Digestive HealthNCT05303753
Protein-Prebiotic Wellbeing Study
A study testing fermented dairy protein with prebiotic fiber in people with Digestive Health and Quality of Life, run by Arizona State University at 1 site in United States.
Trial summary
Healthy participants with self-reported GI complaints will consume the protein supplement that they normally use for recovery purposes after exercise during a 3-week baseline period, followed by a 3-week intervention period in which they maintain usage of their product, but replace a part of this product with a… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Digestive Health, Quality of Life
- What is being tested?
- fermented dairy protein with prebiotic fiber
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jan 2022to 11 Jul 2022
- 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects living in Arizona in the USA
- Women/Men aged between 18-35 years
- Serious athletes (exercise at least 3 x per week)
- With or without GI tract issues due to sport or protein/diet intake
- 18.5 ≤ BMI ≤ 40 kg/m2
- No physical limitations (i.e. able to perform all activities associated with daily living in an independent manner).
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- Use of a protein supplement or sports food after at least one training per day 3 x per week
- Willing to slightly increase their protein supplement intake during the intervention phase for 21 consecutive days
- Stable weight during the last 4 weeks, without a focus on body weight reduction through limiting caloric intake
- Written informed consent
Who cannot join
- Daily use of (sport) supplements containing probiotics and/or prebiotics
- Smoking
- Self-reported cow's milk protein allergy
- Clinical lactose intolerance
- Clinical milk protein allergy
- House dust mite allergy
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- Diagnosed GI tract disorders or diseases
- Musculoskeletal disorders
- Metabolic disorders (such as diabetes)
- Use of any medications known to affect protein metabolism (i.e. corticosteroids, non-steroidal anti-inflammatories, or prescribed acne medications).
- Chronic use of gastric acid-suppressing medication or anti-coagulants
- Use of antibiotics or anti-inflammatory medication the past 2 weeks
- Blood donation in the past 2 months
- Pregnant/lactating women
- Athletes should not aim to lose body weight by reducing energy intake during the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Exploratory Study on the Effect of Fermented Dairy Protein With Prebiotic Fiber in Athletes
Healthy participants with self-reported GI complaints will consume the protein supplement that they normally use for recovery purposes after exercise during a 3-week baseline period, followed by a 3-week intervention period in which they maintain usage of their product, but replace a part of this product with a fermented dairy protein with prebiotic fiber. In addition, a group of healthy participants without self-reported GI complaints will serve as a reference group by consuming the protein supplement that they normally use for recovery purposes after exercise during a 3-week period.
Read the detailed description
A substantial number of athletes suffer from gastro-intestinal problems, which may impair performance and/or subsequent recovery. Also, gut barrier integrity is impaired with high-intensity training. Emerging studies are showing a positive correlation between the gut microbiome and muscle function, athletic performance, body composition, and natural energy levels. This study will perform an exploratory analysis of the well-being and digestive health of well-trained athletes, and assess the potential effect of fermented dairy protein with prebiotic fiber on these parameters.
Question 1: Does the 3-week supplementation of a fermented dairy protein with prebiotic fiber affect the self-reported digestive comfort compared to a 3-week baseline period? And additionally, will the quality of life (self-reported general well-being and states of mood) change with the use of this type of product?
Question 2: Does the 3-week supplementation of a fermented dairy protein with prebiotic fiber show an alteration in gut microbiota in comparison to a 3-week baseline period, while dietary intake remains unaffected?
Question 3: How is the 3-week supplementation of a fermented dairy protein with prebiotic fiber experienced by the participants (taste and concept liking)?
Question 4: Is there a difference in baseline gut microbiota between athletes with and athletes without self-reported GI complaints.
- Conditions
- Digestive Health, Quality of Life
- Being tested
- fermented dairy protein with prebiotic fiber
- Keywords
- Participants, Healthy subjects, Athlete, Women, Men, Fermented Dairy, Prebiotics, Gut microbiota, Self-reported, GI tract, Diet, Sleep
- Medical subject headings
- Multiple Endocrine Neoplasia Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fermented dairy protein with prebiotic fiberOther
During the intervention period, the participant will consume a new product and will reduce the amount of protein in their normal diet reflecting the protein content of the new product.
| Study group | Role | What they receive |
|---|---|---|
| Single group | Other | During a 3-week baseline period, participants with self-reported GI complaints consume their own protein supplement that they use for recovery purposes after exercise, followed by a 3-week intervention period in which they maintain usage of their own product, but replace a part of this product with a fermented dairy protein with prebiotic fiber. An additional reference group of athletes without self-reported GI complaints will also be followed during a 3-week period in which they consume their own protein supplement that they use for recovery purposes after exercise. Receives: Other: fermented dairy protein with prebiotic fiber |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in self-reported digestive comfort
Gastrointestinal Symptoms Rating Scores (GSRS-score: Average of all 5 sub-scores)
Measured: Baseline (day 0), after 21 days and after 42 days.
Change in daily self-reported digestive comfort
Daily variation of GI complaints (averaged itemized score 1-10)
Measured: Study period covering day 1 to day 21 compared to day 22-42.
Secondary outcomes (5)
Change in self-reported general wellbeing - Physical Health
Reported as physical wellbeing (Physical Health Questionnaire, PHX - average score 1-7 based on 14 items)
Measured: Baseline (day 0), after 21 days and after 42 days.
Change in self-reported general wellbeing - Psychological Distress
Reported as psychological distress (mental distress, K6 scale - average score 0-24).
Measured: Baseline (day 0), after 21 days and after 42 days.
Change in participants microbiota composition of fecal samples
16s microbial profiling
Measured: Baseline (day 0), after 21 days and after 42 days.
Change in dietary intake
24-hour dietary recalls (food group intake, energy and macro- and micronutrient)
Measured: Baseline (day 0), after 21 days and after 42 days.
Chane in self-reported states of mood
Profile of Mood States (POMS)
Measured: Baseline (day 0), after 21 days and after 42 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start26 Jan 2022
- Primary completion11 Jul 2022
- Study completion11 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digestive HealthStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Modifying diet by adding a fermented dairy protein with prebiotic fiber
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Collaborators
- FrieslandCampina
- Responsible party
- Sponsor
- Investigators
- Floris Wardenaar, PhD, Principal investigator, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05303753
- Sponsor's protocol ID
- STUDY00014399
- Status last verified
- Mar 2025
- First submitted
- 14 Feb 2022
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study on the Effect of Fermented Dairy Protein With Prebiotic Fiber in Athletes
- ClinicalTrials.gov ID
- NCT05303753
- Acronym / sponsor ID
- STUDY00014399
- Conditions
- Digestive Health, Quality of Life
- Keywords
- Participants, Healthy subjects, Athlete, Women, Men, Fermented Dairy, Prebiotics, Gut microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Collaborators
- FrieslandCampina
- Study start
- 26 Jan 2022 (actual)
- Primary completion
- 11 Jul 2022 (actual)
- Study completion
- 11 Jul 2022 (actual)
- First posted
- 31 Mar 2022 (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.
Healthy participants with self-reported GI complaints will consume the protein supplement that they normally use for recovery purposes after exercise during a 3-week baseline period, followed by a 3-week intervention period in which they maintain usage of their product, but replace a part of this product with a fermented dairy protein with prebiotic fiber. In addition, a group of healthy participants without self-reported GI complaints will serve as a reference group by consuming the protein supplement that they normally use for recovery purposes after exercise during a 3-week period.
Detailed description
A substantial number of athletes suffer from gastro-intestinal problems, which may impair performance and/or subsequent recovery. Also, gut barrier integrity is impaired with high-intensity training. Emerging studies are showing a positive correlation between the gut microbiome and muscle function, athletic performance, body composition, and natural energy levels. This study will perform an exploratory analysis of the well-being and digestive health of well-trained athletes, and assess the potential effect of fermented dairy protein with prebiotic fiber on these parameters.
Question 1: Does the 3-week supplementation of a fermented dairy protein with prebiotic fiber affect the self-reported digestive comfort compared to a 3-week baseline period? And additionally, will the quality of life (self-reported general well-being and states of mood) change with the use of this type of product?
Question 2: Does the 3-week supplementation of a fermented dairy protein with prebiotic fiber show an alteration in gut microbiota in comparison to a 3-week baseline period, while dietary intake remains unaffected?
Question 3: How is the 3-week supplementation of a fermented dairy protein with prebiotic fiber experienced by the participants (taste and concept liking)?
Question 4: Is there a difference in baseline gut microbiota between athletes with and athletes without self-reported GI complaints.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Modifying diet by adding a fermented dairy protein with prebiotic fiber
| Arm | Type | Receives |
|---|---|---|
| Single group | Other | Other: fermented dairy protein with prebiotic fiberDuring a 3-week baseline period, participants with self-reported GI complaints consume their own protein supplement that they use for recovery purposes after exercise, followed by a 3-week intervention period in which they maintain usage of their own product, but replace a part of this product with a fermented dairy protein with prebiotic fiber. An additional reference group of athletes without self-reported GI complaints will also be followed during a 3-week period in which they consume their own protein supplement that they use for recovery purposes after exercise. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Healthy subjects living in Arizona in the USA
- Women/Men aged between 18-35 years
- Serious athletes (exercise at least 3 x per week)
- With or without GI tract issues due to sport or protein/diet intake
- 18.5 ≤ BMI ≤ 40 kg/m2
Key exclusion criteria (15 listed)
- Daily use of (sport) supplements containing probiotics and/or prebiotics
- Smoking
- Self-reported cow's milk protein allergy
- Clinical lactose intolerance
- Clinical milk protein allergy
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 |
|---|---|---|
| fermented dairy protein with prebiotic fiberDuring the intervention period, the participant will consume a new product and will reduce the amount of protein in their normal diet reflecting the protein content of the new product. | Other | Single group |
Primary outcome
Change in self-reported digestive comfort
Time frame: Baseline (day 0), after 21 days and after 42 days.
Gastrointestinal Symptoms Rating Scores (GSRS-score: Average of all 5 sub-scores)
Change in daily self-reported digestive comfort
Time frame: Study period covering day 1 to day 21 compared to day 22-42.
Daily variation of GI complaints (averaged itemized score 1-10)
5 secondary outcomes
Change in self-reported general wellbeing - Physical Health
Time frame: Baseline (day 0), after 21 days and after 42 days.
Change in self-reported general wellbeing - Psychological Distress
Time frame: Baseline (day 0), after 21 days and after 42 days.
Change in participants microbiota composition of fecal samples
Time frame: Baseline (day 0), after 21 days and after 42 days.
Change in dietary intake
Time frame: Baseline (day 0), after 21 days and after 42 days.
Chane in self-reported states of mood
Time frame: Baseline (day 0), after 21 days and after 42 days.
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 3 Apr 2025.
- Individual participant dataSharing planned: No
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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.
Floris Wardenaar, PhD principal investigator
Arizona State 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 fermented dairy protein with prebiotic fiber in people with Digestive Health and Quality of Life, run by Arizona State 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 10 inclusion and 15 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 3 Apr 2025. 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. 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?
Change in self-reported digestive comfort (time frame: Baseline (day 0), after 21 days and after 42 days.). The study lists 2 primary outcomes in all. 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 3 Apr 2025.