EXPERIMENTAL

3 servings of test product

Intervention Type OTHER

Participants will consume 3 servings/day of the test product for 28 days

Placebo

Participants will consume 1 serving/day of the placebo for 28 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Participants will consume 1 serving/day of the placebo for 28 days

Interventions

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1 serving of test product

Participants will consume 1 serving/day of the test product for 28 days

Intervention Type OTHER

2 servings of test product

Participants will consume 2 servings/day of the test product for 28 days

Intervention Type OTHER

3 servings of test product

Participants will consume 3 servings/day of the test product for 28 days

Intervention Type OTHER

Placebo

Participants will consume 1 serving/day of the placebo for 28 days

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Memphis

OTHER

Sponsor Role collaborator

Liquid I.V.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Richard Bloomer, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Memphis

Locations

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The University of Memphis

Memphis, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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SOW5

Identifier Type: -

Identifier Source: org_study_id