Fermented Dairy Protein for Digestive Health

Overseen By Kinta Schott, MS

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Arizona State University

Must not be taking: Corticosteroids, NSAIDs, Antibiotics, others

Disqualifiers: Smoking, Lactose intolerance, GI disorders, others

Compensation: Varies

Number of Visits: 8

114 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how a supplement made of fermented dairy protein and prebiotic fiber affects digestive health and general well-being in athletes. The first part examines athletes without stomach issues to determine if the supplement aids carbohydrate digestion. The second part focuses on athletes with stomach problems to assess whether the supplement improves their symptoms. Individuals who exercise at least twice a week, either competitively or recreationally, and reside in the Phoenix area may be suitable candidates for this study. As an unphased trial, this study provides a unique opportunity to contribute to understanding how natural supplements can enhance athletic performance and well-being.

Will I have to stop taking my current medications?

You may need to stop taking certain medications if they affect protein metabolism, such as corticosteroids, non-steroidal anti-inflammatories, or prescribed acne medications. Chronic use of gastric acid suppressing medication, anti-coagulants, and anti-inflammatory medication is also not allowed. If you are taking any of these, you might need to stop before joining the trial.

What prior data suggests that this supplement is safe for athletes?

Research has shown that fermented dairy products with added fiber are usually safe and easy to digest. Studies have found that they can alleviate stomach issues like pain and gas without causing harm. These foods often contain beneficial bacteria that can improve gut health and help those with digestive problems feel better. This suggests that the treatment should be safe for most people. However, individual differences exist, so consulting a doctor about any concerns before joining a clinical trial is advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard approach to digestive health, which often involves fiber supplements or probiotics alone, the fermented dairy protein with prebiotic fiber combines both elements into one treatment. This unique combination leverages the benefits of fermentation, which may enhance protein digestibility and gut health, alongside prebiotic fibers that nourish beneficial gut bacteria. Researchers are excited because this dual-action approach could offer a more comprehensive improvement in digestive health compared to existing options. Plus, the inclusion of fermented proteins might introduce a novel mechanism to support and balance the gut microbiome in a way that traditional supplements do not.

What evidence suggests that this trial's treatments could be effective for digestive health?

This trial will evaluate the effects of fermented dairy protein with prebiotic fiber on digestive health. Research has shown that fermented dairy protein with added fiber might help reduce stomach and digestive issues. Previous studies found it alleviated symptoms like stomach pain, bloating, and constipation in people with digestive problems. The healthy bacteria in fermented foods can improve gut health and lessen symptoms of digestive disorders. Early findings also suggest that this supplement can boost overall well-being. These benefits make it a promising option for those with digestive discomfort. Participants in this trial will receive either the fermented dairy protein with prebiotic fiber or a control protein supplement to compare their effects. ^{2 3 4 5 6}

Are You a Good Fit for This Trial?

This trial is for athletes who either have or don't have gastrointestinal (GI) complaints. It's split into two parts: one for those without GI issues to study carbohydrate malabsorption, and another for those with GI issues to confirm previous findings.

Inclusion Criteria

Healthy subjects living in the Phoenix area in AZ, USA during the study

I do not have any physical limitations from an injury.

BMI value between ≥18.5 and ≤30 kg/m2

Exclusion Criteria

I have been diagnosed with a metabolic disorder like diabetes.

Smoking

Clinical or self-perceived milk protein allergy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Familiarization

Participants undergo familiarization with exercise protocols and baseline measurements are taken

1 week

1 visit (in-person)

Treatment Part I

Participants receive a 3-week supplementation of fermented dairy protein with prebiotic fiber or placebo, followed by a 3-week washout period and crossover to the opposite supplement

9 weeks

4 visits (in-person) for exercise tests and sample collection

Treatment Part II

Participants receive a 3-week supplementation of fermented dairy protein with prebiotic fiber or placebo

3 weeks

2 visits (in-person) for exercise tests and sample collection

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Fermented Dairy Protein with Prebiotic Fiber

Trial Overview Researchers are testing a fermented dairy protein with prebiotic fiber supplement against a placebo. The first part of the study uses a crossover design over 9 weeks, while the second part uses a parallel design over 3 weeks.

How Is the Trial Designed?

Group I: Fermented dairy protein with prebiotic fiber Experimental Treatment 1 Intervention

During 3-week period participants consume a fermented dairy protein with prebiotic fiber. During Part I participants are randomly assigned to start with the experimental arm or the control arm, after a 3-week washout period, they will supplement again for 3 weeks with the opposite supplement (double blind, randomized cross-over trial). During Part II participants are randomly assigned to the experimental arm only (double blind, randomized parallel trial).

Group II: Control protein supplement Placebo Group 1 Intervention

During 3-week period participants consume a control supplement. During Part I participants are randomly assigned to start with the control arm or the experimental arm, after a 3-week washout period, they will supplement again for 3 weeks with the opposite supplement (double blind, randomized cross-over trial). During Part II participants are randomly assigned to the control arm only (double blind, randomized parallel trial).

Who Is Running the Clinical Trial?

Arizona State University

Lead Sponsor

Trials

311

Recruited

109,000+

Friesland Campina

Collaborator

Trials

2

Recruited

80+

Published Research Related to This Trial

Whey fermented with the probiotic Lactobacillus rhamnosus significantly improved gastrointestinal health in a mouse model of ulcerative colitis, reducing disease activity and enhancing blood and tissue health indicators.

The consumption of this fermented whey led to lower levels of pro-inflammatory markers and higher levels of anti-inflammatory cytokines, suggesting it helps maintain intestinal barrier integrity and immune balance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protective effects of potential probiotic Lactobacillus rhamnosus (MTCC-5897) fermented whey on reinforcement of intestinal epithelial barrier function in a colitis-induced murine model. Kaur, H., Gupta, T., Kapila, S., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12154003/

Fermented Dairy Products as Precision Modulators of Gut ... Probiotic-enriched fermented dairy formulations have demonstrated clear benefits in mitigating intestinal inflammation and restoring epithelial ...

2. trialx.com trialx.com/clinical-trials/listings/297720/effect-of-a-fermented-dairy-protein-with-prebiotic-fiber-on-gi-complaints/

Effect of a Fermented Dairy Protein With Prebiotic Fiber on ... A positive impact of a fermented dairy protein with prebiotic fiber supplement on self-reported GI complaints and wellbeing has been ...

3. withpower.com withpower.com/trial/fermented-dairy-protein-for-digestive-health-8873c

Fermented Dairy Protein for Digestive Health Research shows that fermented foods, like those containing probiotic bacteria, can improve gut health and reduce symptoms in gastrointestinal disorders.

4. academic.oup.com academic.oup.com/nutritionreviews/advance-article/doi/10.1093/nutrit/nuaf114/8211971

Impact of Fermented Dairy on Gastrointestinal Health and ... Improvements in GI symptoms, such as abdominal pain or discomfort, flatulence, constipation, and IBS severity, were found in most studies for ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1756464620302838

New perspectives in fermented dairy products and their ... Fermented dairy products are a source of probiotics, prebiotics and bioactive compounds. Many studies feature multiple health benefits of fermented dairy ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06946017

Effect of a Fermented Dairy Protein With Prebiotic Fiber on ... A positive impact of a fermented dairy protein with prebiotic fiber supplement on self-reported GI complaints and wellbeing has been suggested (Wardenaar et ...