- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07456683
The Effect of Water With Anti-Inflammatory Capabilities on the Inflammatory Response to Heavy Resistance Exercise (WAC)
March 2, 2026 updated by: Brendon P. McDermott, University of Arkansas, Fayetteville
The purpose of this research is to assess the anti-inflammatory effects of berry-flavored water in response to an acute bout of exercise.
This investigation is part of a larger collaborative project between the Exercise Science Research Center, the Center for Human Nutrition, and the University of Arkansas Sensory Science Center, which seeks to examine the potential of waters infused with naturally occurring bioactive anti-inflammatory volatile compounds to improve overall health.
We expect that this water infused with natural bioactive berry volatile compounds will demonstrate preventive physiological benefits in relation to systemic inflammation, including a decreased level of baseline (resting) inflammation and attenuated post-exercise inflammation.
Study Overview
Status
Completed
Conditions
Detailed Description
Participants will be asked to refrain from eating berries for 48 hours, drinking alcohol for 24 hours and consuming caffeine for 12 hours prior to reporting for their baseline test, and all subsequent visits to the lab.
This will be confirmed via self-report form.
All visits to the lab will be completed between the hours of 0700 and 0900 in order to ensure each participant arrives fasted.
For baseline testing, occurring on Day 0, participants will determine their 1 repetition maximum (1RM) back squat using standardized protocols set forth by the National Strength and Conditioning Association.
Following their 1RM determination, participants will receive a dual energy X-ray absorption scan to determine body composition.
On Day 6, 24 hours leading into the next visit, participants will be asked to record food and fluid intake via a standard diet log and collect urine output in a urine collection jug for 24 hours.
This visit will require participants to come to the lab to pick up a diet log and urine collection jug.
On Day 7, participants will report to the lab and offer a blood sample from an antecubital vein.
They will then undergo a standardized warm up, which will consist of 5 minutes at a self-selected pace on a treadmill, followed by two sets of 10 body weight squats, 10 glute bridges, and 10 lunges on each leg.
Following the warmup, participants will complete an acute heavy resistance exercise protocol (AHREP), which will consist of 6x10 repetition maximum (10RM) back squat, with two minutes rest between sets.
This protocol was chosen due to its effectiveness in eliciting a large inflammatory response in other studies.
Working set load will be estimated by taking 75% the 1RM weight, which estimates 10RM.
Following each set, participants will be asked to rate their effort on a scale of 6-20.
Immediately following completion of the exercise, participants will provide another blood sample, before a standardized cool down where they will be asked to walk at a comfortable pace on a treadmill.
On Day 8, approximately 24 hours after completion of AHREP1, participants will return to the lab for another blood draw and complete a muscle soreness questionnaire and a self-reported muscle function questionnaire.
Prior to leaving the lab, they will be given 42 bottles containing 16.9ozs of berry-infused water, or plain water, which they will be instructed to drink 2 times per day, starting after they leave the lab.
On Day 9, approximately 48 hours after completion of AHREP1, the participants return to the lab for another blood draw and another muscle soreness questionnaire.
On Day 27, 24 hours leading into the next visit, participants will be asked to record food and fluid intake via a standard diet log and collect urine output in a urine collection jug for 24 hours.
This visit will require participants to come to the lab to pick up a diet log and urine collection jug.
On Day 28 of the study, participants will return to the lab as a compliance check.
They will receive another 42 drinks, (berry-infused water or plain water) as well as offer a blood sample.
They will fill out a Pittsburg Sleep Quality Index form and a Profile of Mood States form.
On Day 41, 24 hours leading into the next visit, participants will be asked to record food and fluid intake via a standard diet log and collect urine output in a urine collection jug for 24 hours.
This visit will require participants to come to the lab to pick up a diet log and urine collection jug.
On Day 42 of the study, participants return to the lab and offer a blood sample.
They will then undergo a standardized warm up.
Following the warmup, participants will complete a second AHREP.
Immediately following completion of the exercise, participants will provide another blood sample, before a standardized cool down where they will be asked to walk at a comfortable pace on a treadmill.
On Day 43, approximately 24 hours after completion of AHREP2, participants will return to the lab for another blood draw and complete a muscle soreness questionnaire and a self-perceived function questionnaire.
On Day 44, approximately 48 hours after completion of AHREP2, the participants return to the lab for another blood draw and another muscle soreness questionnaire and self-perceived function questionnaire.
At this point the participation in the study will be concluded and participants compensated for their efforts.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arkansas
-
Fayetteville, Arkansas, United States, 72701
- University of Arkansas Exercise Science Research Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Sedentary to moderately active, as defined by the International Physical Activity Questionnaire (IPAQ)
Exclusion Criteria:
- Kidney, liver, cardiac, or immune conditions that may compromise their health Not used to lifting weights more than 1 time per month. Participants identified as being 'high fruit/vegetable consumers' will also be excluded from the study because they habitually consume polyphenols and antioxidants already exhibiting anti-inflammatory effects that would compromise our findings.
A history of fainting from routine blood draws.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Consuming WAC beverage for 6 weeks
|
Participants consumed 1L of special water every day for 6 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Inflammation
Time Frame: Baseline, Post-lifting, day 1 post, day 2 post, 3-week post, baseline 2, post-lifting 2, day1 (2), day 2 (2). All over a 6-wk period
|
Innflammatory biomarkers
|
Baseline, Post-lifting, day 1 post, day 2 post, 3-week post, baseline 2, post-lifting 2, day1 (2), day 2 (2). All over a 6-wk period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 17, 2021
Primary Completion (Actual)
February 10, 2024
Study Completion (Actual)
February 10, 2024
Study Registration Dates
First Submitted
March 2, 2026
First Submitted That Met QC Criteria
March 2, 2026
First Posted (Actual)
March 6, 2026
Study Record Updates
Last Update Posted (Actual)
March 6, 2026
Last Update Submitted That Met QC Criteria
March 2, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- 2102314312
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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