ClinicalTrials.gg
Not yet recruitingNCT07921914Updated Nov 6, 2026

Dietary Supplementation and Hydration

An interventional study of protein supplement and protein supplement in Hydration, sponsored by Loughborough University. Not yet recruiting at 1 site in United Kingdom. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-06.

Sponsored by Loughborough University · Not applicable, Interventional, and Treatment

Updated Nov 6, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
All
01

Study summary

This study will examine the effects of protein drinks on markers of hydration in healthy young males and females.

02

Conditions studied

  • Hydration

Keywords

  • Protein
  • Drink
03

In context

Lead sponsor

Loughborough University is the lead sponsor of 76 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Healthy, physically active

Exclusion criteria

Exclusion Criteria:

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
15 participants (estimated)

Study arms

  • Experimental
    Protein

    Protein (10 g of protein powder and 500 ml of water)

    Dietary Supplement: protein supplement

  • Experimental
    Protein+

    Protein (10 g of protein powder, 500 ml of water, sodium chloride, 20 mmol/L)

    Dietary Supplement: protein supplement

  • Placebo comparator
    Placebo control

    Water (500 ml)

    Other: Placebo control

Interventions

  • Dietary supplementprotein supplement

    10 g of protein powder in 500 ml water

  • Dietary supplementprotein supplement

    10 g of protein powder, plus sodium chloride (20 mmol/L) in 500 ml of water

  • OtherPlacebo control

    Water (500 ml)

06

What researchers measure

Primary outcomes

  1. Urine output (mass in grams over 180 min collection period)

    Time frame: 180 minutes

Secondary outcomes

  1. Subjective measures of thirst (Likert scale, 0-10; 0 = low, 10 = high)

    Time frame: Pre - then 30, 60, 120, 180 mins post

  2. Urine specific gravity (AU)

    Time frame: Pre - then 60, 120, 180 mins post

  3. Blood sodium concentrations (mmol)

    Time frame: Pre - then 30, 60, 120, 180 mins post

  4. Blood chloride concentrations (mmol)

    Time frame: Pre - then 30, 60, 120, 180 mins post

  5. Blood potassium (mmol)

    Time frame: Pre - then 30, 60, 120, 180 mins post

  6. Urine sodium (mmol)

    Time frame: Pre - then 30, 60, 120, 180 mins post

  7. Urine chloride (mmol)

    Time frame: Pre - then 30, 60, 120, 180 mins post

  8. Urine potassium (mmol)

    Time frame: Pre - then 30, 60, 120, 180 mins post

  9. Plasma volume change (% change)

    Time frame: Pre - then 60, 180 minutes

  10. Plasma albumin concentrations

    ELISA measurement

    Time frame: Pre - then 60, 180 minutes

  11. Plasma aldosterone concentrations

    ELISA measurement

    Time frame: Pre - then 60, 180 minutes

  12. Subjective measure of hunger (Likert scale, 0-10; 0 = low, 10 = high)

    Time frame: Pre - then 30, 60, 120, 180 mins post

  13. Subjective measure of gastrointestinal stress (Likert scale, 0-10; 0 = low, 10 = high)

    Time frame: Pre - then 30, 60, 120, 180 mins post

  14. Plasma insulin concentrations

    ELISA measurement

    Time frame: Pre - then 60, 180 minutes

  15. Subjective measures of hunger (Likert scale, 0-10; 0 = low, 10 = high)

    Time frame: Pre - then 30, 60, 120, 180 mins post

  16. Subjective measures of stomach fullness (Likert scale, 0-10; 0 = low, 10 = high)

    Time frame: Pre - then 30, 60, 120, 180 mins post

  17. Subjective measures of nausea (Likert scale, 0-10; 0 = low, 10 = high)

    Time frame: Pre - then 30, 60, 120, 180 mins post

  18. Beverage hydration index (AU)

    Calculated as the ratio of cumulative urine mass for water/cumulative urine mass of the test beverages

    Time frame: Pre - then 30, 60, 120, 180 mins post

  19. Plasma osmolality (mOsm/L)

    Time frame: Pre - 60, 180 mins post

  20. Blood glucose (mmol/L)

    Time frame: Pre - then 30, 60, 120, 180 mins post

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Nov 6, 2026
Show all 1 update
  1. Nov 6, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07921914
Lead sponsor
Loughborough University
Responsible party
Tom Clifford (Reader in Exercise and Health Nutrition, Principal Investigator, Loughborough University) — Principal investigator
First posted
Nov 6, 2026
Start date
Oct 30, 2026 (estimated)
Primary completion
Oct 1, 2027 (estimated)
Completion
Oct 1, 2027 (estimated)
Last update
Nov 6, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Protein Supplement

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