HydrationNCT07921914
Dietary Supplementation and Hydration
A study testing protein supplement in people with Hydration, run by Loughborough University at 1 site in United Kingdom.
Trial summary
This study will examine the effects of protein drinks on markers of hydration in healthy young males and females. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Hydration
- What is being tested?
- protein supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Oct 2026to 1 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, physically active
Who cannot join
- Are not between the ages of 18-40. If you are not considered at least recreationally physically active (at least meeting the WHO criteria) - Tier 1 or Tier 2 on the Participant Classification Framework (https://pubmed.ncbi.nlm.nih.gov/34965513/).
- Have metabolic, inflammatory, vascular, renal disease or any other complication that would contradict the study procedures or risk your health.
- Currently taking medication or supplements that may interfere with the study outcomes.
- Do not satisfactorily complete the health history survey
- You have any allergies to the ingredients in the supplements
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
Loughborough University
Loughborough, Leicestershire
About this study
This study will examine the effects of protein drinks on markers of hydration in healthy young males and females.
- Conditions
- Hydration
- Being tested
- protein supplement, Placebo control
- Keywords
- Protein, Drink
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
protein supplementDietary supplement
10 g of protein powder in 500 ml water
protein supplementDietary supplement
10 g of protein powder, plus sodium chloride (20 mmol/L) in 500 ml of water
Placebo controlOther
Water (500 ml)
| Study group | Role | What they receive |
|---|---|---|
| Protein | Experimental | Protein (10 g of protein powder and 500 ml of water) Receives: Dietary Supplement: protein supplement |
| Protein+ | Experimental | Protein (10 g of protein powder, 500 ml of water, sodium chloride, 20 mmol/L) Receives: Dietary Supplement: protein supplement |
| Placebo control | Placebo comparator | Water (500 ml) Receives: Other: Placebo control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine output (mass in grams over 180 min collection period)
Measured: 180 minutes
Secondary outcomes (20)
Subjective measures of thirst (Likert scale, 0-10; 0 = low, 10 = high)
Measured: Pre - then 30, 60, 120, 180 mins post
Urine specific gravity (AU)
Measured: Pre - then 60, 120, 180 mins post
Blood sodium concentrations (mmol)
Measured: Pre - then 30, 60, 120, 180 mins post
Blood chloride concentrations (mmol)
Measured: Pre - then 30, 60, 120, 180 mins post
Blood potassium (mmol)
Measured: Pre - then 30, 60, 120, 180 mins post
Urine sodium (mmol)
Measured: Pre - then 30, 60, 120, 180 mins post
Urine chloride (mmol)
Measured: Pre - then 30, 60, 120, 180 mins post
Urine potassium (mmol)
Measured: Pre - then 30, 60, 120, 180 mins post
Plasma volume change (% change)
Measured: Pre - then 60, 180 minutes
Plasma albumin concentrations
ELISA measurement
Measured: Pre - then 60, 180 minutes
Plasma aldosterone concentrations
ELISA measurement
Measured: Pre - then 60, 180 minutes
Subjective measure of hunger (Likert scale, 0-10; 0 = low, 10 = high)
Measured: Pre - then 30, 60, 120, 180 mins post
Subjective measure of gastrointestinal stress (Likert scale, 0-10; 0 = low, 10 = high)
Measured: Pre - then 30, 60, 120, 180 mins post
Plasma insulin concentrations
ELISA measurement
Measured: Pre - then 60, 180 minutes
Subjective measures of hunger (Likert scale, 0-10; 0 = low, 10 = high)
Measured: Pre - then 30, 60, 120, 180 mins post
Subjective measures of stomach fullness (Likert scale, 0-10; 0 = low, 10 = high)
Measured: Pre - then 30, 60, 120, 180 mins post
Subjective measures of nausea (Likert scale, 0-10; 0 = low, 10 = high)
Measured: Pre - then 30, 60, 120, 180 mins post
Beverage hydration index (AU)
Calculated as the ratio of cumulative urine mass for water/cumulative urine mass of the test beverages
Measured: Pre - then 30, 60, 120, 180 mins post
Plasma osmolality (mOsm/L)
Measured: Pre - 60, 180 mins post
Blood glucose (mmol/L)
Measured: Pre - then 30, 60, 120, 180 mins post
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start30 Oct 2026 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HydrationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Loughborough University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tom Clifford, Loughborough University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07921914
- Sponsor's protocol ID
- 24748
- Status last verified
- Jun 2026
- First submitted
- 2 Nov 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Supplementation and Hydration
- ClinicalTrials.gov ID
- NCT07921914
- Acronym / sponsor ID
- 24748
- Conditions
- Hydration
- Keywords
- Protein, Drink
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Loughborough UniversityUniversity, hospital or other
- Study start
- 30 Oct 2026 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 6 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will examine the effects of protein drinks on markers of hydration in healthy young males and females.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Protein | Experimental | Dietary Supplement: protein supplementProtein (10 g of protein powder and 500 ml of water) |
| Protein+ | Experimental | Dietary Supplement: protein supplementProtein (10 g of protein powder, 500 ml of water, sodium chloride, 20 mmol/L) |
| Placebo control | Placebo comparator | Other: Placebo controlWater (500 ml) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy, physically active
Key exclusion criteria (5 listed)
- Are not between the ages of 18-40. If you are not considered at least recreationally physically active (at least meeting the WHO criteria) - Tier 1 or Tier 2 on the Participant Classification Framework (https://pubmed.ncbi.nlm.nih.gov/34965513/).
- Have metabolic, inflammatory, vascular, renal disease or any other complication that would contradict the study procedures or risk your health.
- Currently taking medication or supplements that may interfere with the study outcomes.
- Do not satisfactorily complete the health history survey
- You have any allergies to the ingredients in the supplements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| protein supplement10 g of protein powder in 500 ml water | Dietary supplement | Protein |
| protein supplement10 g of protein powder, plus sodium chloride (20 mmol/L) in 500 ml of water | Dietary supplement | Protein+ |
| Placebo controlWater (500 ml) | Other | Placebo control |
Primary outcome
Urine output (mass in grams over 180 min collection period)
Time frame: 180 minutes
20 secondary outcomes
Subjective measures of thirst (Likert scale, 0-10; 0 = low, 10 = high)
Time frame: Pre - then 30, 60, 120, 180 mins post
Urine specific gravity (AU)
Time frame: Pre - then 60, 120, 180 mins post
Blood sodium concentrations (mmol)
Time frame: Pre - then 30, 60, 120, 180 mins post
Blood chloride concentrations (mmol)
Time frame: Pre - then 30, 60, 120, 180 mins post
Blood potassium (mmol)
Time frame: Pre - then 30, 60, 120, 180 mins post
Urine sodium (mmol)
Time frame: Pre - then 30, 60, 120, 180 mins post
Urine chloride (mmol)
Time frame: Pre - then 30, 60, 120, 180 mins post
Urine potassium (mmol)
Time frame: Pre - then 30, 60, 120, 180 mins post
Plasma volume change (% change)
Time frame: Pre - then 60, 180 minutes
Plasma albumin concentrations
Time frame: Pre - then 60, 180 minutes
Plasma aldosterone concentrations
Time frame: Pre - then 60, 180 minutes
Subjective measure of hunger (Likert scale, 0-10; 0 = low, 10 = high)
Time frame: Pre - then 30, 60, 120, 180 mins post
Subjective measure of gastrointestinal stress (Likert scale, 0-10; 0 = low, 10 = high)
Time frame: Pre - then 30, 60, 120, 180 mins post
Plasma insulin concentrations
Time frame: Pre - then 60, 180 minutes
Subjective measures of hunger (Likert scale, 0-10; 0 = low, 10 = high)
Time frame: Pre - then 30, 60, 120, 180 mins post
Subjective measures of stomach fullness (Likert scale, 0-10; 0 = low, 10 = high)
Time frame: Pre - then 30, 60, 120, 180 mins post
Subjective measures of nausea (Likert scale, 0-10; 0 = low, 10 = high)
Time frame: Pre - then 30, 60, 120, 180 mins post
Beverage hydration index (AU)
Time frame: Pre - then 30, 60, 120, 180 mins post
Plasma osmolality (mOsm/L)
Time frame: Pre - 60, 180 mins post
Blood glucose (mmol/L)
Time frame: Pre - then 30, 60, 120, 180 mins post
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing protein supplement in people with Hydration, run by Loughborough University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urine output (mass in grams over 180 min collection period) (time frame: 180 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.