Dietary Supplementation and Hydration

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

Study Overview

• Status: Not yet recruiting
• Conditions: Hydration
• Intervention / Treatment: Dietary supplement: protein supplement; Dietary supplement: protein supplement; Other: Placebo control

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Leicestershire
    • Loughborough, Leicestershire, United Kingdom
      • Loughborough University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy, physically active

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Protein; Protein (10 g of protein powder and 500 ml of water)	Dietary supplement: protein supplement; 10 g of protein powder in 500 ml water; Dietary supplement: protein supplement; 10 g of protein powder, plus sodium chloride (20 mmol/L) in 500 ml of water
Experimental: Protein+; Protein (10 g of protein powder, 500 ml of water, sodium chloride, 20 mmol/L)	Dietary supplement: protein supplement; 10 g of protein powder in 500 ml water; Dietary supplement: protein supplement; 10 g of protein powder, plus sodium chloride (20 mmol/L) in 500 ml of water
Placebo Comparator: Placebo control; Water (500 ml)	Other: Placebo control; Water (500 ml)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Urine output (mass in grams over 180 min collection period)	180 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective measures of thirst (Likert scale, 0-10; 0 = low, 10 = high)		Pre - then 30, 60, 120, 180 mins post
Urine specific gravity (AU)		Pre - then 60, 120, 180 mins post
Blood sodium concentrations (mmol)		Pre - then 30, 60, 120, 180 mins post
Blood chloride concentrations (mmol)		Pre - then 30, 60, 120, 180 mins post
Blood potassium (mmol)		Pre - then 30, 60, 120, 180 mins post
Urine sodium (mmol)		Pre - then 30, 60, 120, 180 mins post
Urine chloride (mmol)		Pre - then 30, 60, 120, 180 mins post
Urine potassium (mmol)		Pre - then 30, 60, 120, 180 mins post
Plasma volume change (% change)		Pre - then 60, 180 minutes
Plasma albumin concentrations	ELISA measurement	Pre - then 60, 180 minutes
Plasma aldosterone concentrations	ELISA measurement	Pre - then 60, 180 minutes
Subjective measure of hunger (Likert scale, 0-10; 0 = low, 10 = high)		Pre - then 30, 60, 120, 180 mins post
Subjective measure of gastrointestinal stress (Likert scale, 0-10; 0 = low, 10 = high)		Pre - then 30, 60, 120, 180 mins post
Plasma insulin concentrations	ELISA measurement	Pre - then 60, 180 minutes
Subjective measures of hunger (Likert scale, 0-10; 0 = low, 10 = high)		Pre - then 30, 60, 120, 180 mins post
Subjective measures of stomach fullness (Likert scale, 0-10; 0 = low, 10 = high)		Pre - then 30, 60, 120, 180 mins post
Subjective measures of nausea (Likert scale, 0-10; 0 = low, 10 = high)		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	Pre - then 30, 60, 120, 180 mins post
Plasma osmolality (mOsm/L)		Pre - 60, 180 mins post
Blood glucose (mmol/L)		Pre - then 30, 60, 120, 180 mins post

Collaborators and Investigators

• Sponsor: Loughborough University

Study record dates

Study Major Dates

• Study Start (Estimated): October 30, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: November 2, 2026
• First Submitted That Met QC Criteria: November 2, 2026
• First Posted (Actual): November 6, 2026

Study Record Updates

• Last Update Posted (Actual): November 6, 2026
• Last Update Submitted That Met QC Criteria: November 2, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Protein; Drink
• Other Study ID Numbers: 24748

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No