Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04764565 |
| Other study ID # |
PRO-FY2021-96 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 23, 2021 |
| Est. completion date |
April 6, 2021 |
Study information
| Verified date |
April 2021 |
| Source |
University of Memphis |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
While Nuun Instant is commercially available and has received positive reviews from athletes,
there have been no studies to date to evaluate the impact of this product on hydration
status. Therefore, the purpose of this study is to determine the impact of Nuun Instant
powder and new product under development called Nuun Electrolyte on hydration status in young
and active men and women. We will follow a similar approach as used by Maughan and colleagues
(2016) to measure the fluid balance (the difference between the amount of water consumed and
passed as urine) and beverage hydration index (the relative amount of urine passed after
consumption of a drink compared to water), while also measuring plasma volume using the
method of Dill and Costill (1974).
Description:
Maintaining adequate hydration is essential to optimal health and athletic performance. When
individuals exercise (in particular in a warm environment), they can lose excessive amounts
of fluids through sweating, along with necessary electrolytes (e.g., sodium, potassium,
chloride). With dehydration, individuals may feel sluggish and can experience impaired
physical performance.
Many attempts have been made to improve and measure the hydration status of active
individuals. This typically involves the ingestion of fluids leading up to activity
(typically plain water), as well as the ingestion of fluids during the activity itself
(water, along with a diluted carbohydrate/electrolyte beverage). This approach seems to work
well; however, some debate remains over what the best fluid is to consume, in particular
related to the macronutrient type and the specific electrolyte mix.
Related to the above, it is well-accepted that electrolyte replenishment is of importance,
both during and following exercise-to aid in rehydration for subsequent bouts. Electrolytes
(sodium in particular) have been used for decades to aid athlete hydration and this has led
to the development of various sport drinks-which also include small amounts of carbohydrate
(e.g., Gatorade, Powerade). However, one problem with moderate to high carbohydrate ingestion
is that some individuals experience gastrointestinal (GI) upset following carbohydrate
ingestion before and during an event, despite very good physical performance outcomes. Due to
this GI upset, some individuals (in particular recreationally active individuals who are not
competing at high levels) rely on water alone or a very low concentrated carbohydrate
beverage, and seek a method to ingest the lost electrolytes as well.
The solution to the above issues for many athletes is the use of powder "stick packs" that
can be carried in bags and pockets, and simply dumped into a water bottle when needed,
shaken, and consumed. They are easy to transport and provide the needed carbohydrate, as well
as electrolytes to replace those that are lost through intense and/or long duration exercise.
We recently completed a study of Nuun electrolyte tablets, which provide 2 grams of
carbohydrate per serving and a combination of electrolytes, provided at a relatively low
percentage of the Daily Value (DV). The DV tells us how much a particular nutrient in a
serving of a food product contributes to a daily diet, based on a standard 2000 calorie diet.
Nuun tablets contain: calcium (13mg, 1%DV), sodium (300mg, 13%DV), potassium (150mg, 3%DV),
magnesium (25mg, 6%DV), and chloride (40mg, 2%DV). Our results indicated improved hydration
(based on urine output and the calculated hydration index) when subjects consumed the Nuun
tablets mixed into 1 liter of water, as compared to water alone.
Nuun Instant is a new product that is similar to the Nuun tablets, but is formulated for
those who may experience a significant electrolyte loss and is higher in carbohydrate as
well. Specifically, the Nuun Instant product contains (per 11 gram serving) the following: 7
grams of carbohydrate, calcium (20mg, 2%DV), sodium (520mg, 23%DV), potassium (385mg, 8%DV),
magnesium (8mg, 2%DV), chloride (250mg, 10%DV), and 100% of vitamin C (90mg) and B12 (2.4
mcg).
Nuun Electrolytes is a new product in development that is similar to the Nuun tablets, but
with an adjusted formula. Nuun Electrolytes consist of Citric Acid, Dextrose, Sodium
Bicarbonate, Potassium Bicarbonate, Sodium Carbonate, Natural Flavors, Potassium Chloride,
Malic Acid, Magnesium Carbonate, Calcium Carbonate, Stevia Leaf Extract, Beet Powder Color,
Safflower Oil. Nuun electrolytes contains (per tablet) the following: 3 grams of
carbohydrate, calcium (15 mg, 1%DV), sodium (200 mg, 9%DV), potassium (125mg, 3%DV),
magnesium (15mg, 4%DV), and chloride (75mg, 3%DV).
While Nuun Instant is commercially available and has received positive reviews from athletes,
there have been no studies to date to evaluate the impact of this product or Nuun Electrolyte
on hydration status. Therefore, the purpose of this study is to determine the impact of Nuun
Instant powder and Nuun Electrolyte tablets on hydration status in young and active men and
women. We will follow a similar approach as used by Maughan and colleagues (2016) to measure
the fluid balance (the difference between the amount of water consumed and passed as urine)
and beverage hydration index (the relative amount of urine passed after consumption of a
drink compared to water), while also measuring plasma volume using the method of Dill and
Costill (1974).
