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

Trial Summary

What is the purpose of this trial?

A positive impact of a fermented dairy protein with prebiotic fiber supplement on self-reported GI complaints and wellbeing has been suggested (Wardenaar et al. 2024). The following project aims to further investigate the impact of this supplements in athletes with and without GI complaints in two separate data collections. Part I of the data collection aims to investigate the impact of this supplement vs. a placebo on carbohydrate malabsorption (as a potential cause for GI distress) in athletes that normally don't identify as having GI complaints (randomized double-blind cross over study design covering a total of 9 weeks, including a 3-week washout period). Part II of the data collection aims to confirm the earlier found results in the previous study (Wardenaar et al. 2024) in a group athletes self-reporting GI complaints that will be randomized into an intervention group or a placebo group (randomized double-blind parallel study design covering a total of 3 weeks).

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 data supports the effectiveness of the treatment Fermented Dairy Protein with Prebiotic Fiber for digestive health?

Research shows that fermented foods, like those containing probiotic bacteria, can improve gut health and reduce symptoms in gastrointestinal disorders. Additionally, prebiotic fibers are known to support healthy gut bacteria, which can help with digestive issues. ^{1 2 3 4 5}

Is Fermented Dairy Protein safe for human consumption?

Research on fermented dairy products, including those with probiotics and prebiotics, suggests they are generally safe for human consumption. Studies have shown improvements in digestive symptoms without significant side effects, indicating a good safety profile. ^{3 4 6 7 8}

How does the treatment Fermented Dairy Protein with Prebiotic Fiber differ from other treatments for digestive health?

This treatment is unique because it combines fermented dairy protein with prebiotic fiber, which may enhance protein quality and support gut health by promoting beneficial gut bacteria. Unlike standard treatments, it leverages the benefits of both probiotics and prebiotics to potentially improve digestive health and protein digestibility. ^{7 9 10 11 12}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Beneficial Propionibacteria within a Probiotic Emmental Cheese: Impact on Dextran Sodium Sulphate-Induced Colitis in Mice. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Fiber and prebiotic supplementation in enteral nutrition: A systematic review and meta-analysis. [2018]

3. England 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. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Randomised Controlled Trial: Partial Hydrolysation of Casein Protein in Milk Decreases Gastrointestinal Symptoms in Subjects with Functional Gastrointestinal Disorders. [2021]

5. Australia pubmed.ncbi.nlm.nih.gov

Increased mucin-degrading bacteria by high protein diet leads to thinner mucus layer and aggravates experimental colitis. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

A Fermented Milk Product with B. Lactis CNCM I-2494 and Lactic Acid Bacteria Improves Gastrointestinal Comfort in Response to a Challenge Diet Rich in Fermentable Residues in Healthy Subjects. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

A study on the effect of symbiotic fermented milk products on human gastrointestinal health: Double-blind randomized controlled clinical trial. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Health benefits of fermented milk containing Bifidobacterium bifidum YIT 10347 on gastric symptoms in adults. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Protein quality of a probiotic beverage enriched with pea and rice protein. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Does lactic fermentation influence soy yogurt protein digestibility: a comparative study between soymilk and soy yogurt at different pH. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

The effect of milk fermentation by Lactobacillus helveticus on the release of peptides during in vitro digestion. [2006]

12. United States pubmed.ncbi.nlm.nih.gov

Dynamic analysis of human small intestinal microbiota after an ingestion of fermented milk by small-intestinal fluid perfusion using an endoscopic retrograde bowel insertion technique. [2021]