- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06165523
Kefir Versus Milk on Time-Trial Performance in Masters Athletes (KVM)
December 8, 2023 updated by: Lindenwood University
Effect of Flavored Kefir Versus Flavored Milk on Time-Trial Performance in Endurance Master Athletes
The purpose of this study is to determine the effects of added probiotic cultures to a carbohydrate + protein recovery beverage compared to a similar recovery beverage without probiotic cultures, in its ability to impact endurance performance, perceived ratings of gastrointestinal symptoms and markers of inflammation and intestinal damage.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
In a randomized, crossover fashion, the investigators will assess changes in exercise performance, gastrointestinal symptom rating scale scores, as well as interleukin-6 and intestinal fatty-acid binding protein levels following consumption of either water, kefir or flavored milk.
Study Type
Interventional
Enrollment (Actual)
11
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
-
-
Missouri
-
Saint Charles, Missouri, United States, 63301
- Exercise and Performance Nutrition Laboratory
-
-
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
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Provide voluntary signed and dated informed consent.
- Be in good health as determined by medical history and routine blood chemistries.
- Normotensive (seated, resting systolic blood pressure < 140 mm Hg and diastolic blood pressure < 90 mm Hg. If the first measurement is slightly elevated above these limits, the subject will be given a brief (5 minute) rest period, and two more measurements will be taken. The average of all three measurements will be used to determine eligibility.
- Normal seated, resting heart rate (< 90 beats per minute).
- Age between 40 and 75 years of age
- Body Mass Index <30 kg/m2 or Body Fat <30% for females and <25% for males
- Performing aerobic exercise > 150 mins/week and training for at least 3 years
- Well-trained will be defined as athletes that meet two of the four following criteria: training frequency is 3-7 sessions/week; duration of training sessions is 60-240 min; training background is at least 3 y; race frequency is at least once a year.
Exclusion Criteria:
- Individuals currently diagnosed or being treated for any cardiac, respiratory, endocrine, psychiatric, musculoskeletal, renal, hepatic, neuromuscular or metabolic disease or disorder that in the judgement of the study participant's personal physician or research nurse that will preclude their safe participation or will contraindicate quality control over the collected data
- Individuals currently diagnosed with or are being treated for celiac disease, lactose intolerance, digestive insufficiencies or other gastrointestinal complications such as irritable bowel syndrome, ulcerative colitis, etc.
Alcohol consumption (more than 2 standard alcoholic drinks per day or more than 10 drinks per week) or drug abuse or dependence.
- Smokers or individuals who have quit smoking within the last 6 months
- Participants that are unwilling to refrain from caffeine, nicotine, and alcohol intake for 12 hours prior to each study visit.
- Known sensitivity to any ingredient in the test formulations as listed in the Nutrition Facts label.
- Individuals who are determined to be on a ketogenic diet.
- Individuals who are cognitively impaired and/or who are unable to give informed consent.
- Participants that are unwilling to refrain from taking biotin at a minimum of 72 hours before visit 3 through the end of the study due to potential interference with laboratory analyses.
- Individuals taking a medication known to impact digestive function or hormonal functions that may impact how our body digests, absorbs or metabolizes nutrients
- Individuals that are currently taking a probiotic or a dietary supplement that may impact digestive function or hormonal function that may impact how our body digests, absorbs or metabolizes nutrients
- Participants that are unwilling to refrain from fermented foods and yogurt, as well as maintain normal consumption levels of prebiotics throughout the study.
- Pregnant women, women trying to become pregnant, or nursing women.
- Individuals who indicate they are actively restricting calories or attempting to lose weight.
- Participants that are unwilling to keep their self-directed training protocols the same throughout the course of the study
- Participants that are unwilling to wear the same shoes and similar clothing for all testing visits.
- Individuals who participate in aerobic exercise < 2 days/week or have been aerobically training < 3 years
- Individuals that do not meet the criteria to be defined as well-trained
- Unwillingness to intake a supplement or follow the study protocol
- Any other condition which in the investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose a significant risk to the subject.
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: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Water
|
340 mL plain tap water consumed immediately following glycogen depleting exercise
|
Experimental: Flavored Kefir
1% Lowfat Kefir manufactured by Lifeway Kefir and containing 18 g of CHO, 10 g of protein, and 2 g of fat
|
320 mL kefir consumed immediately following glycogen depleting exercise
|
Active Comparator: Flavored Milk
1% Lowfat Milk manufactured by Prairie Farms and containing 24 g of CHO, 8 g of protein, and 2.5 g of fat
|
240 mL flavored milk consumed immediately following glycogen depleting exercise
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Aerobic Performance Times
Time Frame: Through study completion, an average of 3 weeks
|
5 kilometer running time-trial on a curved, non-motorized treadmill
|
Through study completion, an average of 3 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood Interleukin-6
Time Frame: Through study completion, an average of 3 weeks
|
Blood interleukin-6 concentrations in response to intense exercise
|
Through study completion, an average of 3 weeks
|
Blood Intestinal fatty-acid binding protein
Time Frame: Through study completion, an average of 3 weeks
|
Blood Intestinal fatty-acid binding protein concentrations in response to intense exercise
|
Through study completion, an average of 3 weeks
|
Gastrointestinal Symptoms
Time Frame: Through study completion, an average of 3 weeks
|
Gastrointestinal Symptoms measured using the Gastrointestinal Symptoms Rating Scale (GSRS) in response to intense exercise.
The scale asks 15 questions, and asks participants to rate their gastrointestinal symptoms on a 7 point scale with 0 being no discomfort at all and 7 being very severe discomfort.
Lower total GSRS scores indicate a better outcome.
|
Through study completion, an average of 3 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Chad M Kerksick, PhD, Lindenwood University
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)
March 7, 2023
Primary Completion (Actual)
August 15, 2023
Study Completion (Actual)
August 15, 2023
Study Registration Dates
First Submitted
November 16, 2023
First Submitted That Met QC Criteria
December 8, 2023
First Posted (Estimated)
December 11, 2023
Study Record Updates
Last Update Posted (Estimated)
December 11, 2023
Last Update Submitted That Met QC Criteria
December 8, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- IRB-23-71
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
The investigators do not plan to make IPD available to other researchers
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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