A Clinical Trial to Explore the Efficacy of Two Investigational Products on Post-Exercise Hydration in Recreationally Active Healthy Adults

Официальное название

A Randomized, Triple-Blind, Comparator-Controlled, Cross-Over Clinical Trial to Explore the Efficacy of Two Investigational Products on Post-Exercise Hydration in Recreationally Active Healthy Adults

Обзор

The goal of this clinical trial is to explore the efficacy of two investigational products for promoting post-exercise hydration in recreationally active healthy adults. The main question it aims to answer is: Does consumption of each investigational product (IP) beverage, compared to control beverages, result in differences in blood hematocrit and serum osmolality at 0.5, 2, 4, and 8 hours post-exercise in recreationally active healthy adults? Researchers will compare two IPs to control beverages to see if the IPs are effective for supporting post-exercise hydration. Participants will be required to consume the IPs, as well as control beverages. Participants will also complete questionnaires, undergo an exercise challenge, and record their food and beverage intake.

Вмешательства

• Пищевая добавка Potassium15
  Immediately after exercise, participants will consume one bottle (591 mL) of the study product within 10 minutes and in the presence of clinic staff.
• Пищевая добавка Potassium10
  Immediately after exercise, participants will consume one bottle (591 mL) of the study product within 10 minutes and in the presence of clinic staff.
• Другое Plain Water
  Immediately after exercise, participants will consume one bottle (591 mL) of the study product within 10 minutes and in the presence of clinic staff.
• Другое Gatorade Fruit Punch
  Immediately after exercise, participants will consume one bottle (591 mL) of the study product within 10 minutes and in the presence of clinic staff.

Первичные конечные точки

• Change in Blood Hematocrit [Срок оценки: 0.5-, 2-, 4-, and 8-hours post-exercise from visit 2 to visit 5]
• Change in Serum Osmolality [Срок оценки: 0.5-, 2-, 4-, and 8-hours post-exercise from visit 2 to visit 5]

Вторичные конечные точки (11)

• Change in Mean Corpuscular Volume [Срок оценки: 0.5-, 2-, 4-, and 8-hours post-exercise from visit 2 to visit 5]
• Change in Sodium [Срок оценки: 0.5-, 2-, 4-, and 8-hours post-exercise from visit 2 to visit 5]
• Change in Potassium [Срок оценки: 0.5-, 2-, 4-, and 8-hours post-exercise from visit 2 to visit 5]
• Change in Blood Urea Nitrogen [Срок оценки: 0.5-, 2-, 4-, and 8-hours post-exercise from visit 2 to visit 5]
• Change in Urine Volume [Срок оценки: 0.5-, 2-, 4-, and 8-hours post-exercise from visit 2 to visit 5]
• Change in Urine Specific Gravity [Срок оценки: 0.5-, 2-, 4-, and 8-hours post-exercise from visit 2 to visit 5]
• Change in Urine Osmolality [Срок оценки: 0.5-, 2-, 4-, and 8-hours post-exercise from visit 2 to visit 5]
• Change in Body Weight [Срок оценки: 0.5-, 2-, 4-, and 8-hours post-exercise from visit 2 to visit 5]
• Change in intracellular water [Срок оценки: 0.5-, 2-, 4-, and 8-hours post-exercise from visit 2 to visit 5]
• Change in extracellular water [Срок оценки: 0.5-, 2-, 4-, and 8-hours post-exercise from visit 2 to visit 5]
• Change in total body water [Срок оценки: 0.5-, 2-, 4-, and 8-hours post-exercise from visit 2 to visit 5]

Критерии участия

Критерии включения

• Males and females between 18 and 65 years of age
• Females not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening Or,

Individuals of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:

• Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
• Double-barrier method
• Intrauterine devices
• Non-heterosexual lifestyle and agrees to use contraception if planning on changing to heterosexual partner(s)
• Vasectomy of partner at least 6 months prior to screening
• Abstinence and agrees to use contraception if planning on becoming sexually active during the study
• Physically fit for exercise, as assessed by the Physical Activity Readiness Questionnaire (PAR-Q), and is willing and able to complete the exercise challenge throughout the study
• Self-reported hard or very hard aerobic exercise of ≥30 and ≤150 minutes per week, as assessed by the Stanford 7-Day Physical Activity Recall at screening
• Agrees to maintain usual physical activity level for the duration of the study and not to engage in vigorous physical activity for at least 24 hours prior to each clinic visit
• Agrees to abstain from alcohol consumption for at least 48 hours prior to each clinic visit and caffeine consumption and physical exercise on the morning of each study visit
• Agrees to adhere to the dietary guidelines for the duration of the study, inclusive of the run-in period
• Agrees to maintain current lifestyle habits (diet, medications, supplements, and sleep) as much as possible throughout the study
• Willingness to complete questionnaires, records, and diaries associated with the study and to complete all clinic visits
• Provided voluntary, written, informed consent to participate in the study
• Healthy as determined by medical history as assessed by the Qualified Investigator (QI)

Критерии исключения

• Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
• Allergy, sensitivity, intolerance, or dietary restriction, including dairy sensitivity/intolerance, preventing consumption of investigational product, comparator/control ingredients, or standardized meal
• Self-reported unstable weight for the past 3 months defined as having gained or lost more than 5% of body weight prior to baseline
• Poor venous access as assessed by the QI
• Unstable metabolic disease or chronic diseases as assessed by the QI
• Current or history of any significant diseases of the gastrointestinal tract as assessed by the QI
• Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the QI (See Section 7.3)
• Type I or Type II diabetes and diabetes insipidus
• Significant cardiovascular event in the past 6 months. Participants with no significant cardiovascular event on stable medication may be included after assessment by the QI on a case-by-case basis
• History of or current diagnosis with kidney and/or liver diseases as assessed by the QI on a case-by-case basis, with the exception of history of kidney stones in participants who are symptom free for 6 months
• Self-reported confirmation of current or pre-existing thyroid condition. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
• Major surgery in the past 3 months or individuals who have planned surgery during the course of the study. Participants with minor surgery will be considered on a case-by-case basis by the QI
• Cancer, except skin basal cell carcinoma completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable
• Individuals with an autoimmune disease or are immune compromised as assessed by the QI
• Self-reported confirmation of a HIV-, Hepatitis B- and/or C-positive diagnosis as assessed by the QI
• Self-reported confirmation of blood/bleeding disorders as assessed by the QI
• Use of prescribed medical cannabinoid products
• Chronic use of THC products (>2 times/week). Occasional users will be required to washout (3-day washout period) and abstain for the duration of the study period
• Regular use of tobacco or nicotine products in the past six months, as assessed by the QI. Occasional users will be required to washout and abstain for the duration of the study period
• Alcohol intake average of >2 standard drinks per day as assessed by the QI
• Alcohol or drug abuse within the last 12 months
• Current use of prescribed and/or over-the-counter (OTC) medications, supplements, and/or consumption of food/drinks that may impact the efficacy of the investigational product by altering body water regulation (Sections 7.3.1 and 7.3.2)
• Blood donation 60 days prior to baseline, during the study, or a planned donation within 30 days of the last study visit
• Participation in other clinical research studies 30 days prior to baseline, as assessed by the QI
• Individuals who are cognitively impaired and/or who are unable to give informed consent
• Any other condition or lifestyle factor, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• KGK Science Inc. — London

Идентификаторы

NCT: NCT07564661 · 25CHKGC01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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