The Effect of AMP Human Sodium Bicarbonate Lotion on Hydration
Condition: Fluid Retention; Fluid Loss; Sodium Retention; Cognitive Change; Heat Exposure; Hyperhydration; Electrolyte and Fluid Balance Conditions
MeSH terms: Hypernatremia; Water Intoxication
Study type: Interventional

Summary: 
      The purpose of this research study is to evaluate the effects of a topical sodium bicarbonate
      lotion on physiological and psychological responses associated with hydration status and
      fluid balance in humans during passive heat stress. Currently, the ingestion of sodium has
      been an effective measure for improvements in fluid regulation and hydration status in
      humans. However, the investigators do not know its regulatory relationship with measurements
      of fluid balance when supplemented through the skin.
    

Detailed description: 
      Design This laboratory study is a randomized, counterbalanced, crossover design involving 20
      participants (20 males) from the local community and university. This project will be
      conducted within the thermal physiology laboratory, complete with a climatic chamber
      (Cantrol, CES +13/+44) located within the Human Performance Laboratory (HPL) at the
      University of Connecticut. The investigators expect each interested individual will complete
      both phases included within the study design within a randomized, counterbalanced order.

      Participant grouping orders will be randomly assigned by the project's lead student
      investigator (Jeb Struder). Each phase will be fairly similar in procedures completed;
      however, one phase will be completed with a trial that introduces a biomedical intervention
      (sodium bicarbonate topical lotion; PR group), while the other phase will be completed with a
      trial that introduces a placebo (PLA group) product similar to the biomedical intervention.
      Approximately 24 hours should pass between the completion of each session within a phase of
      the study. Additionally, approximately 3 days should pass between the completion of a phase
      and the initiation of the next phase (5th session completed).

      Environmental Conditions Sessions I, II, and III of both counterbalanced groups (PR and PLA)
      will all be completed within thermoneutral conditions. Session IV of both counterbalanced
      groups (PR and PLA) will be conducted within the climatic chamber set to a climate with
      ambient temperature at approximately 33C (91.4F) and relative humidity at approximately 25%.

      Baseline Assessments (PR/PLAI, PR/PLAII, PR/PLA III) Baseline visits should be completed over
      3 consecutive days for the establishment of baseline measurements regarding the participant's
      body weight, dietary behaviors, and hydration status. Each assessment will be performed at
      the relatively same time of day (early to late morning) and will involve approximately 30
      minutes spent within the laboratory space of the Human Performance Laboratory (HPL). All
      Baseline Assessment sessions will consist of fairly similar data collection procedures and
      will begin with the participant providing the completed 24-h dietary recall log, thirst
      perception scale, and filled urine jug to the administrating researcher. Additionally, the
      participant will be asked to provide a morning urine sample and nude body weight for the
      assessment of session-specific hydration status and Fluid Retention Index (FRI). Furthermore,
      once these tasks are completed, an HPL trained researcher will conduct a blood draw for the
      collection of approximately ½ teaspoon of blood. Each session will deviate slightly in
      additional tasks required for completion.

      Day 1 (PR/PLAI): After the collection of a morning urine sample and nude body weight
      measurement, the participant's height (for additional anthropometrics) and resting blood
      pressure (for safety precautions) will be measured. Additionally, after the completion of the
      blood draw, the final task for this session will be the participant's familiarization to the
      Cognitive/Perceptual Battery tasks that you will be tested during Session 4 (PR/PLAIV).

      Day 2 (PR/PLAII): After the collection of a morning urine sample and nude body weight
      measurement, the participant will be asked to rest within a comfortable position for
      approximately 10-15 minutes for the measurement of their resting heart rate.

      Day 3 (PR/PLAIII): After the collection of a morning urine sample and nude body weight
      measurement, the participant will have their body fat percentage measured via handheld Lange
      Skinfold Calipers.

      Intervention Trial (PR/PLAIV) Pre-Testing Procedures Prior to completing all Intervention
      Trial visits, participants will be asked to drink 500 mL of water before going to bed and an
      additional 500 mL of water upon waking to ensure proper hydration. If morning sample urine
      USG is ≤1.020, participants will be cleared to participate. If the participant arrives with a
      urine USG between 1.020 and 1.025, the subject will be asked to drink an additional 500 mL of
      water prior to entering the chamber to ensure proper hydration status. If participants arrive
      at the lab with a urine USG >1.025, the visit will be rescheduled for the following day. In
      addition to completing a morning urine spot sample, participants will be asked to complete a
      nude body mass measurement as well as provide their completed thirst perception scale,
      dietary recall log, and urine jug. Furthermore, using the urine and nude body weight
      measurements collected, the session-specific FRI will be assessed. Afterwards, the
      participant will be provided a standardized breakfast. Once the participant has indicated
      they are finished with their meal, resting blood pressure measurements will be conducted.
      Once all measurements have been completed, participants will have a venous cannula inserted
      by an HPL trained research team member. Finally, prior to entering the environmental chamber,
      participants will be instructed to privately insert the rectal thermometer 10-15 cm beyond
      the anal sphincter in addition to completing an additional nude body mass measurement and
      being fitted with a heart rate strap by the administrating research team.

      Data Collection - Initial 120-minutes Upon the completion of participant arrival procedures,
      participants will then be permitted to enter the environmental chamber (~33C [91.4F], ~25%
      relative humidity) where they will be instructed to sit down and begin a 30-minute period of
      environmental equilibration. Once this period has been initiated the participant will be
      asked to complete their baseline measurements in regard to the Cognitive/Perceptual Battery.
      After the equilibration period has been completed, the participant will have their resting
      blood pressure measured, provide a baseline blood sample (~11 mL), and then provide both a
      urine sample and nude body weight measurement. Once all of these tasks have been completed,
      the participant will be provided approximately 50 g of the topical lotion (i.e. PR Lotion or
      Placebo) to apply to their upper body. Afterwards, blood samples (~3 mL) will be collected
      approximately 15- and 30-minutes post-lotion application. Furthermore, the hyperhydration
      protocol will be initiated at the 30-minute post-lotion application time point. During this
      time period, the first of 4 fluid boluses will be provided to the participant for consumption
      with instructions to consume all fluids provided within the allotted 15-minute time period
      before the provision of their next fluid bolus. Additionally, before the 3rd fluid bolus has
      been provided for consumption (identified as time point -30 min in Figure 4), another blood
      sample (~11 mL) will be completed before completing the rest of the hyperhydration protocol.

      Hyperhydration Protocol To induce hyperhydration, participants will drink a total fluid
      volume of approximately 25 mL/kg of fat free mass (FFM) of water. These solutions will be
      pre-measured and provided within four enclosed water bottles for consumption at a rate of
      approximately 6.5 mL/kg FFM about every 15 minutes within a duration of approximately 60
      minutes.

      Topical Solution Procedures Approximately 50 grams of the topical solution will be
      pre-measured into 2 separate plastic bags and provided to the participant for application.
      Participants will be instructed to apply the solution primarily to areas of their upper
      extremities which will include an identified area from the wrist up to the clavicular area of
      the shoulder in addition to their chest, neck, upper back, midsection, and lower back if
      enough solution is available. Application will be considered complete when the solution has
      been transmitted to the skin in a fashion to where no residue from the lotion is visible by
      researchers from the skin of the participant.

      Data Collection - 3-hour Protocol Collection of Blood Samples Aside from the baseline blood
      sample collected around the -90-minute time point, an initial blood sample will occur at time
      point 0 min, where approximately 11 mL of blood will be collected via the inserted cannula.
      Similar blood samples will be collected at time intervals of approximately 60-minutes up to
      the completion of the data collection protocol, occurring around the 180-minute mark
      (approximately 3-hours). In total, approximately 72 mL of blood will be collected during the
      Intervention Trial, which is less than ¼ of the amount of blood collected during a blood
      donation.

      Collection of Urine Samples and Body Weight Measurements For the collection of all urine spot
      samples, researchers will provide a clean cup and top to seal the capsule. Participants will
      be asked to provide a sample regardless of urgency to urinate at specific time points during
      the trial. If the participant is unable to provide a sample at the time point requested, no
      protocol deviation will be considered as the lack in sample provided will still be used
      towards the completion of data analysis. Furthermore, if the participant must provide a urine
      sample without being requested by a research team member, any urine expelled will be added to
      the amount collected (if any) during the next urine sample collection time point.
      Additionally, participants will be instructed to complete a measurement of nude body weight
      completed before the provision of a urine sample. Both the collection of urine samples and
      measurement of body weight will be completed within the privacy of a bathroom. Aside from the
      baseline measurement completed around the -90-minute time point, the initial urine sample
      collection and body weight measurement for the intervention (i.e. PR Lotion or Placebo) will
      approximately occur at time point 0-minutes and supplementary urine collection and body
      weight measurement will be completed in 30-minute intervals up to the end of the data
      collection period, occurring around the 180-minute mark (approximately 3-hours).

      Completion of Cognitive/Perceptual Battery Aside from the baseline Cognitive/Perceptual
      Battery completed around the -115-minute time point, the initial Cognitive/Perceptual Battery
      will be completed at time point 0-minutes. Completion of supplemental Cognitive/Perceptual
      Batteries will be continually measured within a 60-minute time interval from time point
      0-minutes until the completion of data collection which will coincide with the 180-minute
      time point (approximately 3-hours).
    

Intervention name(s): PR Lotion - AMP Human Performance; Placebo Lotion
Intervention type(s): Other; Other
Intervention description(s): Sodium Bicarbonate Topical Solution. For use of the PR Lotion solution, consumers are instructed to apply the lotion to areas of the body that have been identified as most likely to use during their activity (i.e. calves and thighs for runners, shoulders and forearms for swimmers, etc.). Moreover, the product can be applied up to 2 hours prior to beginning a workout or event with one use supporting a 4-6 hour workout. AMP Human has also verified the safety of their product as being well tolerated in consumers >2 years of age unless there is a known allergy to an ingredient on the label. Moreover, to the company's knowledge no side effects have been reported per the SAFETY Section at https://amphuman.com/pages/faq.; Placebo Topical Solution. Lotion will be created by the AMP Human Performance company and will include all ingredients similar to the PR Lotion product except for the exclusion of sodium bicarbonate.
Other intervention name(s): NDC Code: 72358-101-01; NDC Code: 72358-101-02; NDC Code: 72358-101-03
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Sodium Bicarbonate; Topical Lotion