Gastrointestinal ComplicationKVMNCT06165523
Kefir Versus Milk on Time-Trial Performance in Masters Athletes
A study testing Water, Flavored Kefir and Flavored Milk in people with Gastrointestinal Complication and Exercise Performance, run by Lindenwood University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Complication, Exercise Performance, Aerobic Endurance
- What is being tested?
- Water, Flavored Kefir and Flavored Milk
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Mar 2023to 15 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Exercise and Performance Nutrition Laboratory
Saint Charles, Missouri, 63301
About this study
Official title: 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.
Read the 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.
- Being tested
- Water, Flavored Kefir, Flavored Milk
- Keywords
- Kefir, Milk, Aerobic Endurance, Exercise Performance, Gastrointestinal Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WaterOther
340 mL plain tap water consumed immediately following glycogen depleting exercise
Flavored KefirOther
320 mL kefir consumed immediately following glycogen depleting exercise
Flavored MilkOther
240 mL flavored milk consumed immediately following glycogen depleting exercise
| Study group | Role | What they receive |
|---|---|---|
| Water | Placebo comparator | Water Receives: Other: Water |
| Flavored Kefir | Experimental | 1% Lowfat Kefir manufactured by Lifeway Kefir and containing 18 g of CHO, 10 g of protein, and 2 g of fat Receives: Other: Flavored Kefir |
| Flavored Milk | Active comparator | 1% Lowfat Milk manufactured by Prairie Farms and containing 24 g of CHO, 8 g of protein, and 2.5 g of fat Receives: Other: Flavored Milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aerobic Performance Times
5 kilometer running time-trial on a curved, non-motorized treadmill
Measured: Through study completion, an average of 3 weeks
Secondary outcomes (3)
Blood Interleukin-6
Blood interleukin-6 concentrations in response to intense exercise
Measured: Through study completion, an average of 3 weeks
Blood Intestinal fatty-acid binding protein
Blood Intestinal fatty-acid binding protein concentrations in response to intense exercise
Measured: Through study completion, an average of 3 weeks
Gastrointestinal Symptoms
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.
Measured: Through study completion, an average of 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start7 Mar 2023
- Primary completion15 Aug 2023
- Study completion15 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, crossover.
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lindenwood University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chad M Kerksick, PhD, Principal investigator, Lindenwood University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06165523
- Sponsor's protocol ID
- IRB-23-71
- Acronym
- KVM
- Status last verified
- Dec 2023
- First submitted
- 16 Nov 2023
- Last updated
- 11 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators do not plan to make IPD available to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Flavored Kefir Versus Flavored Milk on Time-Trial Performance in Endurance Master Athletes
- ClinicalTrials.gov ID
- NCT06165523
- Acronym / sponsor ID
- KVM / IRB-23-71
- Keywords
- Kefir, Milk, Aerobic Endurance, Exercise Performance, Gastrointestinal Symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Lindenwood UniversityUniversity, hospital or other
- Study start
- 7 Mar 2023 (actual)
- Primary completion
- 15 Aug 2023 (actual)
- Study completion
- 15 Aug 2023 (actual)
- First posted
- 11 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomized, crossover.
| Arm | Type | Receives |
|---|---|---|
| Water | Placebo comparator | Other: WaterWater |
| Flavored Kefir | Experimental | Other: Flavored Kefir1% Lowfat Kefir manufactured by Lifeway Kefir and containing 18 g of CHO, 10 g of protein, and 2 g of fat |
| Flavored Milk | Active comparator | Other: Flavored Milk1% Lowfat Milk manufactured by Prairie Farms and containing 24 g of CHO, 8 g of protein, and 2.5 g of fat |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Water340 mL plain tap water consumed immediately following glycogen depleting exercise | Other | Water |
| Flavored Kefir320 mL kefir consumed immediately following glycogen depleting exercise | Other | Flavored Kefir |
| Flavored Milk240 mL flavored milk consumed immediately following glycogen depleting exercise | Other | Flavored Milk |
Primary outcome
Aerobic Performance Times
Time frame: Through study completion, an average of 3 weeks
5 kilometer running time-trial on a curved, non-motorized treadmill
3 secondary outcomes
Blood Interleukin-6
Time frame: Through study completion, an average of 3 weeks
Blood Intestinal fatty-acid binding protein
Time frame: Through study completion, an average of 3 weeks
Gastrointestinal Symptoms
Time frame: Through study completion, an average of 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
- Individual participant dataSharing planned: No. The investigators do not plan to make IPD available to other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chad M Kerksick, PhD principal investigator
Lindenwood University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Water, Flavored Kefir and Flavored Milk in people with Gastrointestinal Complication and Exercise Performance, run by Lindenwood University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aerobic Performance Times (time frame: Through study completion, an average of 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2023.