NCT06698237

Brief Summary

In order to optimize sports performance, high-level athletes are required to manage conflicting training objectives, which often result in periods of high-volume training. These athletes need to perform heavy resistance training sessions to promote physiological adaptations, which consequently induce fatigue. Yet, they need to minimize fatigue to perform subsequent high-quality training sessions often within the same day. To support these training endeavours, a high-quality dietary regimen and adequate protein consumption is deemed to be an essential component of an athlete's recovery plan, as it has been shown to support muscle recovery and reduce muscle inflammation following exercise. Indeed, current sports nutrition recommendations advocate for the consumption of dietary protein and carbohydrate after exercise to promote tissue repair and replenish muscle energy stores (glycogen). Additionally, previous research has shown how water immersion therapies post-exercise may alleviate fatigue and restore performance. However, little is known about how different temperatures, as well as timing of cold-water immersion can support performance recovery in a population of athletes adhering to contemporary post-exercise nutrition recommendations. The objective of this project is to investigate the effects of timing of cold-water immersion relative to exercise on performance recovery within the same day, as well as to investigate whether cold water immersion augments blood amino acid concentrations after exercise and protein intake.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
4mo left

Started Dec 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress81%
Dec 2024Sep 2026

First Submitted

Initial submission to the registry

November 14, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 20, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

December 20, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 3, 2025

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Expected
Last Updated

April 9, 2026

Status Verified

April 1, 2026

Enrollment Period

11 months

First QC Date

November 14, 2024

Last Update Submit

April 7, 2026

Conditions

Keywords

Cold-water immersionProteinPerformanceAthleteExercise physiologyNutritionExerciseResistance trainingSport recoveryAminoacidemiacold-therapystrength training

Outcome Measures

Primary Outcomes (1)

  • Prolonged maximum voluntary isometric contraction of the knee extensors peak force

    The participant will be asked to perform one five-second maximum voluntary isometric contraction of the knee extensors on an isometric dynamometer at a 60° angle of the knee joint. The force-time profile will be used to derive the peak force (Newton)

    120 minutes prior to water immersion, immediately prior to water immersion, 300 minutes post protein intake.

Secondary Outcomes (45)

  • postprandial plasma total amino acid concentration incremental area-under-the-curve

    -120, 0, 15, 30, 45, 60, 90, 120, 180, 240, 300 minutes in the post-prandial period

  • postprandial plasma branched chain amino acid concentration incremental area-under-the-curve

    -120, 0, 15, 30, 45, 60, 90, 120, 180, 240, 300 minutes in the post-prandial period

  • postprandial plasma essential amino acid concentration incremental area-under-the-curve

    -120, 0, 15, 30, 45, 60, 90, 120, 180, 240, 300 minutes in the post-prandial period

  • postprandial plasma leucine concentration incremental area-under-the-curve

    -120, 0, 15, 30, 45, 60, 90, 120, 180, 240, 300 minutes in the post-prandial period

  • Postprandial plasma glucose concentration incremental area-under-the-curve

    -120, 0, 15, 30, 45, 60, 90, 120, 180, 240, 300 minutes in the post-prandial period

  • +40 more secondary outcomes

Study Arms (3)

CWI_0

EXPERIMENTAL

immediate cold-water immersion

Other: immediate cold-water immersion

CWI_3

EXPERIMENTAL

3 hour delayed cold water immersion

Other: delayed cold-water immersion

THERM

ACTIVE COMPARATOR

immediate thermoneutral water immersion

Other: immediate thermoneutral water immersion

Interventions

immediate 10 minute water immersion in 10 degree Celsius

CWI_0

3 hour delayed 10 minute water immersion in 10 degree Celsius

CWI_3

immediate 10 minute water immersion in 35 degree Celsius

THERM

Eligibility Criteria

Age18 Years - 40 Years
Sexall(Gender-based eligibility)
Gender Eligibility Detailscis-male and cis-female
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • To be eligible to participate in this study, a participant must meet all the following criteria:
  • Healthy adult between 18 - 40 years (inclusive).
  • Individual with a BMI between \>18.5 and \<30 kg/m2 (inclusive).
  • Individual who is in good general health (no uncontrolled diseases or conditions).
  • individual with a history of regular resistance training ≥2 per week for the past six-months.
  • Individual who is currently competing at the varsity, provincial, national or international level in their respective sport.
  • Individual who is free from any musculoskeletal injuries and/or conditions that might affect their ability to perform resistance exercises or undergo cold-water immersion.
  • Individual who has maintained stable use of medication and/or supplements, stable dietary and lifestyle habits, and stable body weight (weight loss or gain \<3 kg), for the last three-months prior to screening.
  • Individual who agrees to maintain usual training habits between sessions.

You may not qualify if:

  • Individual who is lactating, pregnant or planning to become pregnant during the study.
  • Females with irregular menstrual cycles (defined as outside 24-38 days cycle range, based on self-reports).
  • Individual who adheres to a diet (e.g., vegan diet) that restricts consumption of dairy products.
  • Has a known sensitivity, intolerability, or allergy to any of the study products or their excipients (i.e., lactose intolerant).
  • Weight loss or gain \> 3 kg in the 3 months prior to study visit 1.
  • Currently or planning to be on a weight loss regimen during the study.
  • Recent (within 2 weeks of screening visit) history of an episode of acute GI illness such as nausea/vomiting or diarrhea.
  • Have a history of irritable bowel disease (IBS), inflammatory bowel disease (IBD, including ulcerative colitis and Crohn's disease), functional constipation or diarrhea (defined by the Rome IV diagnostic criteria), celiac disease, malabsorption, gastroparesis, diverticulosis, gastric or duodenal ulcers, pancreatitis, or eating disorder; or have a history of intestinal surgery (excluding appendectomy or herniorrhaphy) or bariatric surgery.
  • Have an abnormality or obstruction of the gastrointestinal tract precluding swallowing (e.g., dysphagia) and/or digestion (e.g., history of bowel obstruction).
  • Participated in upper gastrointestinal endoscopy and/or colonoscopy or preparation within 3 months prior to screening visit.
  • Diagnosed with hypercholesterolemia or hypertriglyceridemia (i.e., elevated fasting low- density lipoprotein (LDL) (≥ 135 mg·dL-1; ≥ 3.5 mmol·L-1) or elevated triglycerides (≥ 150 mg·dL-1; ≥1.7 mmol·L-1).
  • Has a history of heart disease/cardiovascular disease, uncontrolled hypertension (≥ 140 systolic or ≥ 90 diastolic mmHg), kidney disease (dialysis or renal failure), hepatic impairment or disease.
  • Is Type I or Type II diabetic or pre-diabetic \[i.e., elevated fasting blood glucose levels (≥ 100 mg·dL-1; ≥ 5.6 mmol·L-1) and/or elevated hemoglobin A1c (≥ 6.0%)\].
  • Has a history of liver or gallbladder disease or stomach ulcers.
  • Has a positive medical history of unstable thyroid disease, previously diagnosed major affective disorder, psychiatric disorder that required hospitalization in the prior year, immune disorders and/or immunocompromised (e.g., HIV/AIDS).
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McGill University

Montreal, Quebec, H2W 1S4, Canada

RECRUITING

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Tyler Churchward-Venne, PhD

CONTACT

Thalia Krauth-Ibarz, BSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: randomized crossover design, 12 participants (6 male and 6 female)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 14, 2024

First Posted

November 20, 2024

Study Start

December 20, 2024

Primary Completion

November 3, 2025

Study Completion (Estimated)

September 1, 2026

Last Updated

April 9, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations